Part 1 Preliminary
1 Name
of Regulations [see
Note 1]
These Regulations are the Therapeutic Goods
Regulations 1990.
2 Interpretation
In these Regulations, unless the contrary intention
appears:
active implantable therapeutic device:
(a) means an active therapeutic device designed
for implantation, totally or partially, into the human body:
(i) surgically; or
(ii) by other medical intervention,
into a natural orifice; and
(b) includes an accessory designed for use with
the device.
active ingredient has the same meaning as in
section 52F of the Act.
active therapeutic device means a device that
relies for its functioning on a source of electrical energy or any other source
of power that is not generated directly by the human body or by gravity.
analysis includes examination and testing.
antiseptic means a substance:
(a) that is recommended by its manufacturer for:
(i) dermal application; or
(ii) application to the mucous
membranes of a person or an animal:
(A) to kill micro organisms;
or
(B) to prevent the growth of
micro organisms to a level that causes or may cause clinical infection; and
(b) that is not represented to be suitable for
internal use.
ASMI means Australian Self‑Medication
Industry Incorporated (ABN 55 082 798 952).
authorised officer, in relation to a
provision of these Regulations, means an officer authorised by the Secretary to
exercise powers under that provision.
Note Regulation 2A provides for the
Secretary to authorise certain officers to exercise powers under provisions of
these Regulations.
Australian Approved Names List means the
document entitled Australian Approved Names List for Therapeutic Substances, as
in force from time to time, published by the Therapeutic Goods Administration.
Note 1 The Australian Approved Names
List includes:
(a) Australian Approved Names — Chemicals List; and
(b) Australian Approved Names — Biological Lists; and
(c) the Herbal Substances AAN List.
Note 2 The Australian Approved Names
List may be published as part of a larger document, for example, the document
entitled TGA Approved Terminology for Medicines.
CHCA means the Complementary Healthcare
Council of Australia.
Complaints Resolution Panel means the panel
established under regulation 42R.
complementary medicines has the same meaning
as in section 52F of the Act.
Complementary Medicines Evaluation Committee means
the Committee established under subsection 52G (1) of the Act.
critical medical device means a device that,
when used as recommended by its manufacturer, is in a sterile condition on
introduction into the human body.
designated orphan drug means an orphan drug designated
under subregulation 16J (2).
designated therapeutic goods means
therapeutic goods other than:
(a) therapeutic devices; and
(b) goods included in Schedule 3 to the Poisons
Standard that are not included in Appendix H of that standard; and
(c) goods included in Schedule 4 or 8 to the
Poisons Standard.
diagnostic goods for in vitro use means any
therapeutic device which is a reagent, reagent product, calibrator, control
material, kit, instrument, apparatus, equipment or system, whether used alone
or in combination (with other diagnostic goods for in vitro use),
intended by the manufacturer to be used in vitro for the examination of
specimens (including blood and tissue donations) derived from the human body,
solely or principally for the purpose of giving information about a
physiological or pathological state or a congenital abnormality or to determine
safety and compatibility with a potential recipient.
disinfectant means a substance:
(a) that is recommended by its manufacturer for
application to an inanimate object to kill micro organisms; and
(b) that is not represented by the manufacturer
to be suitable for internal use.
expiry date, for therapeutic goods, means the
date (expressed as the month and year) after which the goods should not be used.
fungicide means a chemical agent that kills a
fungus or spores of a fungus.
generic medicine means a medicine that, in
comparison to a registered medicine:
(a) has the same quantitative composition of
therapeutically active substances, being substances of similar quality to those
used in the registered medicine; and
(b) has the same pharmaceutical form; and
(c) is bioequivalent; and
(d) has the same safety and efficacy properties.
gene therapy means the in vivo transfer of
DNA or RNA into the cells of human recipients.
goods for home use, in relation to diagnostic
goods for in vitro use, means goods supplied to a person for that
person:
(a) to use in diagnosing or monitoring a
condition in that person or the immediate family of that person; or
(b) to use in the collection of a sample of a
body specimen of that person and, if the sample is tested by another person, if
and only if the results of the test are to be returned by that other person to
the person from whom the sample was taken.
herbal substance means all or part of a plant
or substance (other than a pure chemical or a substance of bacterial origin):
(a) that is obtained only by drying, crushing,
distilling, extracting, expressing, comminuting, mixing with an inert diluent
substance or another herbal substance or mixing with water, ethanol, glycerol
or aqueous ethanol; and
(b) that is not subjected to any other treatment
or process other than a treatment or process that is necessary for its
presentation in a pharmaceutical form.
high level disinfectant means a disinfectant
that:
(a) kills all microbial pathogens, except
bacterial endospores, when used as recommended by its manufacturer; and
(b) is the minimum treatment recommended by the
manufacturer of a semi critical medical device for the reprocessing of the
device.
homoeopathic
preparation means a preparation:
(a) formulated for use on the principle that it
is capable of producing in a healthy person symptoms similar to those which it
is administered to alleviate; and
(b) prepared according to the practices of
homoeopathic pharmacy using the methods of:
(i) serial dilution and succussion of
a mother tincture in water, ethanol, aqueous ethanol or glycerol; or
(ii) serial trituration in lactose.
hospital grade disinfectant means a disinfectant
that is represented to be suitable for therapeutic use:
(a) in premises used for:
(i) the investigation or treatment of
a disease, ailment or injury; or
(ii) procedures that are carried out
involving the penetration of the human skin; or
(b) in connection with:
(i) the business of beauty therapy or
hairdressing; or
(ii) the practice of podiatry;
but does not include:
(c) an antibacterial clothes preparation; or
(d) a sanitary fluid; or
(e) a sanitary powder; or
(f) a sanitiser.
household grade disinfectant means a
disinfectant that is not:
(a) an antibacterial clothes preparation; or
(b) a hospital grade disinfectant; or
(c) a sanitary fluid; or
(d) a sanitary powder; or
(e) a sanitiser.
immediate family, in relation to a person,
means the parents, grandparents, spouse, de facto spouse, child or ward
of that person.
implantable, in relation to a therapeutic
device, means designed to be implanted into the tissues or body cavities of a
person or animal, other than in the teeth, for a period of 30 days or
more.
instrument grade disinfectant means:
(a) a high level disinfectant; or
(b) a sterilant;
that is used to reprocess reusable semi critical or critical
medical devices.
mother tincture means a preparation prepared
by the process of solution, extraction or trituration to prepare homoeopathic
preparations.
NFAA means the Nutritional Foods Association
of Australia.
non critical medical device means a device
that, when used as recommended by its manufacturer:
(a) does not ordinarily contact the human body;
or
(b) if contact with the human body is made —
contacts only healthy intact skin.
official analyst means a person approved by
the Secretary under regulation 25.
open shelf life,
for therapeutic goods, means the time, after the container holding the goods is
opened, after which the goods should not be used.
Note For container, see
Act, subs 3 (1).
orphan drug has the meaning given by
regulation 16H.
OTC medicine means therapeutic goods
mentioned in Part 3 of Schedule 10.
pharmaceutical benefit means a Commonwealth
pharmaceutical benefit under the National Health Act 1953 or the Veterans’
Entitlements Act 1986.
Poisons Standard has the same
meaning as current Poisons Standard.
Practice Guidelines has the meaning given by
paragraph 12AB (2) (a).
principal investigator, in relation to a
clinical trial of therapeutic goods, means the person who is in charge of the
conduct of the trial.
quarter means a period of 3 months commencing
on 1 January, 1 April, 1 July or 1 October in a year.
rare disease means a disease, or condition,
likely to affect not more than 2,000 individuals in Australia at any time.
Required Advisory Statements for Medicine Labels
means the document of that name published by the Therapeutic Goods
Administration on 1 July 2004, as in force from time to time.
sample includes part of a sample.
semi critical medical device means a device
that, when used as recommended by its manufacturer:
(a) makes contact with healthy intact mucous
membranes of the human body; and
(b) does not ordinarily enter normally sterile
areas of the body.
serious, in relation to a form of a disease,
condition, ailment or defect, means a form of the disease, condition, ailment
or defect that is:
(a) generally accepted as not being appropriate
to be diagnosed or treated without consulting a suitably qualified health care
professional; or
(b) generally accepted to be beyond the ability
of the average person to evaluate accurately, or treat safely, without regular
supervision by a suitably qualified health care professional.
specialist has the same meaning as in the Health
Insurance Act 1973.
sporicide means a chemical agent that:
(a) kills bacterial spores; and
(b) has the potential to act as a sterilising
agent after prolonged contact with an inanimate object.
Standard AS/NZS means a joint
Australian and New Zealand Standard published by the Standards Australia
International Limited and the body known as Standards New Zealand.
sterilant means a chemical agent that kills
microbes with the result that the sterility assurance level of a microbial
survivor is less than 10‑6.
submission has the meaning given by subclause
1 (2) in Part 1 of Schedule 9.
the Act means the Therapeutic Goods Act
1989.
Therapeutic Goods Advertising Code means the
Code known as the Therapeutic Goods Advertising Code as in force from time to
time.
trade name, for therapeutic goods of a
particular kind, means the commercial name:
(a) given to goods of that kind by the
manufacturer; and
(b) under which the goods are supplied.
traditional use has the same meaning as in
section 52F of the Act.
tuberculocide means a chemical agent that
kills Mycobacterium tuberculosis and related acid‑fast bacteria.
unused emergency goods means goods to which
section 30G of the Act applies.
virucide means a chemical agent that renders
a virus non‑infective.
Note Definitions of medicine
and poison are in the Act (see subsection 3 (1)).
2A Authorised
officers
The Secretary may, in writing, authorise any of the
following persons to exercise powers under a specified provision of these
Regulations:
(a) an officer of the Department, of another
Department or of an authority of the Commonwealth;
(b) an officer of:
(i) a Department of State of a State;
or
(ii) a Department or administrative
unit of the Public Service of a Territory; or
(iii) an authority of a State or of a
Territory;
being a Department, unit or authority that
has functions relating to health matters.
3 Corresponding
State law
(1) In this regulation:
the Regulations means:
(a) the Therapeutic Goods Regulations 1990;
and
(b) the Therapeutic Goods (Medical Devices)
Regulations 2002.
(2) For the definition of corresponding State law
in subsection 3 (1) of the Act, the Therapeutic Goods (Victoria) Act
1994 is declared to correspond to the Act.
(3) For the definition of corresponding State law
in subsection 3 (1) of the Act, each of the following State laws is
declared to correspond to the Act and the Regulations:
(a) the Poisons and Therapeutic Goods Act
1966 (NSW);
(b) the Poisons and Therapeutic Goods
Regulation 2002 (NSW);
(c) the Therapeutic Goods Act 2001 (Tas);
(d) the Therapeutic Goods Regulations 2002
(Tas).
3A Unacceptable
presentations
(1) For paragraph 3 (5) (e) of the Act, any
labelling, packaging or presentation of therapeutic goods (including novelty
dosage forms in the shape of animals, robots, cartoon characters or other
similar objects) that is likely to result in those goods being mistaken for or
confused with confectionery or toys is an unacceptable presentation of the goods.
(2) For paragraph 3 (5) (e) of the Act, the
presentation of therapeutic goods is unacceptable if the name applied to the
goods is not sufficiently distinctive to allow for the identification of the
goods for the purposes of recovery.
Part 2 Advertisements
Division 1 Application of Part
4 Application
of Part 2
(1) This Part applies to advertisements to which Part 5‑1
of the Act applies.
(2) For subsection 42AA (2) of the Act, the bodies
mentioned in Schedule 1 are prescribed.
4A Interpretation
A term used in this Part and in Part 5‑1 of
the Act has the same meaning in this Part as it has in Part 5‑1 of the
Act.
Note See section 42B of the Act for
definitions of terms used in Part 5‑1 of the Act.
Division 2 Advertisements for which approval is needed
5B Interpretation
In this Division:
applicant means an applicant for approval of
an advertisement.
approval holder, in relation to an approved
advertisement, means the person to whom notice of approval of the advertisement
was given.
withdraw, in relation to an approved
advertisement, includes withdrawal by any delegate under subregulation
5Q (2) or (3), whether or not that delegate gave the approval and, in
the case of an approval given by the NFAA, includes a withdrawal by the CHCA.
5BA Means
that are not broadcast media
For the definition of broadcast media
in section 42B of the Act, in relation to an advertisement to which this
Division applies, each of the following means is declared to be an exempted
means:
(a) the Internet;
(b) electronic mail;
(c) narrowcast transmission, being a system the
reception of which is limited:
(i) by
being targeted to special interest groups; or
(ii) by being intended only for limited
locations (for example, arenas or business premises); or
(iii) by being provided during a
limited period or to cover a special event; or
(iv) because it provides programs of
limited appeal; or
(v) for any other reason;
(d) short message service (SMS), being a system
enabling the transmission of short text messages from a digital mobile
telephone to another digital mobile telephone;
(e) multimedia messaging service (MMS), being a
system enabling the transmission of visual communication, voice communication
or electronic mail from a digital mobile telephone to:
(i) another digital mobile telephone;
or
(ii) an electronic mail address.
5C Application of Division
(1) This Division applies to advertisements for
designated therapeutic goods published or inserted, or intended to be published
or inserted, for valuable consideration, in specified media.
(2) However, this Division does not apply to an
advertisement that consists only of one or more of the following:
(a) the brand name of the goods;
(b) the price of the goods;
(c) the type or style of the goods;
(d) a photographic or other reproduction of the
goods that does not contain any claim for therapeutic use in relation to the
goods;
(e) the locations or times at which the goods
are offered for sale;
(f) any other information reasonably necessary
to identify the person offering the goods for sale.
5F Applications
for approval of advertisements
An application for approval of an advertisement
must be:
(a) made to the Secretary in writing, in a form
approved by the Secretary; and
(b) signed by or on behalf of the applicant.
5G Approval
of advertisements
(1) If an application for approval of an advertisement
is made and the prescribed fee is paid, the Secretary must approve the
advertisement if the Secretary is satisfied that it:
(a) complies with the Therapeutic Goods Advertising
Code; and
(b) does not contain a prohibited representation
(whether in express terms or by necessary implication) about the goods; and
(c) contains a required representation about the
goods; and
(d) does not contain an unacceptable presentation
of the goods within the meaning of regulation 3A; and
(e) does not contain a restricted representation
about the goods the use of which has not been approved under section 42DF of
the Act or permitted under subsection 42DK (1) of the Act.
(3) Otherwise, the Secretary must refuse to approve the
advertisement.
(4) An approval may be subject to conditions imposed by
the Secretary.
5H Notice
of approval or refusal to approve an advertisement
(1) The Secretary must give written notice to the
applicant of the approval of, or of the refusal to approve, an advertisement.
(2) If written notice is not given to the applicant
within 60 days after the day on which the application was made, or within
such longer period as may be agreed in writing between the applicant and the
Secretary, the Secretary is taken to have approved the advertisement at the end
of the period.
(3) If an approval is subject to conditions, the
conditions must be set out in the notice.
(4) A notice of refusal to approve an advertisement
must:
(a) give the Secretary’s reasons for the
refusal; and
(b) inform the applicant of the applicant’s right
to have the Secretary’s decision reviewed by the Minister under regulation 5M.
5J Distinguishing
numbers for approved advertisements
(1) The Secretary must allocate a distinguishing
number (the approval number) to each approved advertisement.
(2) The Secretary must inform the applicant of the
approval number at the time of giving notice of the approval of the
advertisement.
(3) Unless the approval of the advertisement is
withdrawn, an approval number expires at the end of 2 years from the date on
which it is allocated.
5K Variation
of conditions of approval
(1) The Secretary, by written notice to an approval
holder, may vary any condition of approval of an approved advertisement.
(2) The notice must:
(a) give the Secretary’s reasons for the
variation; and
(b) inform the approval holder of the approval
holder’s right to have the Secretary’s decision reviewed by the Minister under
regulation 5M.
5L Withdrawal
of approval
(1) The Secretary, by written notice to an
approval holder, may withdraw the approval of an approved advertisement if the
Secretary is satisfied that:
(a) information given by the applicant in the
application was false or incorrect and the Secretary or the Minister relied on
the information in deciding to approve the advertisement; or
(b) a person has contravened section 42C of the
Act in relation to the advertisement; or
(c) there has been a breach of a condition of
approval; or
(d) because of a change to the facts or
circumstances existing when the advertisement was approved, the advertisement
no longer complies with the Therapeutic Goods Advertising Code; or
(e) because of a change to the Therapeutic Goods
Advertising Code, the advertisement no longer complies with the Code.
(2) The Secretary, by written notice to an approval
holder, may withdraw the approval of an approved advertisement on the
recommendation of the Complaints Resolution Panel following a complaint to the
Panel under subregulation 42ZCAB (1).
(3) The notice under subregulation (1) or (2) must:
(a) give the Secretary’s reasons for the
decision; and
(b) inform the approval holder of the approval
holder’s right to have the Secretary’s decision reviewed by the Minister under
regulation 5M.
5M Review
by Minister of decisions of the Secretary
(1) An applicant or approval holder who is
dissatisfied with a decision of the Secretary under regulation 5G, 5K or 5L may
request the Minister, in writing, to review the decision.
(2) The request must be made within 30 days after notice
of the decision is given to the applicant or approval holder.
(3) If an applicant requests a review of a decision of
the Secretary under regulation 5G, the applicant must at the same time send a
copy of the request to the Therapeutic Goods Advertising Code Council.
(4) The Minister must reconsider the decision of the
Secretary as soon as practicable after receiving a request, and may:
(a) confirm the Secretary’s decision; or
(b) revoke the Secretary’s decision and make a
decision (including a decision to impose conditions) in substitution for the
Secretary’s decision.
(5) In making a decision under subregulation (4), the
Minister must take into account any recommendation on the matter made by the
Therapeutic Goods Advertising Code Council or the Complaints Resolution Panel,
as the case requires.
(6) Until a decision is made by the Minister, the making
of a request does not affect the operation of the Secretary’s decision.
5N Notice
of Minister’s decisions
(1) The Minister must give written notice to the
applicant or approval holder of the decision of the Minister under
regulation 5M.
(2) If, in making a decision on review of a decision by
the Secretary under regulation 5G, the Minister does not accept a
recommendation of the Therapeutic Goods Advertising Code Council, the Minister
must notify the applicant of the fact.
(3) If the Minister’s decision is to approve an
advertisement subject to conditions, the conditions must be set out in the
notice.
(4) The notice must:
(a) give the Minister’s reasons for the
decision; and
(b) inform the
applicant or approval holder of the right of the applicant or approval holder
to apply to the Administrative Appeals Tribunal under regulation 5P for a review
of the Minister’s decision.
5P Review
by Tribunal of decisions of the Minister
An application may be made to the
Administrative Appeals Tribunal for a review of a decision of the Minister
under regulation 5M.
5Q Delegations
(1) The Minister may delegate, in writing, a power or
function of the Minister under regulation 5M or 5N to:
(a) an officer of the Department; or
(b) the National Manager, Therapeutic Goods
Administration.
(2) The Secretary may delegate, in writing, the
Secretary’s power under regulation 5G to approve or refuse to approve
advertisements to:
(a) an officer of the Department; or
(b) a medical practitioner registered in a State
or internal Territory who is employed by the government of a State or
Territory.
(3) The Secretary may delegate to the CHCA the
Secretary’s power under regulation 5G to approve or refuse to approve an
advertisement about designated therapeutic goods that are complementary
medicines if the advertisement is to be published or used in specified media of
the kind mentioned in paragraph (a), (c) or (d) of the definition of specified
media in section 42B of the Act.
(4) The Secretary may delegate to the ASMI the
following powers of the Secretary under regulation 5G:
(a) the power to approve or refuse to approve an
advertisement about designated therapeutic goods that are complementary
medicines if the advertisement is to be broadcast in broadcast media;
(b) the power to approve or refuse to approve an
advertisement about designated therapeutic goods that are not complementary
medicines if the advertisement is to be published or broadcast in specified
media.
(5) The Secretary may delegate the Secretary’s power
under regulation 5L to withdraw the approval of a class of approved
advertisements to a person to whom the Secretary has delegated the power to
approve the same class of advertisements.
(5A) The Secretary may delegate the Secretary’s power under
subregulation 5L (2) to withdraw the approval of approved advertisements to the
chairperson of the Complaints Resolution Panel.
(6) A person exercising a power under a delegation under
this regulation must comply with any conditions imposed or directions given by
the Minister or Secretary, as the case requires.
Division 3 General provisions about advertising therapeutic goods
6 Restricted
representations
For subsection 42DD (1) of the Act, Part 2 of
Appendix 6 to the Therapeutic Goods Advertising Code is prescribed.
6A Approval
of use of restricted representation — public interest criteria
For paragraph 42DF (4) (c) of the Act, Part 2 of
Appendix 6 to the Therapeutic Goods Advertising Code is prescribed.
6B Prohibited
and required representations
(1) For subsection 42DJ
(1) of the Act, the following representations are prohibited representations:
(a) the representations in column 2 of an item
in Part 1 of Schedule 2 about therapeutic goods in column 3 of that item;
(b) the representations in Part 1 of Appendix 6
to the Therapeutic Goods Advertising Code.
(2) For subsection 42DJ (2) of the Act, the representations
in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in
column 3 of that item are required representations.
7 Exempt
goods and exempt devices
(1) For subparagraph 42DL (1) (h) (i) of the Act, the
following exempt goods are prescribed:
(a) goods that are exempt from the operation of
Part 3‑2 of the Act under subregulation 12 (1A) or regulation 12A;
(b) goods specified in item 1 of Schedule 5.
(2) For subparagraph 42DL (1) (h) (i) of the Act, the
following exempt devices are prescribed:
(a) devices that are exempt from the operation
of Division 3 of Part 4‑11 of the Act under subregulation 7.1 (2) or
regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;
(b) devices of a kind mentioned in item 1.1 of
Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002.
Division 4 Generic information about ingredients or components of
therapeutic goods
8 Compliance
with the Code
For section 42DO of the Act, the principles stated
in subsections 4 (1), (2), (3), (4), (5) and (6) of the Therapeutic
Goods Advertising Code are specified.
8A Publication
of generic information
For paragraph 42DP (1) (b) of the Act, the
principles contained in subsections 4 (1), (2), (3), (4), (5) and (6)
of the Therapeutic Goods Advertising Code are specified.
Division 5 General
9 Orders about advertisements or generic
information
(1) On the recommendation of the Complaints Resolution
Panel under subregulation 42ZCAI (3) in relation to an advertisement or generic
information about therapeutic goods, the Secretary, by written notice, may
order a person to do one or more of the following:
(a) withdraw the advertisement or generic
information;
(b) publish a retraction;
(c) publish a correction;
(d) recover any advertisement or generic
information that is still in circulation;
(e) destroy the advertisement or generic
information;
(f) withdraw a particular claim or
representation made by the advertisement or generic information, and not use
that claim or representation in any other advertisement or generic information
unless the person satisfies the Secretary that the use of the claim or
representation would not result in a contravention of the Act, these
Regulations or the Therapeutic Goods Advertising Code.
(2) An order under subregulation (1) may be subject to
conditions imposed by the Secretary.
(3) The Secretary may delegate all or any of the
Secretary’s powers under subregulation (1) to the chairperson of the Complaints
Resolution Panel.
Part 2A Patient information
9A Information
about certain therapeutic goods to be supplied
(1) The sponsor of therapeutic goods that are specified
in Part 1 of Schedule 10 must not supply the goods if the sponsor does not
supply with the goods written information about the goods that meets the
requirements for a patient information document set out in Schedule 12.
Penalty: 10 penalty
units.
Note Additional information must be
provided in relation to certain therapeutic goods (other than medical devices)
that are manufactured using a human embryo or human embryonic stem cell, or any
other material sourced from a human embryo or human embryonic stem cell —
see regulation 9B.
(1AAA) For subregulation (1), strict
liability applies to the physical element that the goods are specified in Part
1 of Schedule 10.
Note For strict liability,
see section 6.1 of the Criminal Code.
(1AA) It is a defence to a prosecution under subregulation (1)
if the goods are specified in Schedule 3 to the Poisons Standard.
Note A defendant bears an evidential
burden in relation to the matters mentioned in subregulation (1AA) (see section
13.3 of the Criminal Code).
(1A) The sponsor of therapeutic goods that are:
(a) specified in Schedule 3 of the Poisons
Standard; and
(b) are approved for registration on or after 4
July 1995;
must not supply the goods if the sponsor does not supply with the
goods written information about the goods that meets the requirements for a
patient information document set out in Schedule 13.
Penalty: 10 penalty units.
(1B) For the purposes of an
offence under subregulation (1A), strict liability applies to the physical
element mentioned in paragraph (1A) (a).
Note For strict liability,
see section 6.1 of the Criminal Code.
(2) For the purposes of subregulation (1) or (1A), information
must be provided:
(a) in the primary pack in which the therapeutic
goods are supplied; or
(b) in another manner that will enable the
information to be given to a person to whom the goods are administered or
otherwise dispensed.
9B Information
about therapeutic goods manufactured using human embryos
(1) A sponsor of therapeutic goods (other than medical
devices) commits an offence if:
(a) the sponsor supplies the goods on or after 1
July 2004; and
(b) the sponsor knows the goods were manufactured
using a human embryo or human embryonic stem cell, or other material sourced
from a human embryo or human embryonic stem cell; and
(c) the goods are of a kind specified in Part 1
of Schedule 10; and
(d) on or after 1 July 2004, the goods are
included in the part of the Register for goods known as registered goods; and
(e) the goods are supplied without written
information stating that the goods were manufactured using a human embryo or
human embryonic stem cell, or other material sourced from a human embryo or
human embryonic stem cell.
Penalty: 10 penalty units.
(2) Strict liability applies to the physical elements
mentioned in paragraphs (1) (c), (d) and (e).
(3) The information in relation to the therapeutic goods
must be included in:
(a) the patient information document required
under regulation 9A; and
(b) the product information in relation to the
goods.
(4) In this regulation:
human embryo means a live embryo that has a
human genome or an altered human genome and that has been developing for less
than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of
its development by other means.
human embryonic stem cell means
undifferentiated cells derived from a human embryo that have the potential to
become a wide variety of specialised cell types.
product information, in relation to
therapeutic goods, has the meaning given by subsection 9D (5) of the Act.
(5) For the purposes of the definition of human
embryo in subregulation (4), in working out the length of the period of
development of a human embryo, any period when the development of the embryo is
suspended is to be disregarded.
Part 2C Australian Register of Therapeutic Goods
Division 2C.1 Registered and listed therapeutic goods
10 Goods
to be included in parts of the Register (Act s 9A)
For paragraph 9A (4) (a) of the Act:
(a) therapeutic goods, and classes of
therapeutic goods, of a kind mentioned in Schedule 3 that are included in the
Register are to be included in the part of the Register for registered goods;
and
(b) therapeutic goods, and classes of therapeutic
goods, of a kind mentioned in Part 1 of Schedule 4 that are included in the
Register are to be included in the part of the Register for listed goods.
10A Change
of person in whose name goods are listed or registered
(1) If a person in relation to whom therapeutic goods
are registered or listed dies, the legal personal representative of the dead
person:
(a) is taken to be the person in relation to
whom the therapeutic goods are registered or listed; and
(b) must notify the Secretary, in writing, of the
death not later than 3 months after it occurred.
(2) If a person in relation to whom therapeutic goods
are registered or listed becomes bankrupt, the trustee in bankruptcy of the
estate of the bankrupt:
(a) is taken to be the person in relation to
whom the therapeutic goods are registered or listed; and
(b) must notify the Secretary, in writing, of the
bankruptcy not later than 3 months after the person became bankrupt.
(3) If a body corporate in relation to which therapeutic
goods are registered or listed is being wound up, the liquidator of the body
corporate:
(a) is taken to be the person in relation to
whom the therapeutic goods are registered or listed; and
(b) must, not later than 3 months after the body
corporate is wound up, notify the Secretary, in writing, of the winding up.
(4) If:
(a) a person agrees to dispose of a business
relating to the manufacture, distribution or sale of therapeutic goods; and
(b) it is agreed that the disposal of that business
is to include a transfer of the registration or listing of therapeutic goods;
then:
(c) the person who acquires that business is
taken to be the person in relation to whom the therapeutic goods are registered
or listed; and
(d) that person must, not later than 3 months
after the transfer, notify the Secretary that the person has, by reason of that
agreement, become the person in relation to whom the goods are to be registered
or listed.
(4A) If a person in relation to whom therapeutic goods are
registered or listed:
(a) changes his, her or its name; or
(b) being a corporation, amalgamates with another
corporation under a name that is different from the name of the person in the
Register;
the person must give notice in writing to the Secretary of the new
name of the person, and the circumstance giving rise to it, within 3 months
after the occurrence of the circumstance.
(4B) The new name must be entered in the Register as the
name of the person in relation to whom the therapeutic goods are registered or
listed.
(5) When a person notifies the Secretary of an event
referred to in paragraph (1) (b), (2) (b), (3) (b) or (4) (d) or subregulation
(4A), the person must send to the Secretary sufficient documentary evidence to
establish the matter asserted in the notification.
(6) If the Secretary is informed of the transfer of
registration or listing of any therapeutic goods, or of the new name of a
person and the circumstance giving rise to it, in accordance with this
regulation, the Secretary must amend the Register accordingly.
(7) If, at any time, the Secretary becomes aware that he
or she has not been informed of the transfer of registration or listing in
respect of any therapeutic goods, or of the new name of a person and the
circumstance giving rise to it, in accordance with this regulation, the
Secretary may cancel the registration or listing of those goods.
(8) As soon as practicable after the Secretary has
amended the Register in accordance with subregulation (6), the Secretary must
give to the person in whose name the goods are registered or listed a
certificate of registration or listing of the goods.
(9) If the Secretary:
(a) amends the Register in accordance with
subregulation (6); or
(b) cancels the registration or listing of goods
under subregulation (7);
the person who has the certificate
issued under subsection 25 (4) or 26 (4) of the Act or subregulation
(8) must return it as soon as practicable to the Secretary.
Penalty: 5 penalty units.
(10) An offence under subregulation (9) is an offence
of strict liability.
Note For strict liability,
see section 6.1 of the Criminal Code.
10B Transfers
within the Register
(1) If goods (other than medical devices) that are
included in the part of the Register for listed goods become subject to inclusion
in the part of the Register for registered goods, the person in whose name the
goods are entered in the Register must apply to the Secretary to transfer the
entry in relation to the goods to the part of the Register for registered
goods.
(2) An application under subregulation (1) must be made:
(a) if the Secretary notifies the person in
whose name the goods are entered in the Register of a reasonable period within
which the application must be made — within that period; or
(b) in any other case — not later than 15
months after the day on which the goods became subject to inclusion in the part
of the Register for registered goods.
Penalty: 5 penalty units.
(2A) An offence under subregulation (2) is an offence
of strict liability.
Note For strict liability,
see section 6.1 of the Criminal Code.
(3) In determining a period of notice for the purposes
of paragraph (2) (a) the Secretary is to have regard to:
(a) the ability of the person in whose name the
goods are entered in the Register to provide the information necessary to
support the transfer of the entry; and
(b) the reasons for the transfer in relation to
the protection of the public.
(4) It is not an offence for the sponsor of goods to
which subregulation (1) applies to import, export, supply or manufacture the
goods as listed goods until the time for making the application under
subregulation (2) has expired or, if an application is made, until it is
determined, whichever is the later.
(5) If goods (other than medical devices) that are
included in the part of the Register for registered goods become subject to
inclusion in the part of the Register for listed goods, the person in whose
name the goods are entered in the Register may apply to the Secretary:
(a) to transfer the entry in relation to the
goods to the part of the Register for listed goods; or
(b) to retain the entry in the part of the
Register for registered goods.
(6) If:
(a) goods are included in the Register under
Chapter 4 as a kind of medical device; and
(b) the goods cease to be a medical device
because of a declaration under subsection 41BD (3) of the Act;
the person in relation to whom the kind of device is included in
the Register may apply to the Secretary to transfer the entry in relation to
the goods to the part of the Register for registered goods or the part of the
Register for listed goods, as the case requires.
(7) An application to transfer an entry in relation to
goods from a part of the Register to the part of the Register for registered
goods, or the part of the Register for listed goods, is to be treated as an
application for registration or listing of the goods, as the case requires.
10C Re‑assignment
of registration or listing numbers
(1) A person in whose name therapeutic goods or grouped
therapeutic goods are registered or listed may apply for the therapeutic goods
to be assigned a different registration or listing number.
(2) An application:
(a) must be made in writing to the Secretary and
delivered to an office of the Department; and
(b) must have with it written information in such
detail as is reasonably necessary to allow the application to be properly
considered; and
(c) may contain a nomination referred to in
subparagraph (6) (b) (ii).
(3) The Secretary may assign to therapeutic goods that:
(a) were grouped therapeutic goods when a
registration or listing number was assigned, or last assigned, to the goods;
and
(b) are not grouped therapeutic goods when:
(i) the application is decided; or
(ii) an order is made under section 16
of the Act in relation to the goods;
a registration or listing number that is not assigned to other
therapeutic goods or grouped therapeutic goods.
(4) The Secretary must assign to grouped therapeutic
goods that:
(a) were in a gazetted therapeutic devices group
or a gazetted therapeutic goods group when a registration or listing number was
assigned, or last assigned, to the goods; and
(b) are in a gazetted therapeutic devices group,
or a gazetted therapeutic goods group, other than a group referred to in
paragraph (a), when:
(i) the application is decided; or
(ii) an order is made under section 16
of the Act in relation to the goods;
a registration or listing number that is not assigned to other
therapeutic goods or grouped therapeutic goods.
(5) The Secretary must assign to therapeutic goods that:
(a) were not grouped therapeutic goods when a
registration or listing number was assigned, or last assigned, to the goods;
and
(b) are grouped therapeutic goods when:
(i) the application is decided; or
(ii) an order is made under section 16
of the Act in relation to the goods;
a registration or listing number in accordance with subregulation
(6).
(6) The Secretary:
(a) may assign to grouped therapeutic goods to
which subregulation (5) applies another registration or listing number; and
(b) must assign to those goods a registration or
listing number that:
(i) was assigned, or last assigned, to
the goods; and
(ii) is nominated by the person in
whose name the goods are registered or listed;
not being a registration or listing number that is assigned to
other therapeutic goods or grouped therapeutic goods.
10D Notice
of reassignment of registration or listing numbers
The Secretary must give notice, in writing, to a
person in whose name therapeutic goods, or kinds of therapeutic goods, are
registered or listed if a registration or listing number is assigned to the
goods under regulation 10C.
Division 2C.2 Medical devices included in the Register under Chapter 4
10E Goods
to be included in part of the Register for medical devices (Act s 9A)
For paragraph 9A (4) (a) of the Act,
therapeutic goods, and classes of therapeutic goods, that are medical devices
and that are included in the Register under Chapter 4 of the Act are to be
included in the part of the Register for medical devices.
10F Change
of person in relation to whom a medical device is included in the Register
under Chapter 4 of the Act
(1) If a person in
relation to whom a kind of medical device is included in the Register under
Chapter 4 of the Act dies, the legal personal representative of the person:
(a) is taken to be the person in relation to
whom the kind of device is included in the Register under that Chapter; and
(b) must notify the Secretary, in writing, of the
death within 3 months after it occurred.
(2) If a person in
relation to whom a kind of medical device is included in the Register under
Chapter 4 of the Act becomes bankrupt, the trustee in bankruptcy of the estate
of the bankrupt:
(a) is taken to be the person in relation to
whom the kind of device is included in the Register under that Chapter; and
(b) must notify the Secretary, in writing, of the
bankruptcy within 3 months after the person became bankrupt.
(3) If a body corporate in relation to which a kind of
medical device is included in the Register under Chapter 4 of the Act is wound
up, the liquidator of the body corporate:
(a) is taken to be the person in relation to
whom the kind of device is included in the Register under that Chapter; and
(b) must notify the Secretary, in writing, of the
winding up within 3 months after the body corporate is wound up.
(4) If a person in relation to whom a kind of medical
device is included in the Register under Chapter 4 of the Act:
(a) changes his, her or its name; or
(b) being a corporation, amalgamates with another
corporation under a name that is different from the name entered in the
Register;
the person must, within 3 months after the change of name or
amalgamation:
(c) notify the Secretary, in writing, of the new
name of the person and the circumstance giving rise to it; and
(d) return the certificate of the inclusion of
the kind of device in the Register given under subsection 41FF (2) of the
Act.
(5) If a person notifies the Secretary of an event under
paragraph (1) (b), (2) (b) or (3) (b), or a change of name under
subregulation (4), the person must send to the Secretary sufficient documentary
evidence to establish the matter asserted in the notification.
(6) If, under subregulation (4), the Secretary is
notified of a new name for a person in relation to whom a kind of medical
device is included in the Register under Chapter 4 of the Act, the Secretary
must:
(a) enter the new name in the Register as the
name of the person in relation to whom the kind of device is included in the
Register under that Chapter; and
(b) as soon as practicable after entering the new
name, give to the person a new certificate of the inclusion of the kind of
device in the Register under that Chapter.
(7) If, at any time, the Secretary becomes aware that he
or she has not been informed of a change in the name of a person in relation to
whom a kind of medical device is included in the Register under Chapter 4 of
the Act, the Secretary may cancel the entry in the Register in relation to the
kind of device.
(8) If, under this regulation, the Secretary:
(a) changes the name of a person in relation to
whom a medical device is included in the Register under Chapter 4 of the Act;
or
(b) cancels an entry in the Register in relation
to a kind of medical device;
the Secretary must, as soon as practicable after changing the name
or cancelling the entry:
(c) notify the person in relation to whom the
kind of device was included in the Register that the name has been changed or
the entry in the Register has been cancelled; and
(d) ask the person to return to the Secretary the
certificate of the inclusion of the kind of device in the Register given under
subsection 41FF (2) of the Act.
(9) If a person in relation to whom a kind of device is
included in the Register under Chapter 4 of the Act receives a notice under
subregulation (8), the person must return to the Secretary, as soon as
practicable after receiving the notice, the certificate of the inclusion of the
kind of device in the Register under that Chapter that was given before the
change of name or cancellation.
Penalty: 5 penalty units.
(10) An offence against subregulation (9) is an offence of
strict liability.
Note For strict liability,
see section 6.1 of the Criminal Code.
Part 3 Registration, listing and exemption of therapeutic goods
11 Characteristics
that separate and distinguish certain medicines from other therapeutic goods
(1) For paragraph 16 (1A) (d) of the Act,
different characteristics are:
(a) a different name; or
(b) different indications; or
(c) a different excipient; or
(d) for medicines
that contain any restricted ingredients:
(i) a different quantity of a
restricted ingredient that is an excipient; or
(ii) if the restriction on a restricted
ingredient relates to its concentration in a relevant medicine — a
different concentration of the restricted ingredient; or
(iii) if the restriction on a
restricted ingredient relates to its quantity in the recommended single or
daily dose in a relevant medicine — different directions for use setting
out a different recommended single or daily dose.
(2) A substance is a restricted
ingredient if:
(a) it is an ingredient in a relevant medicine;
and
(b) for that
medicine to be, or to remain, eligible for listing, the permissible quantity or
concentration of the substance in the medicine is restricted by operation of
any of the following:
(i) Schedule 4;
(ii) the Poisons Standard;
(iii) a condition imposed under section
28 of the Act;
(iv) a standard under section 10 of the
Act;
(v) the Required Advisory Statements
for Medicine Labels;
(vi) any other provision in these
Regulations or in the Act that deals with eligibility of medicines for listing.
(3) In this regulation:
relevant medicine means a medicine that is
listable goods or listed goods and that is not an export only medicine.
12 Exempt
goods
(1) For the purposes of subsection 18 (1) of the
Act, the therapeutic goods or classes of therapeutic goods specified in
Schedule 5 are exempt from the operation of Part 3‑2 of the Act (except
sections 30EA, 31A and 31C to 31F).
(1AA) For the purposes of item 7 in Schedule 5, a device or
part of a device:
(a) is powered if the whole or part of the
energy applied to it comes from a source other than the application of human
energy; and
(b) is non‑powered if paragraph (a) does
not apply.
(1A) For the purposes of subsection 18 (1) of the Act,
the therapeutic goods or classes of therapeutic goods specified in an item in
column 2 of Schedule 5A are exempt from the operation of Part 3‑2 of the
Act (except sections 30EA, 31A and 31C to 31F) subject to compliance with the
relevant conditions specified in column 3 of that Schedule.
(2) If:
(a) therapeutic goods that, in relation to a
provision of Part 3‑2 of the Act, are exempt goods cease to be exempt
goods; and
(b) the sponsor of the goods has applied for
registration or listing of the goods before the goods cease to be exempt goods;
the goods are taken to be exempt goods until the application for
registration or listing is determined.
12A Unapproved
medicines — exemption in
life‑threatening cases
(1) For the purposes of subsection 18 (1) of the
Act, all medicines, other than medicines of a class or kind listed in the
9th Schedule to the Poisons Standard, as in force from time to time, are
exempted, subject to subregulation (2), from the operation of Part 3‑2 of
the Act (except section 31A and sections 31C to 31F).
(2) The exemption of a medicine is subject to the
following conditions:
(a) the medicine is to be given to a person who
satisfies the following criteria:
(i) the person is a Category A patient
(as defined in subregulation (5)); and
(ii) the person, or the guardian of the
person, has given informed consent (as defined in subregulation (5)) to the
medicine being given to the person; and
(iii) the medical practitioner by whom,
or at whose direction, the medicine is to be given to the person has signed a
statement in relation to the person in the form approved by the Secretary for
the purposes of this paragraph; and
(b) the medicine is dispensed on the prescription
of a medical practitioner who has prescribed the medicine in accordance with
good medical practice.
(3) A person who signs a statement referred to in
subparagraph (2) (a) (iii) must send a copy of the statement to the
Secretary within 4 weeks of signing it.
Penalty: 10 penalty units.
(3A) An offence under subregulation (3) is an offence
of strict liability.
Note For strict liability,
see section 6.1 of the Criminal Code.
(4) This regulation does not affect the operation of
regulation 12.
(5) In this regulation:
Category A patient means a person who is
seriously ill with a condition from which death is reasonably likely to occur
within a matter of months, or from which premature death is reasonably likely
to occur in the absence of early treatment.
informed consent, in relation to treatment or
proposed treatment, means consent freely given by a person on the basis of
information concerning the potential risks and benefits of the treatment that
was sufficient information to allow the person to make an informed decision
whether to consent to the treatment.
12AAA Emergency
goods — early cessation of exemption
(1) This regulation applies to:
(a) a revocation, under
paragraph 18A (4) (b) of the Act, of an exemption of therapeutic
goods under subsection 18A (1) of the Act; and
(b) a variation, under paragraph 18A (5) (b)
of the Act, of an exemption under subsection 18A (1) of the Act, that
removes particular therapeutic goods from the exemption.
(2) The Secretary must give notice of the revocation or
variation to persons who, under the exemption, have been importing,
manufacturing, supplying or exporting the goods by:
(a) writing to the person; or
(b) publication in the Gazette.
(3) A notice given under subregulation (2) must:
(a) identify the goods covered by the revocation
or variation; and
(b) state the date that the exemption ceases to
have effect for the goods.
12AAB Disposal
of unused emergency goods
(1) For subsection 30G (2) of the Act,
Schedule 5B sets out the requirements of, and in relation to, an
arrangement for disposal of unused emergency goods.
(2) Nothing in this regulation or in Schedule 5B is
taken to prevent a disposal of unused emergency goods if:
(a) the goods have become (whether in relation
to an indication for which the goods could have been used under the exemption
or in relation to a different indication):
(i) registered goods or listed goods;
or
(ii) exempt goods under section 18
of the Act; or
(iii) goods that are the subject of an
approval or authority under section 19 of the Act; or
(iv) goods that are the subject of an
approval under section 19A of the Act; and
(b) the disposal is in accordance with other
provisions of the Act and these Regulations relevant to the goods.
12AA Applications
for special and experimental uses
Without limiting the information that may be
required by the Secretary under subsection 19 (2) of the Act, that
information may include, in relation to therapeutic goods the subject of an
application under subsection 19 (1) of the Act for a use described in
paragraph 19 (1) (b) of the Act:
(a) the names of the members of the ethics
committee that has given approval for each proposed clinical trial of the goods
and that will have responsibility for monitoring the conduct of each trial; and
(b) the name of, and the contact details for, the
principal investigator for each trial; and
(c) the name of the person who will be in charge
of the trial site (or each trial site, if the trial is to be conducted at more
than 1 site), unless that person is the principal investigator; and
(d) information about whether or not any
conditions specified by the committee have been met.
12AB Goods imported etc for experimental uses
(1) For subsection 19 (1A) of the Act, this
regulation specifies conditions attaching to an approval for the importation or
supply of therapeutic goods for use solely for experimental purposes in humans.
(2) Before any clinical
trials proposed to be undertaken in relation to the goods are started, the
National Manager, Therapeutic Goods Administration, must receive from the
person to whom the approval is granted, and the principal investigator for each
trial site:
(a) a written assurance that clinical trials
will be conducted in accordance with the Guidelines for Good Clinical Practice
(the Practice Guidelines), as in force from time to
time, published jointly by the International Conference
on Harmonisation on Technical Requirements for Registration of Pharmaceuticals
for Human Use and the Committee for Medicinal Products; and
(b) a written
undertaking:
(i) to comply with requests by an
authorised officer, whether made before or after the start of the trial, to
give information about the conduct of the trial; and
(ii) allow an authorised officer to do
the things mentioned in regulation 12AC.
12AC Powers of authorised officers in relation to
goods imported etc for experimental uses
(1) An authorised officer
may, in relation to a clinical trial mentioned in regulation 12AB:
(a) enter the site of the trial; and
(b) search the site and any thing on the site;
and
(c) inspect, examine, take measurements of, or
conduct tests on (including by the taking of samples), any thing on the site
that relates to the trial; and
(d) take photographs, make video recordings or
make sketches of the site or any thing on the site; and
(e) inspect any book, record or document on the
site that relates to the trial; and
(f) request the
principal investigator to:
(i) answer any questions put by the
authorised officer; and
(ii) produce any book, record or
document requested by the authorised officer.
(2) An authorised officer
is not entitled to do a thing mentioned in subregulation (1) if:
(a) the principal investigator, or any other
person present at the site concerned and in apparent control, requests the
authorised officer to produce his or her identity card for inspection; and
(b) the authorised officer fails to comply with
the request.
Note For identity cards, see
section 52 of the Act.
(3) The principal investigator, or any other person
present at the site and in apparent control, is entitled to observe a search
conducted under paragraph (1) (b), but must not impede the search.
(4) Subregulation (3) does not prevent 2 or more
areas of the site being searched at the same time.
12AD Use of goods for experimental purposes —
specified conditions
For subsection
19 (4A) of the Act, the following conditions are specified:
(a) the use of therapeutic goods in a clinical
trial must be in accordance with the Practice Guidelines;
(b) the use must comply with a procedural
protocol approved by the ethics committee that has the function of monitoring
the conduct of the trial at each trial site;
(c) the use must be in accordance with the
ethical standards set out in the National Statement on Ethical Conduct in
Research Involving Humans, as in force from time to time, published by the
National Health and Medical Research Council;
(d) the use must
cease if the ethics committee mentioned in paragraph (b) informs the
principal investigator that the use is inconsistent with:
(i) the protocol mentioned in
paragraph (b); or
(ii) any condition subject to which
approval for the use was given.
12B Exemptions for special and experimental
uses
(1) For the purposes of paragraph 19 (6) (a)
of the Act, in relation to medicines, medical practitioners engaged in clinical
practice in or outside a hospital are a prescribed class of medical
practitioners.
(1A) For the purposes of subsection 19 (6) of the Act,
in relation to medicines, paragraph 19 (6) (aa) does not apply to a
medical practitioner engaged in clinical practice outside a hospital if the
medical practitioner:
(a) has demonstrated that, in relation to the
proposed supply of the medicines, the medical practitioner does not have access
to an ethics committee that could approve the supply; and
(b) has received an endorsement, from a
specialist college with established expertise relevant to the use of the
medicines, to supply the medicines.
(2) The class of recipients prescribed for the purposes
of paragraph 19 (6) (b) of the Act is the class of recipients
consisting of persons each of whom is suffering from a life‑threatening,
or otherwise serious, illness or condition.
(3) For the purposes of subsection 19 (7) of the
Act, the prescribed circumstances in which a medicine, or a class of medicines,
may be supplied in accordance with an authority under
subsection 19 (5) of the Act are that the supplier of the medicine or
class of medicines complies with the treatment directions (if any) mentioned in
the authority for the medicine or class of medicine.
(4) For the purposes of subsection 19 (7) of the
Act, the prescribed circumstances in which a therapeutic device, or a class of
therapeutic devices, may be supplied in accordance with an authority under
subsection 19 (5) of the Act are:
(a) that, in each
case, the medical practitioner authorised under subsection 19 (5) of the
Act:
(i) is a specialist engaged in
clinical practice at a hospital; and
(ii) is endorsed by the relevant ethics
committee of the hospital; and
(b) that the authority states the particular
therapeutic intervention, or class of therapeutic intervention, for which the
medical practitioner may supply the therapeutic device or class of therapeutic
devices.
12C Application
of Part 3‑2 to medical devices (Act s 15A)
For subparagraph 15A (5) (a) (ii) of
the Act, a kind of medical device is specified if:
(a) it is a medical device of a kind that is
manufactured in Australia by a person mentioned in column 2 of Schedule 8,
as in force immediately before the commencement of the Therapeutic Goods
Amendment (Medical Devices) Act 2002; and
(b) it is manufactured in the circumstances set
out in column 3 of that Schedule, as in force immediately before that
commencement.
Note Schedule 8 identifies persons who
are exempt from the operation of Part 3‑3 of the Therapeutic Goods Act
1989 in relation to the manufacture or a step in the manufacture of
therapeutic goods or a class of therapeutic goods — see subsection
34 (2) of the Act and regulation 18.
15 Application
of registration or listing number to goods
(1) For the purposes of
paragraph 20 (2) (a) of the Act, the registration number or
listing number of therapeutic goods is to be set out on the label of the goods
in the following manner:
(a) in the case of a therapeutic device included
in the part of the Register for registered goods — by writing the number
so that it is clearly visible to the user:
(i) on the label on the device; or
(ii) on the label on the outermost
level of packaging in which the device is to be supplied to its user;
and, where more than one device is packaged
for supply together, on the label on the outermost surface of the outermost
package; and
(b) in the case of medicines — by writing
the number on the label on the container of the medicines, or, if the container
is enclosed in a primary pack for supply, on the label on that primary pack;
and
(c) subject to subregulation (2), in each
case — by writing the number on the main label, or on a securely affixed sticker
adjacent to the main label, immediately preceded by:
(i) “AUST R” in the case of registered
goods; and
(ii) “AUST L” in the case of listed
goods;
the numbers and letters in each case being
not less than 1 millimetre in height.
(2) If the Secretary is satisfied that compliance with
paragraph (1) (c) in a particular case is not practicable, he or she may
give a direction in writing that states an alternative manner in which the
relevant number, immediately preceded by the appropriate letters stated in
subparagraphs (1) (c) (i) or (ii), is to be set out, and in that case
the number and letters are to be set out in accordance with the direction.
15A Conditions
of registration of therapeutic goods
(1) For the purposes of paragraph 28 (5) (e)
of the Act, a person to whom the registration of a therapeutic good specified
in Part 1 of Schedule 10 relates must comply with the reporting requirements
set out in the document entitled ‘Australian Guideline For Pharmacovigilance
Responsibilities Of Sponsors Of Registered Medicines Regulated By Drug Safety
And Evaluation Branch’ published by the Therapeutic Goods Administration, as in
force from time to time.
(2) For the purposes of subregulation (1), a reference
to a registered medicine or a registered medicinal product in the document
mentioned in that subregulation is taken to be a reference to a therapeutic
good.
16 Listing
of Therapeutic Goods
(1) For the purposes of paragraph 26 (1) (g)
of the Act, the therapeutic devices specified in Schedule 6 are prescribed.
(2) For the purposes of paragraph 26 (1) (k)
of the Act, the criteria stated in Part 2 of Schedule 11 are prescribed for
therapeutic goods of the kinds stated in Part 1 of that Schedule.
16AA Documents
and other information that may be required (Act subs 31 (2))
For paragraph 31 (2) (h) of the
Act, the following matters are prescribed:
(a) the quality of the goods;
(b) the efficacy of the goods for the purposes
for which the goods are to be used.
Part 3A Applications for evaluation
Division 1 Goods mentioned in Part 1 of Schedule 10
16A Interpretation —
working day
(1) In this Part, working day means a day
that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth
offices in the Australian Capital Territory.
(2) The following periods are to be disregarded in
calculating, for the purposes of a provision of this Part, the number of
working days taken to perform the action that the provision requires to be
performed:
(a) the period commencing on the day on which
the Secretary sends a query, or a request for information, to an applicant or
sponsor and ending at the end of the day on which the Secretary receives from
the applicant or sponsor a complete response to the query or request; and
(b) the period commencing on the day of lodgment
of an appeal concerning the application for which the action is required to be
performed and ending at the end of the day on which the appeal is finally
disposed of; and
(c) any other period to which the applicant or
sponsor agrees in writing for the purposes of this subregulation.
16B Notification
of acceptance or rejection of application
(1) If the Secretary receives an application:
(a) under section 23 of the Act that requires an
evaluation to which regulation 16C applies; or
(b) to which regulation 16D applies;
he or she must send a notification in writing to the applicant that
states whether the application has been accepted or rejected.
(2) A notification must
be sent:
(a) if the application to which it relates is
one that satisfies the conditions stated in subregulation 16C (4) or
16D (4) — within 20 working days; or
(b) in any other case — within 40 working
days;
of the day of receipt of the application.
16C Periods within which certain evaluations
must be made
(1) Subject to paragraph (4) (d), this regulation
applies to an evaluation of a medicine that is a product of a kind specified in
Part 1 of Schedule 10 if the application in relation to the evaluation:
(a) is received by the Secretary on or after 1
February 1992; and
(b) requires an evaluation under section 25 of
the Act; and
(c) is not an application to which subregulation
16G applies.
(2) A reference in this regulation to a period in
relation to an evaluation to which this regulation applies is a reference to
the period that commences on the day on which the Secretary sends a
notification to the applicant under regulation 16B that indicates acceptance of
the application in relation to the evaluation.
(3) An evaluation to which this regulation applies must
be completed within whichever of the following periods applies:
(a) if the evaluation satisfies the conditions
stated in subregulation (4) — 175 working days;
(b) in any other case — 255 working days.
(4) The conditions referred to in paragraph (3) (a)
are:
(a) that the evaluation relates to a medicine
that, in each of 2 acceptable countries, has been approved for general
marketing;
(b) that the formulation, directions for use and
indications of the medicine are identical to those evaluated and approved for
marketing in those 2 countries; and
(c) that the Secretary has, in relation to the
evaluation, 2 evaluation reports on the medicine that satisfy the
requirements of subregulation (5); and
(d) that the application is received by the
Secretary on or after 1 September 1992.
(5) The requirements referred to in paragraph
(4) (c) for the evaluation reports (in this subregulation called the
relevant reports) are:
(a) that the relevant reports were made
respectively by a competent regulatory authority in each of the 2 countries
referred to in paragraph (4) (b); and
(b) that neither of the relevant reports is,
wholly or in part, based on:
(i) the other relevant report; or
(ii) any other evaluation report that
is a report on which the other relevant report was based; or
(iii) any other evaluation report that
is based on another report (being an evaluation report) if the other relevant
report was based on that other report or any evaluation report that was based
on that other report.
(6) In this regulation:
acceptable country means a country that the
Minister has notified in the Gazette as an acceptable country for the
purposes of this regulation.
evaluation report does not include a report
prepared by or on behalf of the applicant or sponsor and submitted to a
regulatory authority in connection with an application for registration of, or
variation of information in a register about, therapeutic goods.
based on, in relation to an evaluation
report, includes compiled by reference to or in reliance on.
relevant period, in relation to an acceptable
country, means the period stated in relation to the country in a notice under
the definition of acceptable country.
16D Periods
within which certain applications must be decided
(1) Subject to paragraph (4) (d), this regulation
applies to an application (other than an application to which regulation 16F
applies) concerning an evaluation of a medicine that is a product of a kind
specified in Part 1 of Schedule 10 if the application:
(a) is received by the Secretary on or after 1
February 1992; and
(b) asks the Secretary under subsection
9D (3) of the Act to vary the entry of the medicine in the Register.
(2) A reference in this regulation to a period, in
relation to an evaluation of an application to which this regulation applies, is
a reference to the period that commences on the day on which the Secretary
sends a notification to the applicant under regulation 16B that indicates
acceptance of the application.
(3) An application to which this regulation applies must
be decided, and notification given to the applicant, within whichever of the
following periods applies:
(a) if the application satisfies the conditions
stated in subregulation (4) — 175 working days;
(b) in any other case — 255 working days.
(4) The conditions referred to in paragraph (3) (a)
are:
(a) that the application relates to a medicine
that, in each of 2 acceptable countries, has been approved for general
marketing;
(b) that the formulation, directions for use and
indications of the medicine are identical to those evaluated and approved for
marketing in those 2 countries; and
(c) that the Secretary has 2 evaluation reports
on the medicine that satisfy the requirements of subregulation (5); and
(d) that the application is received by the
Secretary on or after 1 September 1992.
(5) The requirements referred to in paragraph
(4) (c) for the evaluation reports (in this subregulation called the
relevant reports) are:
(a) that the relevant reports were made
respectively by a competent regulatory authority in each of the 2 countries
referred to in paragraph (4) (b); and
(b) that neither of the relevant reports is,
wholly or in part, based on:
(i) the other relevant report; or
(ii) any other evaluation report that
is a report on which the other relevant report was based; or
(iii) any other evaluation report that
is based on another report (being an evaluation report) if the other relevant
report was based on that other report or any evaluation report that was based
on that other report.
(6) The definitions in subregulation 16C (6) apply
to this regulation.
16E Failure
to decide an application within specified time
The failure to decide, within the relevant time
stated in paragraph 16D (3) (a) or (b), an application to which
regulation 16D applies does not make the Commonwealth, the Secretary or a
delegate of the Secretary liable to a person for loss, damage or injury, of any
kind, that is caused by or arises out of the failure.
16F Applications under subsection 9D (3)
of the Act — periods within which certain decisions must be made
(1) Subject to subregulation (2), this regulation
applies to an application, in relation to a medicine included in the Register
that is a product of a kind specified in Part 1 of Schedule 10, to vary
the information in the Register concerning the medicine in relation to:
(a) the specifications for the active
ingredient, finished product or excipients; or
(b) the method of manufacture of the active
ingredient; or
(c) the manufacturing procedure for the finished
product; or
(d) the site of manufacture of the active
ingredient or the finished product; or
(e) the shelf life; or
(f) the storage conditions; or
(g) the labelling; or
(h) any other particular that is not a
particular mentioned in subsection 16 (1) of the Act.
(2) This regulation does not apply to an application
that:
(a) in the opinion of the Secretary, needs to be
supported by clinical, pre‑clinical or bio‑equivalence data; or
(b) applies for a variation of therapeutic goods
that will make the therapeutic goods as varied separate and distinct
therapeutic goods because of subsection 16 (1) of the Act.
(3) In the case of an application to which this
regulation applies, the Secretary must:
(a) decide the application and notify the
applicant of the decision; or
(b) raise an objection concerning the
application;
within the period of 45 working days that commences on the day on
which the application is lodged and the evaluation fee for the application is
paid or, if lodgment and payment occur on different days, on the later of those
days.
(4) If the Secretary raises an objection concerning an
application to which this regulation applies, he or she must decide the
application and notify the applicant of the decision within the period of 30
working days that commences on the day on which the Secretary receives the
applicant’s response to the objection.
(5) If the Secretary does not comply with subregulation
(3) and, if applicable, subregulation (4) in the case of an application to
which this regulation applies, the Secretary is taken to have approved the
application.
16G Shorter
evaluation period in certain cases
(1) Subject to subregulation (2), this regulation
applies to an application to register a medicine that is a product of a kind
specified in Part 1 of Schedule 10 if:
(a) the application is received by the Secretary
on or after 1 July 1992; and
(b) the application requires an evaluation under
section 25 of the Act; and
(c) the sponsor of the application holds a
registration for a medicine that contains the same active ingredient or active
ingredients, in the same dosage form and strength as stated in the application.
(2) This regulation does not apply to an application
that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical
or bio‑equivalence data.
(3) The provisions of subregulations 16F (3), (4) and
(5) apply to applications to which this regulation applies as if those
applications were applications to which regulation 16F applies.
Division 2 Applications for evaluation of substances
16GA Evaluation
other than evaluation under subsection 9D (1), (2) or (3) or 24 (1)
of the Act
(1) At the request of a person, and on payment of the
prescribed fee, the Department may evaluate data submitted by the person
concerning the following substances:
(a) a substance that is not an ingredient in
listed goods or registered goods for supply in Australia, but that may be an
ingredient in goods for which an application may be made for entry in the
Register as listed goods or registered goods for supply in Australia;
(b) a new excipient in therapeutic goods for
dermal application, being a substance not in use as an ingredient in any other
listed goods or registered goods for supply in Australia at the time of
conditional listing or conditional registration of those goods under section 28
of the Act.
(2) An evaluation under this regulation may be made,
although an application under subsection 9D (1), (2) or (3) or section 23
of the Act is not current.
Exemption from fee
(3) No fee is payable for an evaluation under paragraph
(1) (b) if the evaluation is in respect of a new excipient introduced for
use as an ingredient, in compliance with a condition under section 28 of the
Act, imposed before the commencement of this regulation but not earlier than 6
months before the application for evaluation is made.
Part 3B Orphan drugs
16H Orphan drug
(1) A medicine, vaccine or in vivo diagnostic agent is
an orphan drug if it complies with this regulation.
(2) It:
(a) must be intended to treat, prevent or diagnose
a rare disease; or
(b) must not be commercially viable to supply to
treat, prevent or diagnose another disease or condition.
(3) It is not an orphan drug if any of the following
persons or bodies has refused to approve it for use for the disease for a
reason related to the medicine’s safety:
(a) the Secretary;
(b) the Food and Drug Administration of the
United States of America;
(c) the Medicines Control Agency of the United
Kingdom;
(d) the Bureau of Pharmaceutical Assessment of
Canada;
(e) the Medical Products Agency of Sweden;
(f) the Medicines Evaluation Board of the
Netherlands;
(g) the European Agency for the Evaluation of
Medicinal Products.
(4) It is not an orphan drug if it has been registered
for use for the disease or condition before 1 January 1998.
(5) However, it may be registered before 1 January 1998
for another use or indication.
16I Application for orphan drug designation
(1) The sponsor of an orphan drug may apply to the
Secretary for the medicine to be designated as an orphan drug.
(2) The application must be made using an application
form approved by the Secretary.
(3) The application must show why the medicine is an
orphan drug.
(4) For a vaccine or in vivo diagnostic agent, the
application must also state that the vaccine or agent will be administered in
Australia to not more than 2,000 people in each year after it is registered for
use for the disease or condition.
Note There is no fee for making the
application: see subregulation 45 (12).
16J Orphan drug designation
(1) The Secretary must consider the application.
(2) The Secretary must designate the medicine, in
writing, as an orphan drug if the Secretary is satisfied that the statements
made in the application are correct.
(3) The Secretary must refuse to designate the medicine
as an orphan drug if the Secretary is not satisfied that all of the statements
made in the application are correct.
(4) The Secretary must tell the applicant in writing, as
soon as practicable after making the decision, whether the medicine has been
designated.
Note There is no fee for making the
Secretary’s decision: see subregulation 45 (12).
(5) If the Secretary designates the medicine, the
Secretary must publish a notice in the Gazette, as soon as practicable
after making the decision, giving the following information:
(a) the sponsor’s name;
(b) the medicine’s dose form and indication;
(c) a statement that the medicine is a
designated orphan drug.
Part 4 Licensing of manufacturers
17 Exempt
goods for the purposes of subsection 34 (1) of the Act
(1) For the purposes of subsection 34 (1) of the
Act, the therapeutic goods specified in Schedule 7 are exempt from the
operation of Part 3‑3 of the Act unless the goods are supplied as
pharmaceutical benefits.
(2) If:
(a) therapeutic goods that are exempt from the
operation of Part 3‑3 of the Act cease to be exempt; and
(b) before the day on which the goods cease to be
exempt, each person who carries out a step in the manufacture of the goods
applies for a licence authorising the person to carry out the step on premises
referred to in the application;
the goods produced by those persons carrying out the steps on those
premises are taken to be exempt from the operation of that Part until each
application is determined.
18 Exempt
Persons
For the purposes of subsection 34 (2) of the
Act, the persons specified in column 2 of an item in Schedule 8 are exempt from
the operation of Part 3‑3 of the Act in relation to the manufacture, or
the steps in the manufacture, of the therapeutic goods specified in column 3 of
that item.
19 Requirements for licence holders
For the purposes of section 40 of the Act, it is a
condition of each licence that the licence holder must give the Secretary, at
the time of payment of the annual licensing charge in respect of the licence:
(a) if the Secretary so requests — details
of therapeutic goods manufactured by or on behalf of the licence holder during
the period of 12 months immediately preceding the date on which the payment of
the charge is due; and
(b) the name, qualifications and details of the
relevant experience of any person nominated by the licence holder as having
control of:
(i) the production of the goods; and
(ii) the quality control measures that
are to be employed in the manufacture of the goods.
20 Conditions
of licences
For the purposes of section 40 of the Act, the
following are conditions to which each licence is subject:
(a) a copy of the licence and of any document
issued by the Secretary imposing or amending the conditions applicable to that
licence are to be displayed publicly at the premises specified in the licence;
(b) unless the contrary intention appears in the
licence or in documents issued by the Secretary imposing or amending the
conditions applicable to the licence, the licence holder must:
(i) keep records showing:
(A) the materials used in
the manufacture of the goods, the supplier and quantities of the materials used
and details of the tests performed on those materials; and
(B) the procedures and
controls employed in the manufacture of the goods, including the results of
tests carried out during the processing of the goods; and
(C) details of the tests
performed on the goods and the results of those tests; and
(D) the stability studies
(if any) that validate the recommended shelf life and appropriate storage
conditions of the goods; and
(ii) where the goods to which the
licence relates are produced in identifiable batches:
(A) assign a batch number to
each batch of the goods; and
(B) if it is not unreasonable
in the circumstances — retain at those premises, for not less than 12
months after the expiry date of the goods or, if there is no expiry date, for
not less than 6 years after completion of manufacture of the goods, a sample of
each batch of the finished goods; and
(iii) retain those records at the
licensed premises for at least 12 months after the expiry date of the goods to
which they relate or, if there is no expiry date, for not less than 6 years
after completion of manufacture of the goods; and
(iv) ensure that the persons nominated
by the licence holder as having control of the production of the goods and of
the quality control measures that are to be employed in the manufacture of the
goods maintain that control;
(c) the licence holder must comply with the
provisions of Part 5 in relation to the taking of samples by authorised
officers.
21 Persons
having control of production etc to be named
If:
(a) an applicant for a licence to manufacture
therapeutic goods nominates a person as having control of the production of
goods or the quality control measures in respect of the manufacture of the
goods; and
(b) the licence is granted; and
(c) the applicant wishes to replace the
nominated person with another person;
then it is a condition of the licence that the licence holder must
inform the Secretary as soon as practicable of the name, qualifications and
experience of that other person.
22 Transfer
of licences
(1) If a person who was the holder of a licence dies,
the legal personal representative of the dead person:
(a) is taken to be the holder of the licence;
and
(b) must notify the Secretary, in writing, of the
death not later than 3 months after it occurred.
(2) If a person who is the holder of a licence becomes
bankrupt, the trustee in bankruptcy of the estate of the bankrupt:
(a) is taken to be the holder of the licence;
and
(b) must notify the Secretary, in writing, of the
bankruptcy not later than 3 months after the person became bankrupt.
(3) If a body corporate that is the holder of a licence
is being wound up, the liquidator of the body corporate:
(a) is taken to be the holder of the licence;
and
(b) must, not later than 3 months after the body
corporate is wound up, notify the Secretary, in writing, of the winding up.
(4) If:
(a) a person agrees to dispose of a business
relating to the manufacture, distribution or sale of therapeutic goods; and
(b) it is agreed that the disposal of that
business is to include a transfer of a licence held by that person;
then:
(c) the person who acquires that business is
taken to be the holder of the licence; and
(d) that person must, not later than 3 months
after the transfer, notify the Secretary that the person has, by reason of that
agreement, become an applicant for the licence.
(4A) If a person who is the holder of a licence:
(a) changes his, her or its name; or
(b) being a corporation, amalgamates with another
corporation under a name that is different from the name of the holder of the
licence;
the person must give notice in writing to the Secretary of the new
name of the person, and the circumstance giving rise to it, within
3 months after the occurrence of the circumstance.
(4B) The licence has effect as if it had been granted to
the holder in the holder’s new name.
(5) When a person notifies the Secretary of an event
referred to in paragraph (1) (b), (2) (b), (3) (b), (4) (d)
or (4A) (a) or (b), the person must send to the Secretary sufficient
documentary evidence to establish the matter asserted in the notification.
(6) When a person is taken to be the holder of a licence
in accordance with this regulation, the Secretary may regard the person as an
applicant for the licence and may deal with the notification referred to in
paragraph (1) (b), (2) (b), (3) (b), (4) (d) or
(4A) (a) or (b) as if it were an application for a licence.
(7) In spite of subregulation (6), a person who is
regarded as an applicant for a licence because of the operation of that
subsection may continue to manufacture therapeutic goods under the original
licence until the application is determined.
(8) If, at any time, the Secretary becomes aware that he
or she has not been informed in accordance with this regulation of an event
referred to in paragraph (1) (b), (2) (b), (3) (b), (4) (d)
or (4A) (a) or (b), the Secretary may cancel the licence to which the
event relates.
Part 5 Examination, testing and analysis of goods
23 Interpretation
(1) In this Part, unless the contrary intention appears:
relevant test:
(a) in relation to the analysis of therapeutic
goods (other than medical devices), means a test that, under subregulation
28 (1), is a relevant test for the purpose of determining whether goods of
a class in which the first‑mentioned goods are included are goods that
conform with a standard applicable to the goods; and
(b) in relation to the analysis of a medical
device, means a test that, under subregulation 28 (2), is a relevant test
for the purpose of determining whether a medical device of that kind complies
with the applicable provisions of the essential principles.
responsible analyst, in relation to the
analysis of a sample of therapeutic goods, means an official analyst who is
nominated as a responsible analyst for the sample under paragraph
25 (3) (c).
samples officer means an officer of the
Department performing duties under the direction of an official analyst.
(2) For this Part, a
sample of therapeutic goods is appropriately fastened and sealed if the sample
is fastened and sealed:
(a) in a vessel
or package that is marked with the name and address of:
(i) the person from whom the sample
was taken; or
(ii) for a sample delivered under
subsection 28 (5A) or 41FN (2) of the Act — the sponsor of the
goods; and
(b) so as to prevent the opening of the vessel or
package, and the removal of the name and address, without breaking the seal.
24 Authorised officer — powers and
duties
(1) An authorised officer may, during normal business
hours:
(a) for the purpose of exercising the powers and
performing the duties of an authorised officer under this regulation, enter the
premises of a licence holder, manufacturer in respect of whom a conformity
assessment certificate has been issued, or wholesaler on which therapeutic
goods are kept for supply; and
(b) inspect the place at which those goods are
kept; and
(c) take samples of those goods; and
(d) ask the owner of therapeutic goods, or the
person apparently in charge of those goods, for information relevant to the
manufacture and testing of those goods.
(2) If the entry of goods in the Register is subject to
the condition that the sponsor of the goods comply with this regulation, the
powers of an authorised officer referred to in subregulation (1) extend to the
sponsor as if the sponsor were a licence holder or a manufacturer in respect of
whom a conformity assessment certificate has been issued.
25 Official
analysts
(1) The Secretary may, in writing, appoint a person who
has appropriate qualifications and experience to be an official analyst for the
purposes of these Regulations.
(2) The Secretary is to maintain a register of the names
of official analysts and is to cause those names to be published in the Gazette
from time to time.
(3) In addition to the other powers and functions of an
official analyst, an official analyst may:
(a) ask an authorised officer to take samples of
therapeutic goods; and
(b) determine the tests that are to be performed
on a sample taken under paragraph (a) or delivered under subsection
28 (5A) or 41FN (2) of the Act; and
(c) nominate an official analyst to be the
responsible analyst for a sample taken under paragraph (a) or delivered
under subsection 28 (5A) or 41FN (2) of the Act.
26 Taking of samples for testing
(1) When an authorised officer takes a sample of
therapeutic goods (other than a further sample taken under the circumstances
described in subregulation 30 (6)), the authorised officer:
(a) must notify the person from whom the sample
was taken that the authorised officer is going to send the sample to a
laboratory operated by the Department for analysis; and
(b) must give the person from whom the sample was
taken a notice setting out details of the goods taken and, if the person from
whom the sample was taken was not the sponsor of the goods, send a copy of that
notice to the sponsor of the goods; and
(c) must forward the whole or part of the sample
to the relevant laboratory.
(2) An authorised officer
must ensure that any sample of goods taken (including further samples taken
under the circumstances described in subregulation 30 (6)) is:
(a) appropriately packaged, fastened and sealed;
and
(b) stored and transported in accordance with the
instructions (if any) specified on the label of the goods.
26A Receiving samples for testing
(1) When a sample of
therapeutic goods is delivered under subsection 28 (5A) or 41FN (2)
of the Act, the Secretary must as soon as practicable:
(a) determine whether the sample is
appropriately packaged, fastened and sealed; and
(b) do either of
the following:
(i) if the sample is appropriately
packaged, fastened and sealed — send the sample, in the form in which it
was received, to the relevant laboratory operated by the Department for
analysis;
(ii) if the sample is not appropriately
packaged, fastened and sealed — return the sample to the sponsor of the
goods, with a statement explaining in what way the sample is not appropriately
packaged, fastened or sealed.
(2) In complying with subregulation (1), the
Secretary must ensure that the sample is stored and transported in accordance
with the instructions (if any) specified on the label of the goods.
27 Examination
and testing of sample
(1) A samples officer must, as soon as practicable after
receiving a sample of goods at a laboratory operated by the Department:
(a) determine whether the sample is
appropriately packaged, fastened and sealed; and
(b) if the sample is appropriately packaged,
fastened and sealed — store the sample under the officer’s control and
under secure conditions that are appropriate to the kind of goods.
(2) The responsible analyst must, as soon as practicable,
collect the sample from the samples officer and arrange for:
(a) an analysis of the sample by relevant tests
to the extent the analyst considers necessary to establish:
(i) the quantity and quality of the
goods comprising the sample; and
(ii) any other matter relevant to
determining whether:
(A) for goods other than
medical devices — the goods from which the sample was taken conform with
any standard applicable to the goods and any conditions relating to matters
mentioned in paragraph 28 (2) (d) of the Act; and
(B) for medical
devices — the goods from which the sample was taken comply with the
applicable provisions of the essential principles and any conditions relating
to matters mentioned in paragraph 41FO (2) (d) of the Act; and
(b) an examination of the goods, the label (if
any) relating to the goods and the packaging of the goods, to determine whether
the goods comply with the labelling, packaging and other requirements
(including requirements relating to advertising) applicable to the goods.
28 Relevant
tests
(1) Each of the following is a relevant test for
determining whether particular therapeutic goods (other than medical devices)
are goods that conform with a standard applicable to the goods:
(a) a test specified by the Minister in an order
under section 10 of the Act for those goods in relation to that standard;
and
(b) a test specified in a monograph in the
British Pharmacopoeia in relation to that standard if:
(i) those goods are for use in humans;
and
(ii) the Minister has not specified a
test in an order under section 10 of the Act for those goods in relation to
that standard; and
(c) a test specified in a monograph in the
British Pharmacopoeia (Veterinary) in relation to that standard if:
(i) those goods are for veterinary
use; and
(ii) the Minister has not specified a
test in an order under section 10 of the Act for those goods in relation to
that standard; and
(d) a test accepted for the purposes of
registration of the goods under Part 3‑2 of the Act; and
(e) any other suitable test that the Secretary
requires to be carried out in respect of those goods in relation to that
standard.
(2) Each of the following is a relevant test for
determining whether a particular kind of medical device complies with the
applicable provisions of the essential principles:
(a) a test specified in a medical device
standard or conformity assessment standard for the kind of device;
(b) a test accepted for the purpose of issuing a
conformity assessment certificate in respect of the kind of device;
(c) a test required under paragraph
41FO (2) (d) of the Act as a condition of inclusion of the kind of
device in the Register;
(d) any other suitable test that the Secretary
requires to be carried out in respect of the kind of device for the purpose of demonstrating
compliance with the applicable provisions of the essential principles.
29 Certificate
of official analyst
(1) The responsible analyst must send to the sponsor of
the goods a certificate signed by the analyst setting out the results of the examination
and analysis.
(2) The responsible analyst must send a copy of the
certificate, signed by the analyst, to:
(a) the Secretary; and
(b) if the sample was taken under subregulation
25 (3) — the person from whom the sample was taken, if that person is
not the sponsor of the goods.
(3) The certificate and copies of the certificate of the
official analyst must be sent to the persons referred to in subregulations (1)
and (2) within a reasonable time of the completion of the analysis.
(4) If the certificate referred to in subregulation (1)
states:
(a) for relevant goods other than medical
devices — that the goods do not conform with a specified standard or
comply with a requirement that is applicable to the goods under regulation 27;
or
(b) for medical
devices — that the goods do not comply with the applicable provisions of
the essential principles or a requirement that is applicable to the goods under
regulation 27;
the certificate, and the copy of it referred to in
subregulation (2), must be accompanied by a notice that complies with
subregulation (4A).
(4A) For subregulation
(4), the notice must:
(a) state that the person to whom the
certificate or copy is sent may ask for the results of the analysis referred to
in the certificate to be reviewed in accordance with regulation 30; and
(b) specify the time within which a request for a
review of the results may be made; and
(c) state that the person may ask for an
extension of that time if it is not reasonable to expect the person to comply
with regulation 30 within the specified time.
(5) In proceedings under the Act or these Regulations, a
certificate of an official analyst issued under subregulation (1), or a copy of
that certificate, is, in the absence of evidence to the contrary, conclusive
proof of the matters set out or stated in it.
(6) A document purporting to be:
(a) a certificate of an official analyst issued
under subregulation (1); or
(b) a copy of that certificate;
and purporting to be signed by an official analyst is, in the
absence of evidence to the contrary, to be taken to be the certificate or a
copy of the certificate and to have been issued under subregulation (1) or (2),
as the case requires.
30 Review
of findings of official analyst
(1) A person:
(a) to whom a certificate, setting out the
results of an examination and analysis of goods, is issued under subregulation
29 (1); and
(b) who sends to the Secretary evidence in
writing establishing that the goods do conform with the specified standard or
comply with an applicable requirement, or, for medical devices, do comply with
the applicable provisions of the essential principles or an applicable
requirement;
may ask for the results of the analysis to be reviewed.
(2) A request for review of the results of the analysis
is to be made not later than 21 days after the person receives the certificate,
or the copy of the certificate, as the case may be.
(3) The Secretary must extend the period of 21 days if
it is not reasonable to expect the person to provide the evidence within the
period referred to in subregulation (2).
(4) A person is not to be regarded as having sent the
Secretary evidence establishing that goods conform with a specified standard or
comply with an applicable requirement, or, for medical devices, comply with the
applicable provisions of the essential principles or an applicable requirement,
unless that person has sent to the Secretary a certificate of an analyst who
has appropriate qualifications and experience setting out:
(a) a statement that the analyst has analysed a
part of the same sample, or a similar sample from the same batch (if any), of
those goods; and
(b) the results of that analysis; and
(c) details of the tests used in the analysis.
(5) If the certificate referred to in subregulation (4)
shows that an analysis of goods for the purpose of establishing that the goods
conform with a specified standard or comply with an applicable requirement, or,
for medical devices, comply with the applicable provisions of the essential
principles or an applicable requirement, was carried out in accordance with the
relevant tests in relation to the goods, subregulation (6) applies to those
goods.
(6) Unless the results of the analysis of a sample of
goods to which this subregulation applies, or other information available to
the Secretary in relation to those goods, shows lack of homogeneity in the
sample, the Secretary, at the request of the sponsor of the goods, must direct:
(a) if part of the sample remains
unimpaired — the official analyst to send so much of the sample as remains
unimpaired; or
(b) if no part of the sample remains
unimpaired — that a further sample be taken by an authorised officer from
the same batch as the original sample and that that further sample be sent;
to an analyst agreed upon by the person who requested the review
and the official analyst, or, in the absence of agreement, to an analyst
nominated by the Secretary.
(7) If a sample is forwarded to an analyst referred to
in subregulation (6), the analyst is to:
(a) analyse the sample of the goods in
accordance with any relevant tests;
(b) send to the Secretary a certificate, signed
by the analyst, setting out the results of the analysis; and
(c) send a copy of that certificate, signed by
the analyst to the sponsor of the goods.
(8) A certificate under regulation 29 setting out the
results of the analysis of a sample of goods ceases to have effect when the
Secretary receives the certificate in relation to those goods under
subregulation (7).
(9) If the findings of the official analyst are upheld,
the sponsor must pay any charges payable to the analyst referred to in
subregulation (6) in respect of the analysis of the sample.
(10) In proceedings under the Act or these Regulations, a
certificate of an analyst issued under subregulation (7) or a copy of that
certificate is, in the absence of evidence to the contrary, conclusive proof of
the matters stated in it.
(11) A document purporting
to be:
(a) a certificate of an analyst issued under
subregulation (7); or
(b) a copy of that certificate, and purporting to
be signed by the analyst;
is, in the absence of evidence to the contrary, to be regarded as
the certificate, or a copy of the certificate, and to have been issued under
that subregulation.
31 Payment
for samples
(1) If a sample of therapeutic goods is taken by an
authorised officer, the Commonwealth is liable to pay the owner of the goods
from which the sample was taken an amount equal to the value of any part of the
sample removed by the authorised officer.
(1A) If a sample of therapeutic goods delivered under
subsection 28 (5A) or 41FN (2) of the Act is sent to a
laboratory for analysis, the Commonwealth is liable to pay to the person in
relation to whom the goods are entered on the Register an amount equal to the
value of the sample.
(2) The amount the Commonwealth is liable to pay is to
be worked out on the basis of the market value of the sample when the sample
was taken by the authorised officer or delivered under subsection 28 (5A)
or 41FN (2) of the Act.
32 Offences
relating to analysis etc
(1) A person must not:
(a) molest, obstruct or try to intimidate or
influence an authorised officer in the execution of his or her powers or the
performance of his or her duties under these Regulations; or
(b) on being asked by an authorised officer,
fail:
(i) to show the authorised officer the
place where any therapeutic goods are kept; or
(ii) to admit the authorised officer to
a place where therapeutic goods are kept; or
(iii) to show the authorised officer,
or let the authorised officer inspect, therapeutic goods kept by the person; or
(iv) to allow a sample of therapeutic
goods to be taken in accordance with these Regulations; or
(v) to give an authorised officer
information required by the authorised officer, being information relevant to
the manufacture and testing of therapeutic goods that the person is able to
provide; or
(vi) to assist the authorised officer in
the execution of his or her powers or the performance of his or her duties
under these Regulations; or
(c) on being asked by an official analyst, fail
to give any information required by the official analyst, being information
relevant to the testing of therapeutic goods, that that person is able to
provide.
Penalty: 10 penalty units.
(1A) For the purposes of an offence under
paragraph (1) (a), strict liability applies to the physical element
that the duties mentioned in that paragraph are duties under these Regulations.
Note For strict liability,
see section 6.1 of the Criminal Code.
(1B) An offence under paragraph (1) (b)
or (c) is an offence of strict liability.
Note For strict liability,
see section 6.1 of the Criminal Code.
(1C) It is a defence to a prosecution under
paragraph (1) (b) or (c) if the person has a reasonable excuse.
Note A defendant bears an evidential
burden in relation to the matter mentioned in subregulation (1C) (see
section 13.3 of the Criminal Code).
(2) It is a reasonable excuse for a person to fail to
comply with a request for information under paragraph (1) (b) or (c) if
compliance with that request would tend to incriminate that person.
33 Identity
cards
(1) The Secretary is to ensure that each authorised
officer is issued with an identity card that incorporates a recent photograph
of the person.
(2) Where the authorised officer enters premises in the
course of his or her duties under this Part, the authorised officer must, if
requested to do so by any person at those premises, produce his or her identity
card for inspection by that person.
(3) When a person ceases to be an authorised officer,
the person must, as soon as practicable after so ceasing, return the person’s
identity card to the Secretary.
Penalty: 1 penalty unit.
(4) An offence under
subregulation (3) is an offence of strict liability.
Note For strict liability,
see section 6.1 of the Criminal Code.
Part 6 Committees
Division 1 Therapeutic Goods Committee, Medical Devices Evaluation
Committee and Australian Drug Evaluation Committee
34 Therapeutic
Goods Committee
(1) The Therapeutic Goods Committee is established.
(2) The Committee’s functions are:
(a) to consider:
(i) the adoption of standards for
therapeutic goods; and
(ii) matters relating to standards for
therapeutic goods; and
(iii) requirements for labelling and
packaging of therapeutic goods; and
(iv) principles to be observed in the
manufacture of therapeutic goods for human use; and
(v) matters relating to the adequacy of
a medical device standard in so far as it relates to a part or parts of the
essential principles; and
(vi) matters relating to the adequacy of
a conformity assessment standard in so far as it relates to a part or parts of
the conformity assessment procedures;
and advise the Minister of the results of
its consideration; and
(b) to advise the Minister on the likely impact
that adoption of a proposed standard would have on Australian domestic and
international trade; and
(c) to consider a matter that is referred to the
Committee by the Minister and to advise the Minister of the results of its
consideration.
(3) The Committee must:
(a) give to the Minister the reasons for any
advice of the Committee; and
(b) when considering a matter to which paragraph
(2) (a) applies, have regard to:
(i) the desirability of adopting
standards of the British Pharmacopoeia and other recognised international
standards for therapeutic goods in the interests of international harmonisation
of therapeutic goods standards; and
(ii) whether the application of those
standards to Australian conditions is appropriate.
(4) The Minister must appoint in writing 11 persons to
the Committee in accordance with subregulations (4A), (4B) and (4C).
(4A) The Committee must comprise the following persons:
(a) a person who is nominated to the Minister in
writing by a body that represents, or a combination of bodies that together
represent, the interests of Australian manufacturers of prescription medicine
products;
(b) a person who is nominated to the Minister in
writing by a body that represents, or a combination of bodies that together
represent, the interests of Australian manufacturers of non‑prescription
medicine products;
(c) a person who is nominated to the Minister in
writing by a body that represents, or a combination of bodies that together
represent, the interests of Australian manufacturers of alternative medicines;
(d) a person who is nominated to the Minister in
writing by a body that represents, or a combination of bodies that together
represent, the interests of Australian manufacturers of medical devices and
other therapeutic goods;
(e) a person who is nominated to the Minister in
writing by a body that represents, or a combination of bodies that together
represent, the interests of consumers of health services;
(f) a person with expertise in microbiology and
virology;
(g) a person with expertise in biomedical
engineering;
(h) a person with expertise in the biological
safety of biomaterials;
(i) a person with expertise in biotechnology;
(j) a person with expertise in pharmaceutical
sciences;
(k) a member of the Health and Food Standards
Advisory Committee of Standards Australia.
(4B) At least 1 of the persons appointed to the Committee
must be a medical practitioner.
(4C) At least 1 of the persons to whom paragraphs
(4A) (f), (g), (h), (i), (j) and (k) refer must be able to represent the
interests of consumers of health services.
(4D) The chairperson of the Committee may invite a person
who is nominated in writing by the National Registration Authority for
Agricultural and Veterinary Chemicals to attend a meeting at which a matter
that is relevant to the function of the Authority is to be discussed.
(5) The Minister is to appoint, in writing, a member of
the Committee to be its chairperson.
(6) The Committee may appoint sub‑committees,
consisting of members of the Committee and other persons to inquire into, and
report to the Committee on, any matter that is within the functions of the
Committee.
35 Medical
Devices Evaluation Committee
(1) The Medical Devices Evaluation Committee is
established.
(2) The functions of the Committee are:
(a) to give medical and scientific advice to the
Minister or the Secretary in relation to any medical device that the Minister
or the Secretary refers to it; and
(b) to give medical and scientific advice to the
Minister or the Secretary in relation to any medicines that the Minister or the
Secretary refers to it; and
(c) to give medical and scientific advice to the
Minister or the Secretary in relation to any other therapeutic goods that the
Minister or the Secretary refers to it; and
(d) to give advice to the Minister or the
Secretary about the importation into, exportation from, and manufacture,
distribution and supply in Australia, of therapeutic goods that have been
assessed by the Committee; and
(e) to give advice that has been given to the
Minister or the Secretary under paragraph (d) to persons or bodies as the
Minister may direct.
(3) Membership of the Committee consists of:
(a) at least 8, and not more than 12, core
members; and
(b) at least 8, and not more than 20, associate
members.
(4) The Minister must appoint to the Committee:
(a) as core members:
(i) at least 3 persons, each of whom
is a medical practitioner eminent in the medical profession and at least 2 of
whom are specialists in clinical medicine; and
(ii) at least 1 person with expertise
in consumer issues; and
(iii) at least 1 person with expertise
in industry issues; and
(iv) at least 1 person who is a
biomedical engineer, or who holds a university degree in biomedical
engineering; and
(v) at least 1 person with expertise in
biomaterials, or who holds a university degree in biomaterial science; and
(b) as associate members:
(i) at least 1 person who is a medical
practitioner eminent in the medical profession; and
(ii) at least 1 person who is a
biomedical engineer, or who holds a university degree in biomedical
engineering; and
(iii) at least 1 person with expertise
in biomaterials, or who holds a university degree in biomaterial science.
(5) The Minister must appoint, in writing, a member of
the Committee to be its chairperson.
(6) The Committee may appoint sub‑committees,
consisting of members of the Committee and other persons, to inquire into, and
report to the Committee on, any matter within the Committee’s functions.
36 Australian
Drug Evaluation Committee
(1) The Australian Drug Evaluation Committee is
established.
(2) The functions of the
Committee are:
(a) to make medical and scientific evaluations
of any medicines that the Minister or the Secretary refers to it for
evaluation; and
(b) to make medical and scientific evaluations of
other medicines if, in the opinion of the Committee, it is desirable that it
should do so; and
(c) to make medical and scientific evaluations
of such medical devices and other therapeutic goods that the Minister or the
Secretary refers to it for evaluation; and
(d) to give advice to the Minister or the
Secretary about the importation into, the exportation from and the manufacture
and distribution within, Australia of therapeutic goods that have been the
subject of evaluation by the Committee; and
(e) to give advice that has been given to the
Minister or the Secretary under paragraph (d) to persons or bodies as the
Minister may direct.
(3) Membership of the Committee consists of:
(a) 6 or 7 core members; and
(b) at least 10, and not more than 20, associate
members.
(4) The Minister must appoint to the Committee:
(a) as core members:
(i) at least 3 persons, each of whom
is a medical practitioner eminent in the medical profession and at least 2 of
whom are specialists in clinical medicine; and
(ii) at least 1 person who is a
pharmacologist, or who holds a university degree in science or a branch of
science and has specialised in pharmaceutical science; and
(b) as associate members:
(i) at least 1 person who is a
pharmaceutical chemist with recent experience in the manufacturing of
therapeutic goods; and
(ii) at least 1 person who is a
toxicologist; and
(iii) at least 1 person who is a
medical practitioner currently engaged in general practice; and
(iv) other persons, each of whom:
(A) satisfies a criterion
set out in subparagraph (i), (ii) or (iii); or
(B) is a medical
practitioner with specialist qualifications and experience in a field of
medicine that complements the expertise of core members with medical
qualifications.
(5) The Minister is to appoint, in writing, a member of
the Committee to be its chairperson.
(6) The Committee may appoint sub‑committees,
consisting of members of the Committee and other persons, to inquire into, and
report to the Committee on, any matter that is within the functions of the
Committee.
37 Minister
or Secretary may seek further advice
Where a Committee established under this Division
gives advice to the Minister or the Secretary, the Minister or the Secretary
may send a copy of that advice to another Committee established under this
Division and that other Committee may make comments to the Minister or the
Secretary in relation to that advice as it thinks fit.
38 Tenure
of office of members
(1) Subject to subregulation (3), a member of a Committee
established under this Division, other than the Australian Drug Evaluation
Committee, holds office for a term not exceeding 3 years.
(1A) Subject to subregulation (3):
(a) a core member of the Australian Drug
Evaluation Committee holds office for a term not exceeding 3 years; and
(b) an associate member of that Committee holds
office for a term not exceeding 5 years.
(2) Subject to subregulation (2A), a member of a
Committee established under this Division is eligible for re‑appointment.
(2A) A person is not eligible to serve as a member of the
Medical Devices Evaluation Committee or as a core member of the Australian Drug
Evaluation Committee:
(a) for more than 3 consecutive terms; or
(b) for more than 5 terms in all.
(3) The Minister may, for reasons of misbehaviour,
physical or mental incapacity, bankruptcy or imprisonment, by instrument,
remove a member from office at any time.
39 Disclosure
of interest
(1) A member of a Committee established under this
Division who has a direct or indirect pecuniary interest in a matter being
considered or about to be considered at a meeting of the Committee must, as
soon as possible after the relevant facts have come to the member’s knowledge,
disclose the nature of the interest at a meeting of the Committee.
(2) The disclosure is to be recorded in the minutes of
the meeting and the member must not, unless the Committee otherwise determines:
(a) be present during any deliberation of the
Committee with respect to the matter; or
(b) take part in any decision of the Committee
with respect to that matter.
(3) For the purpose of the making of a determination in
relation to the member who has made the disclosure, any member who has a direct
or indirect pecuniary interest in the matter to which the disclosure relates
must not:
(a) be present during any deliberation of the
Committee for the purpose of making the determination; or
(b) take part in the making of the determination
by the Committee.
40 Acting
members
(1) The Minister may appoint a person to act as a member
of a Committee established under this Division:
(a) during a vacancy in the office, whether or
not an appointment has previously been made to the office; or
(b) during any period, or during all periods,
when the holder of the office is absent from duty or from Australia or is, for
any other reason, unable to perform the duties of the office.
(2) A person appointed to act during a vacancy in the
office of a member must not continue so to act for more than 12 months.
(3) Anything done by a person purporting to act as a
member is not invalid merely because:
(a) the occasion for the appointment had not
arisen; or
(b) there is a defect or irregularity in
connection with the person’s appointment; or
(c) the appointment had ceased to have effect; or
(d) the occasion for the person to act had not
arisen or had ceased.
41 Meetings
of Committees
(1) Meetings of a Committee established under this
Division are to be held at the times and places that the chairperson of the
Committee directs.
(2) At a meeting of a Committee:
(a) in the case of the Therapeutic Goods
Committee — 5 members constitute a quorum; and
(b) in the case of the Australian Drug Evaluation
Committee — 6 members, of whom at least 3 are core members,
constitute a quorum; and
(c) in the case of the Medical Devices
Evaluation Committee — 6 members, of whom at least 4 are core members,
constitute a quorum.
(2A) An associate member of the Australian Drug Evaluation
Committee, or the Medical Devices Evaluation Committee, is eligible to attend a
meeting of the relevant Committee only at the invitation of the chairperson of
that Committee.
(2B) The Australian Drug Evaluation Committee may delegate
to the chairperson of the Committee any function of the Committee.
(2C) The Medical Devices Evaluation Committee may delegate
to the chairperson of the Committee any function of the Committee.
(3) The chairperson of a Committee is to preside at all
meetings of the Committee at which he or she is present.
(4) If the chairperson of a Committee is absent from a
meeting of a Committee, the members of the Committee present are to appoint one
of their number to preside at that meeting.
(5) A question arising at a meeting of a Committee is to
be determined by a majority of votes of the members present and voting.
(6) The member presiding at a meeting of a Committee has
a deliberative vote and, in the event of an equality of votes, also has a
casting vote.
42 Effect
of vacancy on Committees
The exercise of a power or the performance of a
function of a Committee established under this Division is not affected by a
vacancy or vacancies in the membership of that Committee.
Division 2 Therapeutic Goods Advertising Code Council
42A Therapeutic Goods Advertising Code Council
A committee, to be known as the Therapeutic Goods
Advertising Code Council, is established.
42B Functions
of the Council
(1) The Council’s functions are:
(a) to consider requirements for the advertising
of therapeutic goods and changes to the Therapeutic Goods Advertising Code, to
accept submissions for this purpose and to advise the Minister accordingly; and
(b) to make recommendations to the Minister for
achieving greater uniformity in approval processes and standards for
advertising therapeutic goods in specified media and broadcast media; and
(c) to make recommendations to the Minister
about requests for review of a decision of the Secretary under regulation 5G;
and
(d) to consider matters raised at Council
meetings by Council members or observers to the Council and advise the Minister
accordingly; and
(e) to advise the Minister on any matter
referred to the Council by the Minister or Secretary; and
(f) any other function conferred on the Council
by these Regulations.
(2) The Council may, with the approval of the Minister,
appoint sub‑committees of its members to inquire into, and report on, any
matter that is within the functions of the Council.
42C Membership of the Council
(1) The Council is to have 15 members as follows:
(a) 5 manufacturer/supplier members, comprising
1 person nominated by each of the following bodies:
(i) the CHCA;
(ii) the ASMI;
(iii) the Australian Direct Marketing
Association;
(iv) the Direct Selling Association of
Australia Inc;
(v) the Medical Industry Association of
Australia;
(b) 2 advertising industry members, comprising 1
person nominated by each of the following bodies:
(i) the Australian Association of
National Advertisers;
(ii) the Advertising Federation of
Australia;
(c) 2 consumer members, comprising 1 person
nominated by each of the following bodies:
(i) the Australian Consumers
Association;
(ii) the Consumers’ Health Forum;
(d) 3 health care professional members
comprising:
(i) 1 person nominated by the
Australian Traditional Medicines Society; and
(ii) 1
person nominated jointly by the Pharmacy Guild of Australia and the
Pharmaceutical Society of Australia; and
(iii) 1
person nominated by the Royal Australian College of General Practitioners;
(e) 2 members nominated by the Therapeutic Goods
Administration;
(f) 1 member jointly nominated by the Australian
Publishers Bureau and the Outdoor Advertising Association of Australia.
(2) A member of the Council who, before 1 January 1999,
was nominated under paragraph (1) (a) by the NFAA is taken to have
been nominated by the CHCA.
42D Term of office of Council members
(1) A member of the Council holds office for a
term of 2 years from the date of the member’s nomination.
(2) A person cannot hold office for more than 4
consecutive terms.
(3) This regulation applies subject to:
(a) regulation 42F (Resignation); and
(b) regulation 42G (Cessation of membership).
42E Chairperson
of the Council
(1) At the first meeting of the Council, and
afterwards as the occasion arises, the Council must appoint a member of the
Council to be the chairperson of the Council.
(2) The chairperson must be a member nominated by the
Therapeutic Goods Administration.
(3) Unless the chairperson earlier resigns the office,
or ceases to be a member of the Council, the chairperson holds office for
1 year from the date of his or her appointment.
42F Resignation
(1) A member of the Council nominated by a body may
resign as a member by notice in writing to the Council.
(2) The chairperson of the Council may resign the office
of chairperson by notice in writing to the Council.
42G Cessation of membership
A person ceases to be a member of the
Council if:
(a) the person resigns as a member; or
(b) the body who nominated the member nominates
another person to be a member in place of the person first mentioned; or
(c) the member is absent for 2 consecutive
meetings of the Council without leave of the chairperson; or
(d) the Council resolves to remove the member.
42H Alternate
members
(1) A body mentioned in regulation 42C may appoint up to
2 persons who are not members of the Council to each be available to be
the alternate of a member nominated to the Council by that body.
(2) If a member is absent from a meeting of the Council,
the member’s alternate (if any) is entitled to attend the meeting and, when so
attending, is taken to be a member of the Council.
(3) If a person appointed by a body mentioned in
regulation 42C ceases to hold office as a member:
(a) the person who was the person’s alternate
under subregulation (2) immediately before the person ceased to hold office; or
(b) in the absence of an alternate under
paragraph (a), a person who was, under subregulation (1), available to be the
alternate of the person who ceased to hold office;
is entitled to attend meetings of the Council while the office is
vacant and, when so attending, is taken to be a member of the Council.
(3A) The person described in paragraph 3 (a) or (b) is
taken to be the alternate of a person nominated to the vacant office until a
new alternate is appointed.
(4) A person appointed by a body as an alternate may
resign the appointment by notice in writing to the body.
42J Observers
to Council
(1) Each of the bodies mentioned in
subregulation (2) may nominate a person to attend meetings of the Council
as an observer.
(2) For subregulation (1), the bodies are:
(aa) the Australian Competition and Consumer
Commission; and
(b) the Cosmetics, Toiletries and Fragrances
Association of Australia; and
(ca) Medicines Australia; and
(d) Medsafe, a regulatory agency within the New
Zealand Ministry of Health.
(2A) Free TV Australia and Commercial Radio Australia
Limited may jointly nominate a person to attend meetings of the Council as an
observer.
(3) A person nominated as an observer is entitled, until
the nomination is revoked:
(a) to be given the agenda and minutes of
Council meetings, as if the person were a member of the Council; and
(b) by notice in writing to the chairperson
suggest agenda items to be considered by the Council; and
(c) if the person has given notice to the
chairperson that the person intends to attend a meeting of the Council —
to attend the meeting and vote on any question in accordance with regulation
42L.
(4) The chairperson of the Complaints Resolution Panel
may attend meetings of the Council as an observer having the same entitlements
as an observer mentioned in subregulation (3).
42K Quorum
At a meeting of the Council, a quorum
consists of the chairperson and 5 other members of the Council including:
(a) a member nominated by the CHCA or ASMI; and
(b) an advertising industry member; and
(c) a consumer member; and
(d) a health care professional member; and
(e) a member nominated by the Therapeutic Goods
Administration.
42L Meetings
(1) Meetings of the Council are to be held
at the times and places that the chairperson directs.
(2) The chairperson is to preside at meetings of the
Council at which he or she is present.
(3) If the chairperson is absent from a meeting, a
member nominated by the chairperson or, if no member is nominated, a member
chosen by the members of the Council present at the meeting, is to preside.
(4) A question (other than a question mentioned in
subregulation (6)) arising at a meeting of the Council is to be decided by a
majority of the votes of the members and observers present and voting, with the
person presiding at the meeting having a casting vote.
(5) An observer is entitled to vote at a meeting on any
question affecting the interests of the body nominating the observer.
(6) The chairperson is to decide whether a question affects
the interests of the body nominating an observer.
42M Effect
of vacancy
The exercise of a power or the performance of a
function of the Council is not affected by any vacancy in the membership of the
Council.
42N Disclosure
of interest
(1) A member of the Council (including a person
taken to be a member under regulation 42H) who has a direct or indirect
pecuniary interest in a matter being considered or about to be considered at a
meeting of the Council must, as soon as possible after the relevant facts have
come to the member’s knowledge, disclose the nature of the interest at a
meeting of the Council.
(2) The disclosure is to be recorded in the minutes of
the meeting and the member must not, unless the Council otherwise determines:
(a) be present during any deliberation of the
Council with respect to the matter; or
(b) take part in any decision of the Council with
respect to that matter.
(3) For the purpose of the making of a determination in
relation to the member who has made the disclosure, any member who has a direct
or indirect pecuniary interest in the matter to which the disclosure relates
must not:
(a) be present during any deliberation of the
Council for the purpose of making the determination; or
(b) take part in the making of the determination
by the Council.
(4) Subregulations (1), (2) and (3) apply to an observer
to the Council who is intending to take part in any decision of the Council on
a matter as they apply to a member.
42P Procedure
generally
So far as these Regulations do not provide for the
procedure of the Council, the Council may determine its own procedure.
42Q Annual report
Within 3 months after the end of a financial year,
the Council must give the Minister a written report on the operation of the
Council for that financial year.
Division 3 Complaints Resolution Panel
Subdivision 1 General
42R Complaints
Resolution Panel
A committee, to be known as the Complaints
Resolution Panel, is established.
42S Function of the Panel
The function of the Panel is:
(a) to receive and consider complaints about
advertisements and generic information under Subdivision 2; and
(b) to take action and to make recommendations to
the Secretary on the complaints in accordance with that Subdivision.
42T Membership of the Panel
(1) The panel is to have 8 members, as follows:
(a) a chairperson nominated by the Therapeutic
Goods Advertising Code Council;
(b) 2 members, comprising 1 person nominated by
each of the following bodies:
(i) the CHCA;
(ii) the ASMI;
(c) 2 consumer members, comprising 1 person
nominated by each of the following bodies:
(i) the Australian Consumers
Association;
(ii) the Consumers’ Health Forum;
(d) 3 health care professional members
comprising:
(i) 1 person nominated by the
Australian Traditional Medicines Society; and
(ii) 1 person nominated jointly by the
Pharmacy Guild of Australia and the Pharmaceutical Society of Australia; and
(iii) 1 person nominated by the Royal
Australian College of General Practitioners.
(1A) However, the chairperson must nominate an additional
member for a meeting of the Panel at which a complaint about a medical device
or other therapeutic goods is to be considered.
(1B) A person nominated under subregulation (1A) must:
(a) have appropriate expertise and experience;
and
(b) be taken from a list of persons given to the
chairperson by a body that represents, or a combination of bodies that together
represent, the interests of Australian manufacturers, suppliers, exporters and
importers of therapeutic devices.
(2) A person cannot be nominated as a member of the
Panel if the nomination would result in there being more than 4 members of the
Panel who are members of the Therapeutic Goods Advertising Code Council.
(3) A person cannot be nominated as a member of the
Panel if the person is engaged in the process of approving advertisements for
the CHCA or ASMI, under a delegation to the CHCA or ASMI under regulation 5Q.
(4) A member of the Panel who, before 1 January 1999,
was nominated under paragraph (1) (b) by the NFAA is taken to have
been nominated by the CHCA.
42U Term
of office of Panel members
(1) A member of the Panel holds office for a term of
2 years from the date of the member’s nomination.
(2) A person cannot hold office for more than 4
consecutive terms.
(3) This regulation applies subject to
regulation 42V (Cessation of office).
42V Cessation of office
A person ceases to be a member of the Panel if:
(a) the person resigns as a member by notice in
writing to the Panel; or
(b) the body who nominated the member nominates
another person to be a member in place of the person first mentioned; or
(c) the Panel resolves to remove the member.
42W Alternate
members
(1) The chairperson may appoint a person who is not a
member of the panel to be the alternate chairperson of the Panel.
(2) A body mentioned in paragraph 42T (1) (b), (c)
or (d) may appoint up to 2 persons who are not members of the Panel to
each be available to be the alternate of a member nominated to the Panel by
that body.
(3) If a member (including the chairperson) is absent
from a meeting of the Panel, the member’s alternate (if any) is entitled to
attend the meeting and, when so attending, is taken to be a member of the
Panel.
(3A) If a person appointed by a body mentioned in paragraph
42T (1) (b), (c) or (d) ceases to hold office as a member:
(a) the person who was the person’s alternate
under subregulation (3) immediately before the person ceased to hold office; or
(b) in the absence of an alternate under
paragraph (a), a person who was, under subregulation (2), available to be the
alternate of the person who ceased to hold office;
is entitled to attend meetings of the Council while the office is
vacant and, when so attending, is taken to be a member of the Council.
(3B) The person described in paragraph 3A (a) or (b) is
taken to be the alternate of a person nominated to the vacant office until a
new alternate is appointed.
(4) If the chairperson
ceases to hold office:
(a) the person who was the person’s alternate
immediately before the person ceased to hold office is entitled to attend
meetings of the Panel while the office is vacant and, when so attending, is
taken to be a member of the Panel; and
(b) the person is taken to be the alternate of a
person nominated to the vacant office until a new alternate is appointed.
(5) A person appointed by a body as an alternate may
resign the appointment by notice in writing to the body.
42X Observers
to Panel
(1) The Therapeutic Goods Administration must nominate a
person to attend meetings of the Panel as an observer.
(2) Food Standards Australia New Zealand may nominate a
person to attend meetings of the Panel as an observer.
(3) A person nominated as an observer is entitled, until
the nomination is revoked:
(a) to be given the agenda and minutes of Panel
meetings, as if the person were a member of the Panel; and
(b) by notice in writing to the chairperson
suggest agenda items to be considered by the Panel; and
(c) to attend meetings of the Panel and vote on
any question in accordance with regulation 42Z.
42Y Quorum
(1) Subject to subregulations (2) and (3), at a meeting
of the Panel, a quorum exists if the chairperson and 4 other persons, being
members of the Panel or observers to the Panel, are present.
Note See regulation 42T in relation to
the nomination of members of the Panel and regulation 42X in relation to the
nomination of observers to the Panel.
(2) If a complaint about a medical device or other
therapeutic goods is to be considered at a meeting of the Panel, the quorum
must include the member nominated under subregulation 42T (1A) for that
meeting.
(3) A quorum for a meeting convened to consider a
complaint does not include a member of the Panel if the complaint was made by:
(a) the member; or
(b) the body that nominated the member.
42Z Meetings
(1) Meetings of the Panel are to be held at the
times and places that the chairperson directs.
(2) The chairperson is to preside at meetings of the
Panel at which he or she is present.
(3) If the chairperson or chairperson’s alternate is
absent from a meeting, a member nominated by the chairperson or, if no member
is nominated, a member chosen by the members of the Panel present at the
meeting, is to preside.
(4) A question arising at a meeting of the Panel is to
be decided by a majority of the votes of the members and observers present and
voting, with the person presiding at the meeting having a casting vote.
(5) An observer is entitled to vote at a meeting on any
question affecting the interests of the body nominating the observer.
42ZA Effect
of vacancy
The exercise of a power or performance of a
function of the Panel is not affected by any vacancy in the membership of the
Panel.
42ZB Disclosure
of interest
(1) A member of the Panel (including a person
taken to be a member under regulation 42W) who has a direct or indirect
pecuniary interest in a matter being considered or about to be considered at a
meeting of the Panel must, as soon as possible after the relevant facts have
come to the member’s knowledge, disclose the nature of the interest at a
meeting of the Panel.
(2) The disclosure is to be recorded in the minutes of
the meeting and the member must not, unless the Panel otherwise determines:
(a) be present during any deliberation of the
Panel with respect to the matter; or
(b) take part in any decision of the Panel with
respect to that matter.
(3) For the purpose of the making of a determination in
relation to the member who has made the disclosure, any member who has a direct
or indirect pecuniary interest in the matter to which the disclosure relates
must not:
(a) be present during any deliberation of the
Panel for the purpose of making the determination; or
(b) take part in the making of the determination
by the Panel.
(4) Subregulations (1), (2) and (3) apply to an observer
to the Panel who is intending to take part in any decision of the Panel on a
matter as they apply to a member.
42ZC Reports
to Council
(1) The Panel must give to the Therapeutic Goods
Advertising Code Council periodic written reports on the operation of the Panel
during a reporting period.
(2) Each reporting period must be for a consecutive
period of not more than 12 months.
(3) The Panel must consult with the Therapeutic Goods
Advertising Code Council to determine the first reporting period.
(4) A report must be given as soon as practicable after
the end of the reporting period to which it relates.
Subdivision 2 Procedure —
Complaints about advertisements and generic information
42ZCAA Definitions
for Subdivision 2
In this Subdivision:
complaint means a complaint about an
advertisement or generic information made to the Complaints Resolution
Panel in accordance with regulation 42ZCAB.
person apparently responsible, in relation to
a complaint about an advertisement or generic information, means
the person who, based on the complaint and the assessment of the Complaints
Resolution Panel, appears to be responsible for requesting the publication or
insertion of the advertisement or generic information in specified media.
42ZCAB Complaints about advertisements or generic
information
(1) A person may complain in writing to the Complaints
Resolution Panel that:
(a) an advertisement about designated
therapeutic goods that is published or inserted in specified media or broadcast
media contravenes:
(i) subsection 22 (5) or section
42C, 42DL, 42DM or 42DP of the Act; or
(ii) these Regulations; or
(iii) the Therapeutic Goods Advertising
Code; or
(b) an advertisement about medical devices or
other therapeutic goods that is published or inserted in specified media or
broadcast media contravenes:
(i) subsection 22 (5) or
41FN (5) of the Act; or
(ii) these Regulations; or
(iii) the Therapeutic Goods Advertising
Code.
(2) A person may complain in writing to the Complaints
Resolution Panel that generic information, to which Division 4 of Part 5‑1
of the Act applies, that is published or inserted in specified media or
broadcast media contravenes that Division.
42ZCAC Procedure
on receipt of a complaint
(1) If the Panel receives a complaint, the
Panel:
(a) must give, to the complainant (if known) and
the person apparently responsible, written notice that the complaint has been
received; and
(b) may make initial inquiries so that the
details and background of the complaint are available to the Panel when it
considers the complaint
(2) The notice must:
(a) give details of the complaint; and
(b) invite the complainant (if known) and the
person apparently responsible to send written submissions to the Panel,
together with any supporting documents.
42ZCAD Dealing with complaint
(1) The Panel must consider a complaint and
decide whether the complaint is justified.
(2) In considering the complaint, the Panel must have
regard to:
(a) any written submissions and documents given
to the Panel; and
(b) the results of its inquiries (if any); and
(c) information obtained about the complaint.
(3) A member of the Panel must not participate in the
Panel’s consideration of a complaint if the complaint was made by:
(a) the member; or
(b) the body that nominated the member.
42ZCAE Powers of Panel
(1) The Panel may inform itself on any matter, and
consult such persons, as it thinks fit.
(2) The Panel may require the person apparently
responsible or the sponsor to produce evidence in support of a
claim made in an advertisement or in generic information that is the subject of
a complaint.
42ZCAF Withdrawal of complaint
(1) The complainant may withdraw a complaint at
any time.
(2) The Panel may treat a complaint as withdrawn if,
before dealing with the complaint under regulation 42ZCAD, the Panel is
satisfied that:
(a) the complaint is trivial, vexatious,
misconceived or lacking in substance; or
(b) the subject matter of the complaint has been
dealt with by the Panel or by another authority; or
(c) the subject matter of the complaint can more
effectively or conveniently be dealt with by another authority; or
(d) both:
(i) the complainant does not intend to
proceed with the complaint; and
(ii) on the basis of the complaint,
there does not appear to have been any contravention of the Act, these
Regulations or the Therapeutic Goods Advertising Code.
(3) If the complaint is withdrawn under
subregulation (1), the Panel must inform the person apparently responsible
of the fact.
(4) If the Panel treats a complaint as withdrawn under
subregulation (2), the Panel must give written notice to the complainant
(if known) and the person apparently responsible of the Panel’s decision and
the reasons for the decision.
42ZCAG Dealing
with subject matter despite withdrawal of complaint
(1) The Panel may deal with the subject matter of a
complaint despite the withdrawal of the complaint if it appears to the Panel
that there may have been a contravention of the Act, these Regulations or the
Therapeutic Goods Advertising Code.
(2) If the Panel decides to deal with the subject matter
of a complaint under subregulation (1), the Panel must give written notice of
its decision and the reasons for the decision to the person apparently
responsible.
42ZCAGA Panel
may refer complaint to another authority
(1) If the Panel is satisfied that:
(a) the subject matter of a complaint, or the
advertisement or generic information to which a complaint relates, involves a
matter that could more effectively or conveniently be dealt with by another authority;
and
(b) a complaint relating to the matter could have
been made by the complainant to the authority;
the Panel may, in writing, refer the matter, and any material
before the Panel relating to the matter, to the authority.
(2) If the Panel refers a matter to another authority,
the Panel must give written notice of its decision to the complainant
(if known) and the person apparently responsible.
(3) The referral of a matter under subregulation (1)
does not prevent the Panel from dealing with other matters to which the
complaint relates in accordance with this Subdivision.
(4) This regulation applies despite the withdrawal of
the complaint.
42ZCAH Dealing
with matters not specified in complaint
(1) The Panel may deal with a matter that is not mentioned
in a complaint if it is satisfied that the advertisement or generic information
to which the complaint relates may contravene the Act, these Regulations or the
Therapeutic Goods Advertising Code in some other way
(2) If the Panel decides to deal with a matter under
subregulation (1), the Panel must give written notice of its decision to the
person apparently responsible.
(3) The notice must:
(a) give details of the matter not mentioned in
the complaint and the possible contravention of the Act, these Regulations or
the Therapeutic Goods Advertising Code that are to be dealt with by the Panel;
and
(b) invite the person apparently responsible to
send written submissions to the Panel, together with any supporting documents.
(4) This regulation applies despite the withdrawal of
the complaint.
42ZCAI Action
that Panel may take
(1) If, in relation to a
complaint about an advertisement, the Panel is satisfied that there has been a
contravention of the Act, these Regulations or the Therapeutic Goods Advertising
Code, the Panel may request in writing the person apparently responsible to do
one or more of the following:
(a) withdraw the advertisement;
(b) publish a retraction;
(c) publish a correction;
(d) withdraw a particular claim or representation
made by the advertisement, and give the Panel a written undertaking not to use
that claim or representation in any other advertisement unless the person
apparently responsible satisfies the Panel that the use of the claim or
representation would not result in a contravention of the Act, these
Regulations or the Therapeutic Goods Advertising Code.
(2) If, in relation to a complaint about generic
information, the Panel is satisfied that there has been a contravention of the
Act, these Regulations or the Therapeutic Goods Advertising Code, the Panel may
request in writing the person apparently responsible to do one or more of the
following:
(a) withdraw the generic information;
(b) publish a retraction;
(c) publish a correction;
(d) withdraw a particular claim or representation
made by the generic information, and give the Panel a written undertaking not
to use that claim or representation in any other generic information unless the
person apparently responsible satisfies the Panel that the use of the claim or
representation would not result in a contravention of the Act, these
Regulations or the Therapeutic Goods Advertising Code.
(3) If the person apparently responsible:
(a) does not comply with a request under
subregulation (1) or (2) within 14 days after the request is made; or
(b) breaches an undertaking given under
paragraph (1) (d) or (2) (d);
the Panel may make a recommendation to the
Secretary about the advertisement or generic information.
(4) Without limiting subregulation (3), the Panel may
recommend that the Secretary do one or more of the following:
(a) if the advertisement is an approved
advertisement — withdraw the approval of the advertisement;
(b) cancel the registration or listing of the
goods under paragraph 30 (2) (e) of the Act;
(ba) order the withdrawal of the advertisement or
generic information;
(c) order the publication of a retraction;
(d) order the publication of a correction;
(e) order the recovery of any advertisement or
generic information that is still in circulation;
(f) order the destruction of the advertisement
or generic information;
(g) suspend a kind of medical device from the
Register under Part 4‑6 of the Act;
(h) cancel the entry of a kind of medical device
from the Register under Part 4‑6 of the Act;
(i) order that a particular claim or
representation made by the advertisement or generic information be withdrawn,
and not be used in any other advertisement or generic information unless the
person apparently responsible satisfies the Panel that the use of the claim or
representation would not result in a contravention of the Act, these
Regulations or the Therapeutic Goods Advertising Code.
(5) The Panel must give written notice of a decision
under subregulation (1) or (2), or a recommendation under subregulation (3), to
the complainant (if known) and the person apparently responsible, setting out
its reasons.
42ZCAJ Panel
not to deal with complaint if court proceedings begun
(1) The Panel cannot deal with a complaint if a
proceeding has begun in a court about the subject matter of the complaint and
the proceeding has not been finally disposed of.
(2) If, after a complaint has been made to the Panel, a
proceeding begins in a court about the subject matter of the complaint, the
Panel cannot deal with the complaint until the proceeding is finally disposed
of.
42ZCAK Procedure
generally
So far as these Regulations do not provide for the
procedure of the Panel, the Panel may determine its own procedure.
42ZCAL Register
of complaints
(1) The Panel may publish, including on the Internet, a
register of complaints and related information.
(2) The register may include copies of, and information
about, the following:
(a) complaints received by the Panel;
(b) decisions made by the Panel under regulation
42ZCAD in relation to complaints;
(c) action taken by the Panel under regulation
42ZCAI in relation to complaints;
(d) statements of reasons given for decisions or
action mentioned in paragraph (b) or (c);
(e) any other information that the Panel
considers appropriate.
Division 3A National Drugs and Poisons Schedule Committee
Subdivision 1 Preliminary
42ZCA Definitions
for Division 3A
In this Division:
Committee means the National Drugs and
Poisons Schedule Committee.
Note The Committee is established by s 52B
of the Act.
jurisdictional member has the meaning given
by regulation 42ZCE.
Subdivision 2 Functions of
Committee
42ZCB Committee
may establish subcommittees
(1) To assist in the performance of its functions, the
Committee may, with the approval of the National Manager of the Therapeutic
Goods Administration, appoint subcommittees, comprising at least 1 member of
the Committee and other persons with appropriate expertise and experience.
(2) The function of a subcommittee is to inquire into,
and report to the Committee on, any matter, within the functions of the
Committee, that is referred to it by the Committee.
(3) A subcommittee may
make recommendations to the Committee.
Note Section 52C of the Act sets out
the functions of the Committee.
Subdivision 3 Constitution of
Committee
42ZCC Membership
of Committee
The Committee is constituted in accordance with
this Subdivision.
42ZCD Committee
members
(1) The Committee comprises each jurisdictional member
and other persons appointed by the Minister under this regulation.
(2) The Minister may appoint as a member an expert or a
representative.
(3) Each of the following persons is an expert:
(a) a medical practitioner expert in clinical
pharmacology;
(b) an expert in veterinary medicine or
pathology;
(c) an expert in toxicology;
(d) an expert in occupational health.
(4) Each of the following persons is a representative:
(a) a person nominated by the Therapeutic Goods
Administration;
(b) a person nominated by the National
Registration Authority for Agricultural and Veterinary Chemicals;
(c) a person nominated by an agency of the New
Zealand government responsible for the regulation of medicines for human use;
(d) a person nominated by an agency of the New
Zealand government responsible for the regulation of agricultural, veterinary
and household chemicals;
(e) a person whom the Minister is satisfied
represents the pharmaceutical, chemical, agricultural and veterinary
industries;
(f) a person whom the Minister is satisfied
represents practising pharmacists;
(g) a person whom the Minister is satisfied
represents consumers.
(5) For each category mentioned in subregulation (4),
1 representative only may be appointed.
42ZCE Jurisdictional
members
The following persons are jurisdictional members of
the Committee:
(a) each representative nominated under
subsection 52B (3) of the Act;
(b) each of the persons appointed as a
representative under paragraph 42ZCD (4) (c) or (d).
Note Only one of the persons appointed as
a representative under para 42ZCD (4) (c) or (d) is counted as a
jurisdictional member for r 42ZCQ and 42ZCR.
42ZCF Appointment
to be in writing
An appointment of a Committee member must be in
writing.
42ZCG Appointment
of Chair
The Minister must appoint a Committee member who is
a Commonwealth officer to be the chair of the Committee.
Note Committee members who could be
Commonwealth officers are the persons mentioned in
para 42ZCD (4) (a) and (b) and the representative nominated by
the Commonwealth under subs 52B (3) of the Act.
42ZCH Term
of appointment
(1) Subject to regulation 42ZCK, a representative
nominated under subsection 52B (3) of the Act is a Committee member
for 3 years, or a shorter period stated in the person’s nomination.
(2) Subject to regulation 42ZCK, a Committee member
appointed under regulation 42ZCD is appointed for the term stated in the
member’s appointment.
(3) The term stated in an appointment must not be
greater than 3 years.
(4) However, a Committee member may be nominated or
appointed for further terms of up to 3 years each.
(5) The Chair of the Committee is appointed as Chair for
the term stated in the appointment.
(6) The Chair may be reappointed for further terms.
42ZCI Resignation
A Committee member may resign by signed notice of
resignation given to the Minister.
42ZCJ Disclosure
of interests
(1) A Committee member who is aware that he or
she has a direct or indirect pecuniary interest in a matter being considered,
or about to be considered, at a meeting of the Committee must, without delay, disclose
the nature of the interest at, or before, the meeting of the Committee.
(2) The disclosure must be recorded in the minutes of
the meeting and the member must not, unless the Committee otherwise determines:
(a) be present during any deliberation of the
Committee about the matter; or
(b) take part in any decision of the Committee
about that matter.
(3) When the Committee is making a determination under
subregulation (2) about a member who has made a disclosure, the member, and any
other member who has a direct or indirect pecuniary interest in the matter to
which the disclosure relates, must not:
(a) be present during any deliberation of the
Committee; or
(b) take part in making the determination.
42ZCK Termination of Committee membership
(1) The Minister may terminate the membership of a
Committee member (including a jurisdictional member) on the grounds of:
(a) physical or mental incapacity; or
(b) misbehaviour; or
(c) incompetence; or
(d) inefficiency; or
(e) failing to comply, either recklessly or
intentionally, with regulation 42ZCJ.
(2) The Minister must terminate the membership of a
member (including a jurisdictional member) if the member:
(a) is convicted of an offence punishable by
imprisonment for 1 year or longer; or
(b) is absent without leave of absence from 3
consecutive meetings of the Committee.
42ZCL Leave
of absence
(1) The Minister may grant leave of absence to the Chair
of the Committee.
(2) The Chair may grant leave of absence to another
Committee member.
(3) If the Chair grants leave of absence to another
Committee member, the Chair may allow another person to replace the absent
member for no more than 2 consecutive meetings.
(4) A replacement must have qualifications, experience
and, if appropriate, expertise similar to the absent member.
Subdivision 4 Committee
procedures
42ZCM Committee procedures
For subsection 52B (2) of the Act, this
Subdivision sets out the procedures that the Committee must follow in holding
meetings.
42ZCN Committee procedures generally
In performing its functions, the Committee:
(a) must
act according to these Regulations; and
(b) must act with as
little formality and as quickly as the requirements of these Regulations, and a
proper consideration of the issues before the Committee, allow;
and
(c) is not bound by rules of
evidence; and
(d) may obtain information about
an issue in any way it considers appropriate.
42ZCO Meetings
(1) The Chair of the Committee
may, by written notice to the Committee,
direct the Committee to hold meetings at the
times and places, and to deal with matters in the manner, stated in the notice.
(2) If the Chair of the
Committee considers it appropriate and efficient in the circumstances,
the Committee may be directed to meet by videoconference or teleconference or
to meet out of session.
(3) For this regulation:
out of session, in relation to a meeting,
means a meeting in which the members take part by correspondence, electronic
mail, telephone or in any other way that does not involve formal simultaneous
meeting and voting.
(4) Subject to these
Regulations, the procedure of a Committee’s
meeting is as decided by the Committee.
42ZCP Presiding member
(1) The Chair of the Committee
must:
(a) preside at a Committee meeting; or
(b) nominate, in writing, a member of the
Committee to preside at the meeting.
(2) If the Chair is
temporarily absent from a meeting, the members present must choose a
jurisdictional member to preside.
42ZCQ Quorum
(1) At a Committee meeting,
a quorum exists if 11 members (including 5 jurisdictional members) are present.
(2) For this regulation, only one of the persons
appointed as a representative under paragraph 42ZCD (4) (c)
or (d) can be counted as a jurisdictional member.
42ZCR Voting
(1) A decision of the Committee
is made by a majority of the members present and voting for the decision
at a Committee meeting.
(2) However, a decision has no effect unless the
majority includes a majority of the jurisdictional members present and voting.
(3) If both of the persons appointed as a representative
under paragraph 42ZCD (4) (c) or (d) are present at a Committee
meeting, only one of them may vote on a decision as the jurisdictional member.
(4) If it is necessary to determine which of the persons
mentioned in subregulation (3) may vote as the jurisdictional member, that
person is:
(a) for an issue about the regulation of
medicines for human use — the person appointed under paragraph 42ZCD
(4) (c); or
(b) in any other case — the person appointed
under paragraph 42ZCD (4) (d).
(5) The member presiding at a Committee meeting has a
deliberative vote and also has a casting vote:
(a) in the event of an equality of votes of all
members present; and
(b) in the event of an equality of votes of
jurisdictional members present.
42ZCS Records
and reports
(1) The Committee must keep a record of its proceedings.
(2) The Committee must prepare any other report about
its activities that is requested by the Minister or the Secretary.
Note Regulation 42ZCX is about
records of scheduling decisions.
Subdivision 5 Scheduling
procedures
42ZCT Definitions
for Subdivision 5
In this Subdivision:
public submission means a submission
to the Committee by a person who is not a member of the Committee.
scheduling meeting means a Committee meeting
for the scheduling of a substance.
Note For current Poisons Standard,
scheduling and substance, see s 52A of the
Act.
42ZCU Public
notice of scheduling meetings
(1) Before a scheduling meeting, the Chair of the
Committee must publish a notice in the Gazette:
(a) mentioning the date of the proposed
scheduling meeting; and
(b) mentioning each substance to be considered
for scheduling at the meeting; and
(c) inviting public submissions to be made by a
date mentioned in the notice as the closing date for public submissions (the closing
date).
(2) The closing date must be at least 4 weeks after
publication of the Gazette notice.
(3) The date of the meeting must be at least a week
after the closing date.
42ZCV Consideration
of public submissions
(1) The Committee, in making a decision in relation to
the classification and scheduling of a substance, must consider all public
submissions made by the closing date that address a matter mentioned in
section 52E of the Act.
(2) The Committee need not consider a public submission
made after the closing date.
42ZCW Other
matters to be considered by Committee
(1) A submission prepared in relation to a substance by
a Committee member and submitted before or at the meeting about the scheduling
of the substance must be considered by the Committee at the meeting.
(2) The Committee must also take into account any
recommendation of a subcommittee about the substance.
42ZCX Record
of reasons for scheduling decisions
The Committee must make a record of the reasons for
a scheduling decision.
Note Regulation 42ZCS provides that
the Committee must keep a record of its proceedings.
42ZCY Public
notice of amendment
(1) A notice under subsection 52D (4) of the
Act must include:
(a) an indication of the amendment; and
(b) instruction on how the record of the reasons
for the amendment may be accessed; and
(c) an invitation to persons who made a public
submission in relation to the substance the subject of the amendment to make a
further submission.
(2) An amendment must not be expressed to come into
force earlier than 4 weeks after publication of the notice.
(3) Nothing in subregulation (1) requires the
Committee to disclose in the notice, or to provide access to, information that
it properly regards as requiring confidentiality for commercial reasons.
42ZCZ Further
public submissions
(1) A submission in response to an invitation mentioned
in paragraph 42ZCY (1) (c) must be made within 2 weeks after
publication of the notice making the invitation.
(2) The submission must:
(a) address a matter mentioned in
section 52E of the Act; and
(b) be relevant to the reasons recorded for
making the amendment.
(3) If a submission is made to the Committee under this
regulation, the Committee must consider the submission and then:
(a) confirm the amendment; or
(b) vary the amendment; or
(c) set aside the amendment, replace it with a
new scheduling decision and publish notice of the decision under
section 52D of the Act.
42ZCZA Public
consultation by subcommittee
(1) The Committee may assign its public consultation
responsibilities and functions under this Subdivision to a subcommittee.
(2) The subcommittee must give the Committee a written
report setting out the manner of its compliance with those responsibilities and
functions.
Note Regulation 42ZCB deals with
subcommittees.
42ZCZB Urgent
scheduling
(1) This regulation applies if the Chair of the
Committee considers that, in the interests of public health and safety, urgent
scheduling of a substance is necessary.
(2) If it is not practicable to follow the procedures
for public consultation prescribed by this Subdivision before scheduling, the
Committee may make a scheduling decision without following the procedures.
(3) A scheduling decision made without following the
procedures must be reviewed by the Committee as soon as practicable.
(4) The procedures for public consultation prescribed by
this Subdivision apply to the review as if the review were a scheduling
meeting.
Division 4 Complementary Medicines Evaluation Committee
Subdivision 1 Interpretation
42ZD Definition
In this Division:
Committee means the Complementary Medicines
Evaluation Committee.
Note The Complementary Medicines
Evaluation Committee is established by section 52G of the Act.
Subdivision 2 Functions of
Committee
42ZE Committee’s
evaluating function
(1) The Committee may evaluate, and report to the
Minister or Secretary about any of the following:
(a) a complementary medicine;
(b) an ingredient in a complementary medicine;
(c) a kind of ingredient in a complementary
medicine;
(d) therapeutic goods referred to the Committee,
by the Minister or the Secretary, for this regulation.
(2) The matters to be
included in a report include a recommendation about the following, as
applicable:
(a) whether or not a complementary medicine
should remain in the Register;
(b) whether or not a complementary medicine
should be included in the Register;
(c) whether or not an ingredient or kind of
ingredient should be included in Schedule 14, or mentioned in Schedule 4 as the
therapeutically active ingredient in a preparation mentioned in item 3 of Part
1 of that Schedule.
42ZF Committee
may give advice to Minister or Secretary
(1) The Committee may, in relation to a thing mentioned
in subregulation 42ZE (1), give the Minister or Secretary scientific and
policy advice about the following matters, as applicable:
(a) the import or export of the complementary
medicine, ingredient, kind of ingredient or kind of therapeutic goods;
(b) registration or listing of the complementary
medicine, ingredient, kind of ingredient or kind of therapeutic goods;
(c) the manufacture, supply and use of the
complementary medicine, ingredient, kind of ingredient or kind of therapeutic
goods.
Note For the definition of supply,
see subsection 3 (1) of the Act.
(2) An advice given about a thing mentioned in
subregulation (1) may include, as applicable:
(a) the Committee’s opinion about its safety;
and
(b) an assessment of short‑term and long‑term
risks and claimed benefits of its use; and
(c) the Committee’s opinion about its quality;
and
(d) the Committee’s opinion about its efficacy;
and
(e) if the advice is about therapeutic
goods — the Committee’s opinion about the indications of therapeutic
goods; and
(f) if the advice is about therapeutic goods in
relation to which a claim has been made to which subsection 28 (6) of the
Act applies:
(i) the Committee’s opinion about the
claim; and
(ii) the Committee’s opinion about the
amount, standard or type of information or evidence used to support a claim.
Note For the definition of indications,
see subsection 3 (1) of the Act.
42ZG Committee
may establish sub‑committees
(1) The Committee may appoint sub‑committees,
consisting of members of the Committee and other persons.
(2) The function of a sub‑committee is to inquire
into, and report to the Committee on, any specified matter that is within the
functions of the Committee.
42ZH Minister
or Secretary may seek further advice
(1) If the Committee gives advice, under this Division,
to the Minister or the Secretary, the Minister or the Secretary may give a copy
of that advice to another Committee established under Division 1 of this Part.
(2) A Committee to which a copy of an advice is given
may make comments to the Minister or the Secretary about that advice.
42ZI Committee
may seek advice and assistance
The Committee may, in performing its functions
under this Division, seek advice from other persons.
Subdivision 3 Constitution of
Committee
42ZJ Establishment
and membership of Committee
The Complementary Medicines Evaluation Committee
established under subsection 52G (1) of the Act is constituted in
accordance with this Subdivision.
42ZK Appointment
of Committee members
(1) The Minister must appoint members of the Committee
in accordance with this regulation.
(2) An appointment of a member must be in writing.
(3) The Committee must include at least 8, but no more
than 12, members.
42ZL Expertise
and experience of members
(1) In appointing members, the Minister must take into
account candidates’ expertise and experience in the following fields:
(a) complementary medicine practice;
(b) consumer representation;
(c) general medical practice;
(d) herbal medicine;
(e) naturopathy;
(f) nutrition or nutritional medicine;
(g) pharmacognosy;
(h) pharmacology;
(i) governmental regulation;
(j) toxicology.
(2) At least 4 members of the Committee must have
professional clinical experience in a field mentioned in
subregulation (1).
42ZM Appointment
of Chair
The Minister must, in writing, appoint a member of
the Committee to be its Chair.
42ZN Minister
may nominate expert advisers
(1) The Minister may nominate a person to give expert
advice to the Committee to assist it in the performance of its functions.
(2) If the Minister nominates a person for this
regulation, the Committee may ask that person for advice about performing a
function of the Committee.
(3) No more than 8 persons may be nominated under this
regulation.
(4) Regulations 42ZO, 42ZP, 42ZQ and 42ZR apply to a
person nominated under this regulation as if he or she were a member of the
Committee.
Example
In nominating a person for
this regulation, the Minister may consider the person’s expertise and
experience in any of the following areas:
(a) traditional
Chinese medicine;
(b) homoeopathy;
(c) Ayurvedic
medicine;
(d) aromatherapy;
(e) regulatory
affairs, in particular, scheduling of medicines;
(f) formulating,
designing or manufacturing complementary medicines;
(g) consumer
representation.
42ZO Term
of appointment
(1) A Committee member is appointed for the term stated
in the member’s appointment.
(2) The term stated in the appointment must not be
greater than 3 years.
(3) However, a Committee member may be reappointed for
further terms of up to 3 years each.
(4) The Chair of the Committee is appointed as Chair for
the term stated in the Chair’s appointment.
(5) The Chair may be reappointed for further terms.
42ZP Resignation
A Committee member may resign by signed notice of
resignation given to the Minister.
42ZQ Disclosure
of interests
(1) A Committee member who is aware that he or
she has a direct or indirect pecuniary interest in a matter being considered,
or about to be considered, at a meeting of the Committee must, without delay,
disclose the nature of the interest at, or before, the meeting of the
Committee.
(2) The disclosure must be recorded in the minutes of
the meeting and the member must not, unless the Committee otherwise determines:
(a) be present during any deliberation of the
Committee about the matter; or
(b) take part in any decision of the Committee
about that matter.
(3) When the Committee is making a determination under
subregulation (2) about a member who has made a disclosure, the member, and any
other member who has a direct or indirect pecuniary interest in the matter to
which the disclosure relates, must not:
(a) be present during any deliberation of the
Committee; or
(b) take part in making the determination.
(4) A member of a sub‑committee under regulation
42ZG, who is aware that he or she has a direct or indirect pecuniary interest
in a matter being considered, or about to be considered, at a meeting of the
sub‑committee must, without delay, disclose the nature of the interest
at, or before, the meeting of the sub‑committee.
42ZR Termination of appointment
(1) The Minister may terminate a Committee member’s
appointment on the grounds of:
(a) physical or mental incapacity; or
(b) misbehaviour; or
(c) incompetence; or
(d) inefficiency; or
(e) failing to comply, either recklessly or
intentionally, with regulation 42ZQ.
(2) The Minister must terminate the member’s appointment
if the member:
(a) is convicted of an offence punishable by
imprisonment for 1 year or longer; or
(b) is absent without leave of absence from
3 consecutive meetings of the Committee.
42ZS Leave of absence
(1) The Minister may grant leave of absence to the Chair
of the Committee.
(2) The Chair may grant leave of absence to another
Committee member.
Subdivision 4 Committee
procedures
42ZT Committee procedures
For subsection 52G (3) of the Act, this
Subdivision sets out the procedures that the Committee must follow in holding
meetings.
42ZU Committee procedures generally
(1) In performing its functions, the Committee:
(a) must
act according to these Regulations; and
(b) must act with as
little formality and as quickly as the requirements of these Regulations, and a
proper consideration of the issues before the Committee, allow;
and
(c) is not bound by rules of
evidence; and
(d) may obtain information about
an issue in any way it considers appropriate; and
(e) may receive information or
submissions orally or in writing.
(2) In addition, the Committee must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions.
42ZV Meetings
(1) The Chair of the Committee
may, by written notice to the Committee,
direct the Committee to hold meetings at the
times and places, and to deal with matters in the manner, stated in the notice.
(2) Subject to these
Regulations, the procedure of a Committee’s
meeting is as decided by the Committee.
42ZW Presiding member
(1) The Chair of the Committee
must:
(a) preside at a Committee meeting; or
(b) nominate a member of the Committee to preside
at the meeting.
(2) If the Chair is temporarily absent from a meeting,
the member chosen by the members present must preside.
42ZX Quorum
At a Committee meeting,
a quorum exists when at least half of the members are present.
42ZY Voting
(1) A decision made at a Committee meeting by a majority of the votes of the members
present and voting is a decision of the Committee.
(2) The member presiding at a Committee meeting has a
deliberative vote and, in the event of an equality of votes, also has a casting
vote.
42ZZ Records
and reports
(1) The Committee must keep a record of its proceedings.
(2) The Committee must prepare any other report about
its activities that is requested by the Minister or the Secretary.
Division 5 Medicines Evaluation Committee
Subdivision 1 Interpretation
42ZZA Definitions
In this Division:
Committee means the Medicines Evaluation
Committee established by subregulation 42ZZB (1).
consultant physician has the meaning given in
section 3 of the Health Insurance Act 1973.
medical practitioner has the meaning given in
section 3 of the Health Insurance Act 1973.
Subdivision 2 Establishment of
Committee
42ZZB Establishment
and constitution of Committee
(1) A committee called the Medicines Evaluation
Committee is established.
(2) The Committee has the functions mentioned in
Subdivision 3 of this Division.
(3) The Committee must be constituted in accordance with
Subdivision 4 of this Division.
(4) The Committee must hold meetings, and make
decisions, in accordance with Subdivision 5 of this Division.
Subdivision 3 Functions of
Committee
42ZZC Committee’s
evaluating function
(1) The Committee may evaluate, and report to the
Minister or Secretary about, any of the following:
(a) an OTC medicine;
(b) an ingredient in an OTC medicine;
(c) a kind of ingredient in an OTC medicine;
(d) therapeutic goods identified by the
Committee;
(e) therapeutic goods referred to the Committee,
by the Minister or the Secretary, for this regulation.
Example
Examples of OTC medicines that the Committee may evaluate,
and report about, include:
·
OTC medicines that are included in the Register
·
OTC medicines for which an application for inclusion in the
Register has been made.
(2) The matters to be included in a report for
subregulation (1) include, if appropriate, a recommendation about whether
or not a particular kind of therapeutic goods should be included in the part of
the Register for listed goods.
42ZZD Committee
may give advice to Minister or Secretary
(1) The Committee may, in relation to a thing mentioned
in subregulation 42ZZC (1), give to the Minister or Secretary scientific
and policy advice about the following matters, as applicable:
(a) the import or export of the OTC medicine,
ingredient, kind of ingredient or kind of therapeutic goods;
(b) registration or listing of the OTC medicine,
ingredient, kind of ingredient or kind of therapeutic goods;
(c) the manufacture, supply and use of the OTC
medicine, ingredient, kind of ingredient or kind of therapeutic goods.
Note For the definition of supply,
see subsection 3 (1) of the Act.
(2) An advice given about a thing mentioned in
subregulation (1) may include, as applicable:
(a) the Committee’s opinion about its safety;
and
(b) an assessment of short‑term and long‑term
risks and claimed benefits of its use; and
(c) the Committee’s opinion about its quality;
and
(d) the Committee’s opinion about its efficacy;
and
(e) if the advice is about therapeutic
goods — the Committee’s opinion about the indications of the therapeutic
goods; and
(f) if the advice is about therapeutic goods in
relation to which a claim has been made to which subsection 28 (6) of the
Act applies:
(i) the Committee’s opinion about the
claim; and
(ii) the Committee’s opinion about the
amount, standard or type of information or evidence used to support a claim.
Note For the definition of indications,
see subsection 3 (1) of the Act.
42ZZE Committee
may establish sub‑committees
(1) The Committee may appoint sub‑committees,
consisting of members of the Committee and other persons.
(2) The function of a sub‑committee is to inquire
into, and report to the Committee on, any matter that is within the functions
of the Committee.
42ZZF Minister or Secretary may seek further advice
(1) If the Committee gives advice, under this Division,
to the Minister or the Secretary, the Minister or the Secretary may give a copy
of that advice to another committee established under the Act.
(2) A Committee to which a copy of an advice is given
may make comments to the Minister or the Secretary about that advice.
Example
Examples of Committees to which the Minister or Secretary
may give a copy of advice include:
·
the Complementary Medicines Evaluation Committee
·
the National Drugs and Poisons Schedule Committee
·
a committee established under Division 1 of this Part.
42ZZG Committee may seek advice and assistance
The Committee may, in performing its functions
under this Division, seek advice from other persons.
Subdivision 4 Constitution of
Committee
42ZZH Establishment and membership of Committee
The Committee is constituted in accordance with
this Subdivision.
42ZZI Appointment of Committee members
(1) The Minister must appoint members of the Committee
in accordance with this regulation.
(2) An appointment of a member must be in writing.
(3) The Committee must include at least 8, but no more
than 12, members.
42ZZJ Expertise
and experience of members
In deciding whether to appoint a person to be a
member of the Committee, the Minister must take into account the person’s
expertise and experience in the following fields:
(a) general medical practice;
(b) specialist medical practice of a kind
relevant to the Committee’s functions;
(c) pharmaceutical chemistry;
(d) pharmacology;
(e) toxicology;
(f) microbiology;
(g) community pharmacy;
(h) manufacture of medicines;
(i) government regulation;
(j) consumer representation.
Example
For paragraph (b), the Minister would need to take
into account candidates’ expertise and experience in medical specialties,
including paediatric and geriatric medicine.
42ZZK Appointment
of Chair
The Minister must, in writing, appoint a member of
the Committee to be its Chair.
42ZZL Minister
may nominate expert advisers
(1) The Minister may nominate a person to give expert
advice to the Committee to assist it in the performance of its functions.
(2) If the Minister nominates a person under
subregulation (1), the Committee may ask that person for advice about
performing a function of the Committee.
(3) The Committee may have no more than 8 such advisers.
(4) Regulations 42ZZM, 42ZZN, 42ZZO and 42ZZP apply to a
person nominated under this regulation as if he or she were a member of the
Committee.
42ZZM Term
of appointment
(1) A Committee member is appointed for the term stated
in the appointment.
(2) The term stated in an appointment must not be
greater than 3 years.
(3) However, a Committee member may be reappointed for
further terms of up to 3 years each.
(4) The Chair of the Committee is appointed as Chair for
the term stated in the Chair’s appointment.
(5) The Chair may be reappointed for further terms while
he or she is a member of the Committee.
42ZZN Resignation
A Committee member may resign by signed notice of
resignation given to the Minister.
42ZZO Disclosure
of interests
(1) A Committee member who is aware that he or
she has a direct or indirect pecuniary interest in a matter being considered,
or about to be considered, at a meeting of the Committee must, without delay,
disclose the nature of the interest at, or before, the meeting of the
Committee.
(2) The disclosure must be recorded in the minutes of
the meeting and the member must not, unless the Committee otherwise determines:
(a) be present during any deliberation of the
Committee about the matter; or
(b) take part in any decision of the Committee about
that matter.
(3) When the Committee is making a determination under
subregulation (2) about a member who has made a disclosure, the member, and any
other member who has a direct or indirect pecuniary interest in the matter to
which the disclosure relates, must not:
(a) be present during any deliberation of the
Committee; or
(b) take part in making the determination.
(4) A member of a sub‑committee under
regulation 42ZZE, who is aware that he or she has a direct or indirect
pecuniary interest in a matter being considered, or about to be considered, at
a meeting of the sub‑committee must, without delay, disclose the nature
of the interest at, or before, the meeting of the sub‑committee.
42ZZP Termination of appointment
(1) The Minister may terminate a Committee member’s
appointment on the grounds of:
(a) physical or mental incapacity; or
(b) misbehaviour; or
(c) incompetence; or
(d) inefficiency; or
(e) failing to comply, either recklessly or
intentionally, with regulation 42ZZO.
(2) The Minister must terminate the member’s appointment
if the member:
(a) is convicted of an offence punishable by
imprisonment for 1 year or longer; or
(b) is absent without leave of absence from
3 consecutive meetings of the Committee.
42ZZQ Leave
of absence
(1) The Minister may grant leave of absence to the Chair
of the Committee.
(2) The Chair may grant leave of absence to another
Committee member.
Subdivision 5 Committee
procedures
42ZZR Committee procedures
This Subdivision sets out the procedures that the
Committee must follow in holding meetings.
42ZZS Committee procedures generally
(1) In performing its functions, the Committee:
(a) must
act according to these Regulations; and
(b) must act with as
little formality and as quickly as the requirements of these Regulations, and a
proper consideration of the issues before the Committee, allow;
and
(c) is not bound by rules of
evidence; and
(d) may obtain information about
an issue in any way that it considers appropriate; and
(e) may receive information or submissions
orally or in writing.
(2) In addition, the Committee must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions.
42ZZT Meetings
(1) The Chair of the Committee
may, by written notice to the Committee,
direct the Committee to hold meetings at the
times and places, and to deal with matters in the manner, stated in the notice.
(2) Subject to these
Regulations, the procedure of a Committee’s
meeting is as decided by the Committee.
42ZZU Presiding member
(1) The Chair of the Committee
must:
(a) preside at a Committee meeting; or
(b) nominate, in writing, a member of the
Committee to preside at the meeting.
(2) If the Chair is temporarily absent from a meeting,
the member chosen by the members present must preside.
42ZZV Quorum
At a Committee meeting,
a quorum exists when at least half of the members are present.
42ZZW Voting
(1) A decision made at a Committee meeting by a majority of the votes of the members
present and voting is a decision of the Committee.
(2) The member presiding at a Committee meeting has a
deliberative vote and, in the event of an equality of votes, also has a casting
vote.
42ZZX Records
and reports
(1) The Committee must keep a record of its proceedings.
(2) The Committee must prepare any other report about
its activities that is requested by the Minister or the Secretary.
Part 7 Fees, costs and charges
43 Fees
(1) Subject to the other provisions of this Part, the
fee specified in column 3 of an item in Part 2 of Schedule 9 is prescribed for
the matter that, in relation to that fee, is specified in column 2 of the item.
(2) If, but for this subregulation, more than one fee
referred to in item 9 of Schedule 9 would otherwise apply in relation to:
(a) an application to carry out steps in the
manufacture of therapeutic goods at particular premises; or
(b) the inspection of licensed manufacturing
premises for the purposes of section 40 of the Act;
the fee that is the greatest applicable fee is the only fee that
applies in respect of that application or inspection.
43A When is no application fee payable?
(1) A fee is not payable in accordance with item 2 or 3
of Schedule 9 for an application for the registration or listing of a
therapeutic device if:
(a) the device was included in the Register
under regulation 10B immediately before the application is made; and
(b) the application is made because the effect of
an amendment of these Regulations is that:
(i) the device ceases to be required
to be listed and becomes required to be registered; or
(ii) the device ceases to be required
to be registered and becomes required to be listed.
(2) The applicable fee under item 2 or 3 of Schedule 9
for an application to transfer an entry of a kind of medical device from the
part of the Register for medical devices to the part of the Register for
registered goods, or the part of the Register for listed goods, is not payable
if the device ceases to be a medical device because of a declaration in force
under subsection 41BD (3) of the Act.
43AA Fee for
evaluation — reduction in certain circumstances
(1) The fee payable under Schedule 9 for an application
to which regulation 16D applies is reduced by 25% if the Secretary does not
notify the applicant of the decision on the application within the period
specified in subregulation 16D (3) that applies to the application.
(2) In the case of an application mentioned in
subregulation (1):
(a) the amount payable on lodgment of the
application is the amount of the fee reduced by 25%; and
(b) if the reduction mentioned in that
subregulation does not apply, the remainder of the fee is payable on the
notification of the decision on the application.
43AB Circumstances
in which inspection fee covered by annual charge
(1) A fee is not payable in accordance with item 9AB of
Schedule 9 for an inspection covered by the annual charge for a licence to
manufacture the therapeutic goods mentioned in that item.
(2) An inspection is covered by the annual charge for a
licence to manufacture the therapeutic goods if no more than 2 prior
inspections have been carried out at the metropolitan site, identified in the
licence, within the period of 3 years immediately preceding the relevant
inspection.
(3) In this regulation:
inspection means an inspection in relation to
a metropolitan site.
44 Testing
of samples — recovery of costs
If a person asks the Department to analyse a sample
of goods, the costs incurred by the Department in carrying out that analysis
are recoverable from that person as a debt due to the Commonwealth.
45 Waiver
or reduction of fees
(1) The Secretary may reduce by 70% the amount of the
evaluation fee specified in Schedule 9 that is payable in relation to the
supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of
Schedule 10) if the supply of those goods:
(a) is in the interest of public health; and
(b) would not be commercially viable for the
sponsor of the goods if the full amount of the fee were paid.
(2) The Secretary may waive, or reduce, an evaluation
fee prescribed in Schedule 9 in relation to an application (other than an
application relating to goods of a kind mentioned in Part 1 of
Schedule 10) if the applicant makes another application, or other applications,
in relation to therapeutic goods at the same time and the following
circumstances apply:
(a) the goods to which each application
relates:
(i) contain the same active
ingredient; or
(ii) are therapeutic devices;
(b) the information given in support of each
application has sufficient commonality, in respect of the goods, that a
simultaneous evaluation of the goods may conveniently be made.
(3) The Secretary may waive or reduce the application
and evaluation fees specified in Schedule 9 that are payable in relation to
therapeutic goods if:
(a) the goods were approved for importation and
supply by the Secretary under the Customs (Prohibited Imports) Regulations not
earlier than 2 years before the commencement of the Act and supply of those
goods has not commenced; or
(b) the goods were registered by the Health
Department of the State of Victoria under the Health Act 1958 of that
State not earlier than 2 years before the commencement of the Act and supply of
those goods has not commenced; or
(c) the goods were accepted for evaluation by
the Secretary or the Health Department of the State of Victoria before the
commencement of the Act.
(4) The Secretary may waive, or reduce, an evaluation
fee prescribed in Schedule 9 in relation to an application (other than an
application relating to goods of a kind mentioned in Part 1 of
Schedule 10):
(a) to register goods; or
(b) in relation to registered goods that are a
medicine — to vary the information entered in the Register;
if the Secretary has information relating to the goods that enables
the evaluation procedure to be abridged.
(4AA) The Secretary may waive, or reduce, an evaluation fee
prescribed in Schedule 9 in relation to a submission for goods of a kind
mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:
(a) supply of the goods in Australia is
necessary because of a public health emergency; and
(b) the waiver or reduction is necessary to
enable the goods to be supplied in Australia; and
(c) the Secretary has information relating to
the goods that allows the evaluation procedure to be abridged.
(4A) If the Secretary reduces the amount of the evaluation
fee payable on an application to register a therapeutic device included in Part
1 of Schedule 3, the amount of the reduced fee payable:
(a) for an application involving the evaluation
of:
(i) design; or
(ii) materials information; or
(iii) testing;
is $7 920;
(b) for an application involving the evaluation
of:
(i) manufacture; or
(ii) quality control; or
(iii) sterile manufacture; or
(iv) testing
information;
is $6 600;
(c) in the case of an application involving the
evaluation of 1 or both of the following:
(i) biocompatability;
(ii) pre‑clinical information;
is reduced to $6 600; and
(ca) in the case of an application involving the
evaluation of software — is reduced to $6 600;
(d) for an application involving the evaluation
of human clinical information — is $26 500;
(e) for an application involving the evaluation
of a confirmatory review of clinical information — is $6 600; and
(f) for an application involving confirmatory
evaluation of overseas reports or data lodged to support the application ¾ is $6 600.
(8) Subregulation (9) applies if:
(a) more than 1 application to register a
therapeutic device is made at the same time; and
(b) each application is made by the same sponsor;
and
(c) the device to which each application relates
is included in Part 1 of Schedule 3; and
(d) the information provided in support of each
application is sufficiently similar to enable evaluation of each device to be
undertaken simultaneously; and
(e) the sponsor pays the total amount of the fee
payable under item 6 in Schedule 9 for the principal application.
(9) The fee for each application to register a
therapeutic device (other than the principal application) to which
subregulation (8) applies:
(a) in the case of an application involving the
evaluation of any or all of the following:
(i) design;
(ii) materials information;
(iii) testing;
is reduced to $3 970; and
(b) in the case of an application involving the
evaluation of any or all of the following:
(i) manufacture;
(ii) quality control;
(iii) sterile manufacture;
(iv) testing information;
is reduced to $3 970; and
(c) in the case of an application involving the
evaluation of 1 or both of the following:
(i) biocompatability;
(ii) pre‑clinical information;
is reduced to $3 970; and
(ca) in the case of an application involving the
evaluation of software ¾ is
reduced to $3 970; and
(d) in the case of an application involving the
evaluation of human clinical information — is reduced to $3 970; and
(e) in the case of an application involving
confirmatory evaluation of overseas reports or data lodged to support the
application ¾ is reduced to $3 970.
(10) Subregulation (11) applies if:
(a) more than 1 application to vary written
information in the Register about a therapeutic device is made at the same
time; and
(b) each application is made by the same sponsor;
and
(c) the device to which each application relates
is included in Part 1 of Schedule 3; and
(d) the information provided in support of each
application is sufficiently similar to enable evaluation of each device to be
undertaken simultaneously; and
(e) the sponsor pays the total amount of the fee
payable under item 7 in Schedule 9 for the principal application.
(11) The fee for each application to vary written
information (other than the principal application) to which subregulation (10)
applies:
(a) in the case of an application involving
review of any or all of the following:
(i) design;
(ii) materials information;
(iii) testing;
is reduced to $1 460; and
(b) in the case of an application involving
review of any or all of the following:
(i) manufacture;
(ii) quality control;
(iii) sterile manufacture;
(iv) testing information;
is reduced to $1 460; and
(c) in the case of an application involving the
evaluation of 1 or both of the following:
(i) biocompatability;
(ii) pre‑clinical information;
is reduced to $1 460; and
(ca) in the case of an application involving the
evaluation of software — is reduced to $1 460;
and
(d) in the case of an application involving
review of human clinical information — is reduced to $1 460; and
(e) in the case of an application involving
confirmatory evaluation of overseas reports or data lodged to support the
application ¾ is reduced to $1 460.
(12) The Secretary must waive the following fees:
(a) a fee that would have been payable, but for
this subregulation, for applying to the Secretary under subregulation
16I (1) to have a medicine designated as an orphan drug;
(b) a fee that would have been payable, but for
this subregulation, for the Secretary considering the application under
regulation 16J;
(c) a fee that would have been payable, but for
this subregulation, as part of the registration of a designated orphan drug.
45AA Payment
of fees in instalments
(1) Subject to subregulation (7), the Secretary may
allow the amount of a fee payable under item 6 or 7 in Schedule 9 to be paid in
instalments, if:
(a) the applicant has applied in writing to pay
the amount in instalments; and
(b) the amount payable exceeds $10,000; and
(c) the Secretary is reasonably satisfied that
the applicant will experience financial hardship if that amount is paid before
the commencement of the evaluation to which the fee relates; and
(d) any information or material to which
subregulation (3) applies has been provided to the Secretary.
(2) An application under subregulation (1) must:
(a) state the reasons why payment of the full
amount of the fee before the evaluation commences will cause financial hardship
to the applicant; and
(b) have with it documents or other material in
support of the statement.
(3) If the Secretary reasonably requires information or
material in addition to the documents or material referred to in
paragraph 2 (b), the Secretary may require the applicant to provide
the information or material to the Secretary.
(4) If the Secretary approves an application under
subregulation (1):
(a) 50% of the fee is due for payment before the
commencement of the evaluation of the application; and
(b) 25% of the fee is due for payment at the end
of 1 month after the day on which the amount referred to in paragraph (a)
is due for payment; and
(c) the remaining 25% is due for payment:
(i) if the application for evaluation
is withdrawn — at the time of withdrawal; or
(ii) if the Secretary decides not to
register the therapeutic device — when the applicant is notified under
subsection 25 (3) of the Act; or
(iii) if the evaluation is
completed — before the therapeutic device is registered.
(5) If:
(a) the Secretary approves an application under
subregulation (1); and
(b) any amount of the fee payable by the
applicant is not paid when it becomes due for payment;
the balance of the fee becomes due for payment.
(6) If the Secretary receives an application under
subregulation (1), he or she must:
(a) give notice in writing to the applicant
within 30 days of receiving the application whether the application has been
approved; and
(b) if the application is approved — include
with the notice information about the amounts of the instalments and when the
instalments are due for payment.
(7) This regulation does not apply while another
evaluation fee, or an assessment fee payable under section 41LA of the Act
(or part of either of those kinds of fee), that is due for payment by the
applicant is unpaid.
45A Charges reduced if annual turnover is not
more than $71 000
(1) Subject to subregulation (2), if the wholesale
turnover of therapeutic goods of a person who is required to hold a licence
under Part 3‑3 of the Act is not more than $71 000 in a financial
year, the annual charge payable by the person for a licence that is in force at
any time during that financial year is half of the amount otherwise payable
under subregulation 3 (2) of the Therapeutic Goods (Charges)
Regulations 1990 in respect of that licence.
(2) Subregulation (1) does not apply in relation to the
annual charge payable in respect of a licence that is in force for the
manufacture of human blood and blood components.
Part 8 Miscellaneous
46A Delegation
under the Act
The appointment of National Manager, Therapeutic
Goods Administration is declared for the purposes of paragraph
57 (1) (c) of the Act to be an appointment the holder of which may be
a delegate of the Minister or the Secretary under section 57 of the Act.
46 Release
of information
(1) In this regulation, therapeutic goods
information has the same meaning as in section 61 of the Act.
(2) For the purposes of subsection 61 (6) of the
Act, the Secretary may release to a person, on application by the person,
therapeutic goods information in respect of an entry in the Register, being
therapeutic goods information of the following kinds:
(a) whether the goods are included in the
Register and, if so:
(i) the registration number, listing
number or device number of the goods; and
(ii) the date when the goods were
registered, listed or included in the Register; and
(iii) the class in which the goods are
included in the Register;
(b) the name of the goods and the name and
address of the sponsor of the goods;
(c) if any ingredient in, or component of, the
goods is derived from an animal, the type of the animal;
(d) if the goods are supplied in a sterile state,
the type of sterilisation used;
(e) if the goods are medicines, medical devices
that contain medicines, or medical devices that incorporate, or are intended to
incorporate, as an integral part, a medicine that is intended to act on a
patient in a way that is ancillary to the device:
(i) the quantity of goods to be in the
primary pack; and
(ii) the entry relating to the goods in
the Poisons Standard; and
(iii) the indications for the goods;
and
(iv) the dosage form of the goods and
their physical appearance; and
(v) the names and quantities of
therapeutically active substances in the goods; and
(vi) the presence or absence of any
specific excipient in the goods; and
(vii) the routes of administration of
the goods; and
(viii) the type of container in which the
goods are to be packed; and
(f) if the goods are a kind of medical device:
(i) the intended purpose of the
device; and
(ii) the device nomenclature system
code specified for the device under subsection 41BE (3) of the Act; and
(iii) the medical device classification
applying to the device;
(g) whether the goods are a designated orphan
drug.
(3) For the purposes of subsection 61 (6) of the
Act, the Secretary may release therapeutic goods information of a kind that
relates to the evaluation of therapeutic goods by the Australian Drug
Evaluation Committee by publishing the information in the Gazette.
(4) For the purposes of subsection 61 (6) of the
Act, the Secretary may release therapeutic goods information of a kind that a
court, tribunal, authority, or other body or person may require to be given or
produced under a law of the Commonwealth, or of a State or Territory.
47 Delegation —
powers and functions under these Regulations
(1) The Secretary may delegate a power or function of
the Secretary under these Regulations to:
(a) an officer of the Department; or
(b) the National Manager, Therapeutic Goods
Administration.
(2) The delegation must be by instrument signed by the
Secretary.
(3) Nothing in subregulation (1) affects the
Secretary’s power to delegate a power or function of the Secretary under
regulation 5Q or subregulation 9 (3).
47A Delegation —
powers under paragraph 19 (1) (a) of the Act
(1) In this regulation, delegation means a
delegation, under subsection 57 (3) of the Act, of powers of the Secretary
under paragraph 19 (1) (a) of the Act, that relates to specified
therapeutic goods.
(2) A delegation may only be to a person who:
(a) is a medical practitioner registered in a
State or Territory and employed by an institution that has an ethics committee;
and
(b) subject to subregulation (3), is proposed by
the medical superintendent or, if there is no medical superintendent, the
person occupying a position comparable to that of medical superintendent, of
the institution, as a person to be a delegate under subsection 57 (3) of
the Act.
(3) If:
(a) a person proposes another person under
paragraph (2) (b) as a person to be a delegate; and
(b) that other person becomes a delegate;
the first‑mentioned person must supervise each approval that
the delegate grants under the delegation.
(4) A delegation must describe the person or class of
persons to be treated with the therapeutic goods to which the delegation
relates.
(5) A delegation may be made for the purpose of allowing
the delegate to grant an approval in relation to:
(a) a particular item of therapeutic goods; or
(b) a particular
class of therapeutic goods;
for treating a specific illness or condition.
(6) A delegate may grant an approval under a delegation
only if:
(a) a medical practitioner other than the
delegate has stated in writing that the person to be treated with the item of
therapeutic goods to which the approval relates has an illness or condition
that requires treatment with the item; and
(b) an ethics committee has agreed to the
granting of approval under paragraph 19 (1) (a) of the Act for the
use, in the circumstances in which the delegate grants the approval, of the
item of therapeutic goods to which the delegation relates.
47B Provision
of information concerning medicines and medical devices
(1) The following persons
must provide a report to the Secretary every 6 months:
(a) a delegate under subsection 57 (3) of
the Act;
(b) a person authorised under subsection
19 (5) or 41HC (1) of the Act to supply a medicine or medical device;
(c) a sponsor of therapeutic goods.
(2) The report must be in a form approved by the
Secretary.
(3) A report by a person
mentioned in paragraph (1) (a) must:
(a) list each item of therapeutic goods
(including medical devices) approved by the person during the period to which
the report relates; and
(b) state the number of new approvals, and the
number of repeat approvals, of medicines and medical devices that the person
gave during that period.
(4) A report by a person mentioned in
paragraph (1) (b) must list each item of therapeutic goods (including
medical devices) supplied by the person during the period to which the report
relates.
(5) A report by a sponsor of therapeutic goods must:
(a) list each kind of therapeutic goods supplied
by the sponsor during the period to which the report relates; and
(b) state the
number of times therapeutic goods have been supplied to medical practitioners,
and the quantity supplied:
(i) to which section 18 or 41HA of the
Act applies; and
(ii) to which paragraph
19 (1) (a) or 41HB (1) (d) of the Act applies; and
(iii) to which paragraph
19 (1) (b) or 41HB (1) (e) of the Act applies; and
(iv) to which subsection 19 (5) or
41HC (1) of the Act applies.
48 Review
of decisions
(1) In this regulation:
decision has the same meaning as in the
Administrative Appeals Tribunal Act 1975.
initial decision means a decision of the
Secretary under any of the following provisions:
(a) subregulation
9 (1);
(c) subregulation 10A (7);
(ca) subregulation 10C (3), (4), (5) or (6);
(d) subregulation 10F (7);
(e) subregulation 16J (3);
(f) subregulation 22 (8);
(g) regulation 45;
(h) regulation 45AA.
reviewable decision means a decision of the
Minister under subregulation (3).
(1A) The Minister may, by signed instrument, delegate a
power or function of the Minister under this regulation to:
(a) an officer of the Department; or
(b) the National Manager, Therapeutic Goods
Administration.
(2) A person whose interests are affected by an initial
decision may request the Minister to reconsider the decision by notice in
writing given to the Minister within 90 days after the decision first comes to
the person’s notice.
(3) The Minister must reconsider the initial decision as
soon as practicable after receiving a request under subregulation (2), and may:
(a) confirm the initial decision; or
(b) revoke the initial decision, or revoke that
decision and make a decision in substitution for the initial decision.
(4) If a person who has made a request under subregulation
(2) does not receive notice of the decision of the Minister on reconsideration
within 60 days of the making of the request, the Minister is to be taken to
have confirmed the original decision.
(5) After reconsideration of an initial decision, the
Minister must give the applicant a notice in writing stating the result of the
reconsideration and that the applicant may, except where subsection 28 (4)
of the Administrative Appeals Tribunal Act 1975 applies, apply for
a statement setting out the reasons for the decision on reconsideration and
may, subject to that Act, make an application to the Administrative Appeals
Tribunal for review of that decision.
(6) If written notice of the making of an initial
decision is given to a person whose interests are affected by the decision, the
notice is to include a statement to the effect that a person whose interests
are affected by the decision may:
(a) seek a reconsideration of the decision under
this regulation; and
(b) subject to the Administrative Appeals
Tribunal Act 1975, if the person is dissatisfied with the decision upon
reconsideration, make an application to the Administrative Appeals Tribunal for
review of that decision.
(7) Any failure to comply with the requirements of
subregulation (5) or (6) in relation to a decision does not affect the validity
of the decision.
(8) An application may be made to the Administrative
Appeals Tribunal for review of a reviewable decision.