Therapeutic Goods (Victoria) Act 1994

Version No. 013

Therapeutic Goods (Victoria) Act 1994

No. 79 of 1994

Version incorporating amendments as at 25 January 2008

table of provisions

SectionPage

1

SectionPage

Part 1—Preliminary

1Purpose

2Commencement

3Definitions

4Definitions in Commonwealth Act

5Interpretation

6Act to bind Crown

7Authorised persons

8Secretary may approve or authorise the supply of certain therapeutic goods

9Power of Minister to exempt

10Kits

11Power to obtain information with respect to therapeutic
goods

Part 2—Standards

12Compliance with standards

13Consent may be subject to conditions etc.

Part 3—Australian Register of Therapeutic
Goods

Division 1—Preliminary

14Offences by sponsors

15Offence relating to supply of unregistered or unlisted goods

16Hawking of therapeutic goods

17Supply by vending machine

18General offences relating to this Part

19False statements in applications for registration

Division 2—Registration and listing

20Applications generally

21Applications for registration

22When evaluation fee due for payment

23Payment of evaluation fee by instalments

24Recovery of evaluation fee

25Reduction of evaluation fee where evaluation not
completed within prescribed period

26Deemed refusal of application

27Evaluation of therapeutic goods

28Listing of therapeutic goods

29Registration or listing number

30Conditions on registration or listing

31Duration of registration or listing

32Notification of adverse effects etc. of goods

33Notification of adverse effects etc. where application
withdrawn or lapses

34Cancellation of registration or listing

34AConsultation with Gene Technology Regulator

34BSecretary may seek advice about classes of GM products

34CSecretary to take advice into account

Division 3—General

35Secretary may require information

36Inspection and variation of entries in Register

37Publication of list of goods on Register

Part 4—Manufacturing of Therapeutic Goods

38Offences relating to manufacturing and licences

39Application for licence

40Grant of licence

41Term of licence

42Conditions of licences

43Revocation and suspension of licences

44Publication of list of manufacturers etc.

Part 5—Codes of Practice

45Codes of Practice

46Status of a Code of Practice

47Procedure for making or adopting Codes of Practice

48Commencement of Code of Practice

49Availability of Codes of Practice

50Tabling in Parliament

51Conviction of offence under Code of Practice

52Requirement to comply with Code of Practice

53Repealed

Part 6—Payment of Charges

54By whom charges payable

55Time for payment of charges

56Recovery of charges

Part 7—Miscellaneous

57Monitoring compliance with Act

58Entry and search of premises—evidence of offences

59General powers of authorised persons in relation to premises

60Monitoring warrants

61Offence related warrants

62Identity cards

63Offences

64Evidentiary certificate of Victorian Secretary

65Evidentiary certificates of the Secretary

66Conduct by directors, servants and agents

67Judicial notice

68Delegation

69Offences under this Act and the Commonwealth Act

70Review of decisions excluding decisions under Part 5

71Review by Victorian Civil and Administrative Tribunal

72Regulations

Part 8—Consequential Amendments and Transitional Provisions

73Amendments to the Health Act 1958

74Consequential amendment to the Food Act 1984

75Transitional arrangements for Part 4

76Repealed

77Transitional arrangements for goods required to be registered
or listed

═══════════════

ENDNOTES

1. General Information

2. Table of Amendments

3. Explanatory Details

1

Version No. 013

Therapeutic Goods (Victoria) Act 1994

No. 79 of 1994

Version incorporating amendments as at 25 January 2008

1

Therapeutic Goods (Victoria) Act 1994
No. 79 of 1994

The Parliament of Victoria enacts as follows:

Part 1—Preliminary

1Purpose

The purpose of this Act is to promote and facilitate the development of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods, and for that purpose, to make provision for the implementation in Victoria of controls relating to Victorian therapeutic goods complementary to the provision made by the Therapeutic Goods Act 1989 of the Commonwealth.

2Commencement

(1)Section 1 and this section come into operation on the day on which this Act receives the Royal Assent.

(2)Subject to subsections (3) and (4), the remaining provisions of this Act come into operation on a day or days to be proclaimed.

(3)If a provision referred to in subsection (2) (other than section 16, 17 or Part 5) does not come into operation within the period of 6 months beginning on, and including, the day on which this Act receives the Royal Assent, it comes into operation on the first day after the end of that period.

(4)If section 16, 17 or Part 5 of this Act do not come into operation within the period of 12 months beginning on, and including, the day on which this Act receives the Royal Assent, those provisions come into operation on the first day after the end of that period.

3Definitions

s. 3

In this Act—

advertisement, in relation to therapeutic goods, includes any statement, pictorial representation or design, however made, that is intended, whether directly or indirectly, to promote the use or supply of the goods;

annual licensing charge means an amount equal to the amount of the charge payable by the holder of the licence to which the charge relates under Part 5 of the Commonwealth Act;

annual listing charge means an amount equal to the amount of the charge payable by a person in relation to whom therapeutic goods are listed under Part 5 of the Commonwealth Act;

annual registration charge means an amount equal to the amount of the charge payable by a person in relation to whom therapeutic goods are registered under Part 5 of the Commonwealth Act;

S. 3 def. of authorised person amended by No. 46/1998
s. 7(Sch. 1).

authorised person means—

(a)in relation to any provision of this Act—

(i)a person authorised by the Victorian Secretary; or

(ii)an authorised person within the meaning of paragraph (a) of the definition of authorised personin the Commonwealth Act; or

(b)in relation to a provision of Part 7—

(i)a member of the police force of Victoria; or

(ii)a member of the Australian Federal Police;

British Pharmacopoeiahas the same meaning as in the Commonwealth Act;

British Pharmacopoeia (Veterinary)has the same meaning as in the Commonwealth Act;

S. 3 def. of Chief General Manager repealed by No. 46/1998
s. 7(Sch. 1).

*****

s. 3

S. 3 def. of Code of Practice insertedby No.74/2004 s.22(a).

Code of Practice means a Code of Practice made or adopted under Part 5;

Commonwealth Actmeans the Therapeutic Goods Act 1989 of the Commonwealth;

Commonwealth Departmentmeans the Department of Human Services and Health or such other Department of the Commonwealth as is the relevant Department for the purposes of the Commonwealth Act;

Commonwealth Ministermeans the Minister administering the Commonwealth Act;

Commonwealth regulationsmeans the regulations for the time being in force under the Commonwealth Act;

data processing devicemeans any article or material (for example, a disc) from which information is capable of being reproduced with or without the aid of any other article or device;

directions for use, in relation to therapeutic goods, includes information on—

(a)appropriate doses of the goods; and

(b)the method of administration or use of the goods; and

(c)the frequency and duration of treatment for each indication of the goods; and

(d)the use of the goods by persons of particular ages or by persons having particular medical conditions;

exempt goods—

(a)in relation to a provision of Part 3, means therapeutic goods that are exempt from the operation of Part 3 of the Commonwealth Act;

(b)in relation to a provision of Part 4, means therapeutic goods that are exempt from the operation of Part 4 of the Commonwealth Act;

s. 3

(c)in relation to any provision of this Act, means therapeutic goods that are exempt for the purposes of that provision because of an Order under section 9 of this Act where the goods are used, advertised or presented for supply in the way specified in the Order;

exempt person, in relation to therapeutic goods, means—

(a)a person exempt from the operation of Part 4 of the Commonwealth Act in relation to those goods; or

(b)in relation to a provision of this Act, a person exempt from that provision because of an Order under section 9;

S. 3 def. of Gene Technology Regulator inserted by No. 67/2001 s.196.

Gene Technology Regulator has the same meaning as Regulator in the Gene Technology Act 2001;

S. 3 def. of
GM product inserted by No. 67/2001 s.196.

GM product has the same meaning as in the Gene Technology Act 2001;

s. 3

indications, in relation to therapeutic goods, means the specific therapeutic uses of the goods;

label, in relation to therapeutic goods, means a display of printed information—

(a)on or attached to the goods;

(b)on or attached to a container or primary pack in which the goods are supplied; or

(c)supplied with such a container or pack;

S. 3 def. of licence amendedby No.74/2004 s.22(b).

licencemeans a licence under Part 4;

listable devicesmeans therapeutic devices that are required under this Act or the Commonwealth Act to be included in the part of the Register for listed goods;

listed goodsmeans therapeutic goods that are included in the part of the Register for goods known as listed goods;

listing number, in relation to listed goods, means any combination of numbers, symbols and letters assigned to the goods under section 29 of this Act or section 27 of the Commonwealth Act;

manufacture, in relation to therapeutic goods, means—

(a)to produce the goods; or

s. 3

(b)to engage in any part of the process of producing the goods or of bringing the goods to their final state, including engaging in the processing, assembling, packaging, labelling, storage, sterilising, testing or releasing for supply of the goods or of any component or ingredient of the goods as part of that process;

manufacturing premisesmeans premises (including premises that comprise 2 or more sites)—

(a)that are for use in the manufacture of a particular kind of therapeutic goods; and

(b)at which the same persons have control of the management of the production of the goods and the procedures for quality control;

manufacturing principlesmeans the principlesfor the time being having effect under section 36 of the Commonwealth Act;

premisesincludes—

(a)a structure, building, aircraft, vehicle or vessel; and

(b)a place (whether enclosed or built upon or not); and

(c)a part of a thing referred to in paragraph (a) or (b);

presentation, in relation to therapeutic goods, means the way in which the goods are presented for supply, and includes matters relating to the name of the goods, the labelling and packaging of the goods and any advertising or other informational material associated with the goods;

primary pack, in relation to therapeutic goods, means the complete pack in which the goods, or the goods and their container, are to be supplied to consumers;

s. 3

quality, in relation to therapeutic goods, includes the composition, strength, potency, stability, sterility, purity, bioburden, design, construction and performance characteristics of the goods;

Registermeans the Australian Register of Therapeutic Goods maintained under section17 of the Commonwealth Act;

registered goodsmeans therapeutic goods included in the part of the Register for goods known as registered goods;

registration number, in relation to registered goods, means any combination of numbers, symbols and letters assigned to the goods under section 29 of this Act or under section27 of the Commonwealth Act;

Secretarymeans the Secretary to the Commonwealth Department;

sponsor, in relation to therapeutic goods, means a person who, in Victoria, manufactures the goods, or arranges for another person to manufacture the goods, for supply (whether in Victoria or elsewhere) but does not include a person who—

(a)manufactures the goods; or

(b)arranges the manufacture of the goods—

on behalf of another person who, at the time of the manufacture or arrangements, is a resident of, or is carrying on business in, Victoria;

s. 3

standard, in relation to therapeutic goods, means a standard that—

(a)is specified in an order under section10 of the Commonwealth Act that is applicable to the goods in accordance with section 13 of that Act; or

(b)if no such order is so applicable to the goods but the goods are the subject of a monograph in—

(i)in the case of goods for use in humans, the British Pharmacopoeia; or

(ii)in the case of goods for use in animals, the British Pharmacopoeia (Veterinary)—

is constituted by the statements in that monograph;

supplyincludes—

(a)supply by way of sale, exchange, gift, lease, loan, hire or hire-purchase; and

(b)supply, whether free of charge or otherwise, by way of sample or advertisement; and

(c)supply, whether free of charge or otherwise, in the course of testing the safety or efficacy of therapeutic goods in persons or animals; and

(d)supply by way of administration to, or application in the treatment of, a person or animal;

s. 3

therapeutic devicemeans therapeutic goods consisting of an instrument, apparatus, appliance, material or other article (whether for use alone or in combination), together with any accessories or software required for its proper functioning, which does not achieve its principal intended action by pharmacological, chemical, immunological or metabolic means though it may be assisted in its function by such means, but the expression does not include therapeutic goods declared under the Commonwealth Act not to be therapeutic devices;

therapeutic goodsmeans goods—

(a)that are represented in any way to be, or that are, whether because of the way in which the goods are presented or for any other reason, likely to be taken to be—

(i)for therapeutic use; or

(ii)for use as an ingredient or component in the manufacture of therapeutic goods; or

(iii)for use as a container or part of a container for goods of the kind referred to in subparagraph (i) or(ii); or

(b)included in a class of goods the sole or principal use of which is, or ordinarily is, a therapeutic use or a use of a kind referred to in paragraph (a)(ii) or (iii)—

and includes goods declared to be therapeutic goods under an order in force under section 7 of the Commonwealth Act, but does not include—

(c)goods declared not to be therapeutic goods under an order in force under that section or under an Order under section 9 of this Act; or

s. 3

(d)goods in respect of which such an order is in force, being an order that declares the goods not to be therapeutic goods when used, advertised or presented for supply in the way specified in the order where the goods are used, advertised or presented for supply in that way; or

(e)foods;

therapeutic usemeans use in or in connection with—

(a)preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons or animals; or

(b)influencing, inhibiting or modifying a physiological process in persons or animals; or

(c)testing the susceptibility of persons or animals to a disease or ailment; or

(d)influencing, controlling or preventing conception in persons; or

(e)testing for pregnancy in persons; or

(f)the replacement or modification of parts of the anatomy in persons or animals;

S. 3 def. of Victorian Secretary inserted by No. 46/1998
s. 7(Sch. 1).

Victorian Secretary has the same meaning as Secretary in the Health Act 1958.

4Definitions in Commonwealth Act

s. 4

(1)Words and expressions used in the Commonwealth Act and in this Act have the same meanings in this Act as they have in the Commonwealth Act.

(2)Subsection (1) does not apply to the extent that the context or subject-matter otherwise indicates or requires.

5Interpretation

(1)For the purposes of this Act—

(a)therapeutic goods are to be taken to be for use in animals if—

(i)the goods bear a name or description that indicates, or is likely to give the impression, that the goods are intended for use in animals and are not intended for use in humans; or

(ii)the goods are otherwise represented, or otherwise purport, to be intended for use in animals and not intended for use in humans; and

(b)therapeutic goods are to be taken to be for use in humans if they are not solely for use in animals.

S. 5(2) amended by No. 46/1998
s. 7(Sch. 1) (as amended by No. 12/1999 s.3(Sch. 1 item 28)).

(2)The Victorian Secretary must, at least once in each year, cause to be published in the Government Gazette a list of the names of all persons who are, at the time of publication, persons authorised by the Victorian Secretary as authorised persons for the purposes of this Act.

(3)The provisions of this Act are in addition to, and not in substitution for, the provisions of any other Act that relate to therapeutic goods.

s. 5

(4)For the purposes of this Act, the presentation of therapeutic goods is unacceptable if it is capable of being misleading or confusing as to the content or proper use of the goods and, without limiting the previous words in this subsection, the presentation of therapeutic goods is unacceptable—

(a)if it states or suggests that the goods have ingredients, components or characteristics that they do not have; or

(b)if a name applied to the goods is the same as the name applied to other therapeutic goods that are supplied in Victoria where those other goods contain additional or different therapeutically active ingredients; or

(c)if the label of the goods does not declare the presence of a therapeutically active ingredient; or

(d)if a form of presentation of the goods may lead to unsafe use of the goods or suggests a purpose that is not in accordance with conditions applicable to the supply of the goods in Victoria; or

(e)in prescribed cases.

6Act to bind Crown

s. 6

This Act binds the Crown not only in right of Victoria but also, so far as the legislative power of the Parliament permits, the Crown in all its other capacities.

S. 7
amended by No. 46/1998
s. 7(Sch. 1).

7Authorised persons

The Victorian Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of this Act—

S. 7(a) amended by No. 46/1998
s. 7(Sch. 1).

(a)an employee in the public service;

(b)an officer of the Commonwealth Department or of another Department of the Commonwealth or of an authority of the Commonwealth, being a Department or authority that has functions relating to health matters or law enforcement matters.

8Secretary may approve or authorise the supply of certain therapeutic goods

(1)The Secretary may, by notice in writing, grant an approval to a person to supply specified therapeutic goods that are not either exempt goods or goods included in the Register—

(a)for use in the treatment of another person; or

(b)for use solely for experimental purposes in humans.

(2)An approval under subsection (1)—

(a)is subject to the conditions specified in the approval; and

(b)may include a condition relating to the charges that may be made for the supply of the therapeutic goods to which the approval relates.

(3)An application for an approval must be made to the Secretary and—

(a)in the case of an application for use of the kind referred to in subsection (1)(a), must be accompanied by such information relating to the goods that the Secretary requires; and

s. 8

(b)in the case of an application for use of the kind referred to in subsection (1)(b)—

(i)must be made in writing; and

(ii)must be accompanied by such information relating to the goods that the Secretary requires; and

(iii)must be accompanied by a fee which is an amount equal to the evaluation fee prescribed for the purposes of section 19(2)(b)(iii) of the Commonwealth Act.

(4)If an application for an approval is made, the Secretary must notify the applicant of his or her decision on the application within 28 days of making the decision and, in the case of a decision not to grant the approval, of the reasons for the decision.

(5)The Secretary may, in writing, authorise an approved medical practitioner to supply—

(a)specified therapeutic goods for use in the treatment of humans; or

(b)a specified class of such goods—

to the class or classes of recipients specified in the authority, being a class or classes of recipients to whom therapeutic goods of that kind may be supplied in accordance with an authority under section 19(5) of the Commonwealth Act.