Therapeutic Goods Act 1966 (Cth)
THERAPEUTIC GOODS ACT 1966 [Note: This Act is "repealed" by Act No. 21 of 1990]
(#DATE 31:05:1983)
(#DATE 31:05:1983)
- Reprinted as at 31 May 1983
29, 1966 amended as indicated in the Tables below.
(The citation "Therapeutic Goods Act 1966" is provided for by the
Amendments Incorporation Act 1905 and the Acts Citation Act 1976.)
Table of Acts
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Application,
saving or Number Date Date of transitional
Act and year of Assent commencement provisions
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Therapeutic Goods
Act 1966 29, 1966 24 May
1966 12 Nov 1970 (see
Gazette 1970, p.
7655)
Statute Law Revision
Act 1973 216, 1973 19 Dec
1973 31 Dec 1973 Ss. 9 (1)
and 10
Health Acts
Amendment Act 1981 118, 1981 25 June
1981 Part V (ss.
81-97):
1 Apr 1982
(see Gazette
1982, No. G12,
p. 3) (a) S. 94 (2)
Statute Law
(Miscellaneous
Amendments) Act (No.
2) 1982 80, 1982 22 Sept
1982 Part LXXV (ss.
270-277): 20 Oct
1982 (b) S. 274 (2)
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(a) The Therapeutic Goods Act 1966 was amended by Part V (sections 81-97)
only of the Health Acts Amendment Act 1981, sub-section 2 (5) of which provides
that Part V shall come into operation on a date to be fixed by Proclamation.
(b) The Therapeutic Goods Act 1966 was amended by Part LXXV (sections
270-277) only of the Statute Law (Miscellaneous Amendments) Act (No. 2) 1982,
sub-section 2 (16) of which provides that Part LXXV shall come into operation on the twenty-eighth day after Royal Assent.
Table of Amendments
ad. E added or inserted am. E amended rep. E repealed rs. E repealed and
substituted
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Provision affected How affected
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Ss. 3, 4 . . . . . . . rep. No. 216, 1973
S. 5 . . . . . . . am. No. 118, 1981; No. 80, 1982
S. 6 . . . . . . . rs. No. 118, 1981
S. 8 . . . . . . . am. No. 118, 1981
S. 9 . . . . . . . am. No. 216, 1973; No. 118, 1981
S. 10 . . . . . . am. No. 118, 1981
S. 11 . . . . . . am. No. 118, 1981; No. 80, 1982
S. 12 . . . . . . am. No. 118, 1981
S. 13 . . . . . . am. No. 118, 1981; No. 80, 1982
S. 14 . . . . . . am. No. 118, 1981
rep. No. 80, 1982
S. 15 . . . . . . am. No. 118, 1981
S. 15A . . . . . . ad. No. 80, 1982
S. 16A . . . . . . ad. No. 118, 1981
am. No. 80, 1982
Ss. 19-21 . . . . am. No. 118, 1981
S. 22 . . . . . . am. No. 216, 1973; No. 118, 1981
S. 23 . . . . . . am. No. 118, 1981
Part IIIA (ss.
23A-23G) . . . . . ad. No. 118, 1981
Ss. 23A-23G . . . ad. No. 118, 1981
Part IIIB (ss.
23H-23M) . . . . . ad. No. 118, 1981
Ss. 23H-23M . . . ad. No. 118, 1981
S. 24 . . . . . . am. No. 216, 1973; No. 118, 1981
S. 25 . . . . . . am. No. 118, 1981
Ss. 25A, 25B . . . ad. No. 118, 1981
S. 26 . . . . . . am No. 118, 1981
S. 26A . . . . . . ad. No. 118, 1981
S. 27 . . . . . . rs. No. 118, 1981
S. 28 . . . . . . am. No. 216, 1973
S. 29 . . . . . . am. No. 118, 1981
S. 29A . . . . . . ad. No. 118, 1981
rs. No. 80, 1982
S. 30 . . . . . . am. No. 118, 1981
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THERAPEUTIC GOODS ACT 1966 - TABLE OF PROVISIONS TABLE
TABLE OF PROVISIONS PART I-PRELIMINARY
Section
1. Short title
2. Commencement
5. Interpretation
6. Editions of British Pharmacopoeia having effect for the purposes of
this Act
7. Mixtures
8. Certification of goods not intended for therapeutic use
9. Furnishing of information with respect to composition of goods
10. Labelling and packaging requirements in British Pharmacopoeia
PART II-DETERMINATION OF STANDARDS
11. Determination of standards for specific goods
12. Modifications of monographs by Minister
13. Determination of general standards
15. Determination of requirements with respect to labelling, packing and
containers
15A. Instruments may contain several orders
16. Effect of orders in relation to goods for human use or veterinary use
16A. Mode of specifying standards, &c.
17. Amendment and revocation of orders
18. Notification of orders in Gazette, &c.
PART III-GOODS TO CONFORM TO STANDARDS
19. Importation of goods for therapeutic use
20. Interstate trade
21. Pharmaceutical benefits
22. Supply to the Commonwealth of goods for therapeutic use
23. Consent of Minister
PART IIIA-BIOLOGICAL PRODUCTS
23A. Interpretation
23B. Additional operation of Part
23C. Object of Part
23D. General information to be provided on manufacturing and testing
procedures
23E. Information to be provided in relation to particular batches
23F. Prescribed methods of manufacturing and testing
23G. Manufacturers to keep records
PART IIIB-NATIONAL REGISTER OF THERAPEUTIC GOODS
23H. Interpretation
23J. Additional operation of Part
23K. Object of Part
23L. National Register of Therapeutic Goods
23M. Director-General may obtain information
PART IV-MISCELLANEOUS
24. Regulations may provide for the examination, &c., of goods for
therapeutic use
25. Offences-General
25A. Prosecution of offences
25B. Continuing offences
26. Judicial notice
26A. Service of notices
27. Delegation
28. Saving of other laws
29. Dangerous substances
29A. Applications for review
30. Regulations
THERAPEUTIC GOODS ACT 1966 - LONG TITLE SECT
An Act to make provision for and in relation to Standards for Goods for Therapeutic Use, and for other purposes
THERAPEUTIC GOODS ACT 1966 - SECT. 1.
Short titleSECT
PART I-PRELIMINARY
1. This Act may be cited as the Therapeutic Goods Act 1966.*1*
See notes to first article of this CHAPTER.
THERAPEUTIC GOODS ACT 1966 - SECT. 2.
CommencementSECT
2. This Act shall come into operation on a date to be fixed by Proclamation.*1*
See notes to first article of this CHAPTER.
THERAPEUTIC GOODS ACT 1966 - SECT. 5.
InterpretationSECT
5. (1) In this Act, unless the contrary intention appears-
"batch" includes a number of batches and a part of a batch;
"British Pharmaceutical Codex" means the book called the British Pharmaceutical Codex published by direction of the Council of the Pharmaceutical Society of Great Britain;
"British Pharmacopoeia" means-
(a) the latest edition (being an edition that has taken effect for the purposes of this Act in accordance with section 6) for the time being of the book called the British Pharmacopoeia published on the recommendation of the Medicines Commission of the United Kingdom; or
(b) if that edition has been added to or amended by additions or amendments that have taken effect for the purposes of this Act in accordance with section 6-that edition as affected by those additions or amendments;
"British Pharmacopoeia (Veterinary)" means the book called the British Pharmacopoeia (Veterinary) published on the recommendation of the Medicines Commission of the United Kingdom;
"British Veterinary Codex" means the book called the British Veterinary Codex published by direction of the Council of the Pharmaceutical Society of Great Britain;
"Director-General" means the Director-General of Health;
"European Pharmacopoeia" means the book called the European Pharmacopoeia published in accordance with the terms of the convention known as the Convention on the Elaboration of a European Pharmacopoeia;
"former British Pharmacopoeia" means the book called the British Pharmacopoeia published under the direction of the General Medical Council of the United Kingdom;
"general standard", in relation to goods for therapeutic use, means a standard specified in an order made under section 13 that applies to a substance or article of which the goods consist, or are represented to consist, and-
(a) if the goods are for human use-has effect in relation to goods for human use; or
(b) if the goods are for veterinary use-has effect in relation to goods for veterinary use;
"goods for therapeutic use" means goods that-
(a) are (whether by writing or otherwise) represented to be, or are (whether by reason of the way in which the goods are put up or for any other reason) likely to be taken to be-
(i) for therapeutic use;
(ii) for use as an ingredient or component in the preparation or manufacture of a substance or article for therapeutic use; or
(iii) for use as a container, or as part of a container, of a substance or article for therapeutic use or use of a kind referred to in sub-paragraph (ii); or
(b) are included in a class of goods the sole or principal use of which is, or ordinarily is, a therapeutic use or use of a kind referred to in sub-paragraph (a) (ii) or (iii),
but does not include-
(c) goods in respect of which a certificate has been issued under section 8; or
(d) goods consisting of a vaccine prepared from microscopic organisms from the body of a person or animal for use only in the treatment of that person or animal;
"labelling and packaging requirements", in relation to goods for therapeutic use, means requirements specified in an order made under section 15 that applies to a substance or article of which the goods consist, or are represented to consist, and-
(a) if the goods are for human use-has effect in relation to goods for human use; or
(b) if the goods are for veterinary use-has effect in relation to goods for veterinary use;
"order" means an order made by the Minister under Part II;
"orthotics" means the complementing, supplementing or replacing of a physiological function of the body and includes the provision of contact lenses, hearing aids, heart pace-makers and similar aids;
"Pharmaceutical Codex" means the book called the Pharmaceutical Codex published by direction of the Council of the Pharmaceutical Society of Great Britain;
"prescribed corporation" means a foreign corporation, or a trading corporation formed within the limits of the Commonwealth, within the meaning of paragraph 51 (xx) of the Constitution;
"prescribed publication" means-
(a) the British Pharmaceutical Codex;
(b) the British Pharmacopoeia (Veterinary);
(c) the British Veterinary Codex;
(d) the former British Pharmacopoeia; or
(e) the Pharmaceutical Codex;
"prosthetics" means the making up of a deficiency in the body and includes the provision of dentures, artificial organs or limbs or similar aids;
"relevant date" means the date of commencement of Part V of the Health Acts Amendment Act 1981;
"specific standard", in relation to goods for therapeutic use, means a standard for a substance or article of which the goods consist, or are represented to consist, that-
(a) if the goods are for human use-
(i) is specified in an order under section 11 that has effect in relation to goods for human use; or
(ii) where a standard for the substance or article is not specified in such an order but the substance or article is the subject of a monograph in the British Pharmacopoeia-is constituted by the statements in that monograph; or
(b) if the goods are for veterinary use-is specified in an order under section 11 that has effect in relation to goods for veterinary use;
"substance" includes a mixture or compound of substances;
"supply" includes-
(a) supply by way of sale, exchange, gift, lease, hire or hire-purchase;
(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 research undertaken to test the safety or efficacy of goods for therapeutic use;
"therapeutic use" means use in, or in connection with-
(a) the preventing, diagnosing, curing or alleviating of a disease, ailment, defect or injury in persons or animals;
(b) the influencing, inhibiting or modifying of a physiological process in persons or animals; or
(c) the testing of the susceptibility of persons or animals to a disease or ailment,
and, without limiting the generality of the foregoing, includes use in, or in connection with, testing for pregnancy, contraception, prosthetics or orthotics.
(2) For the purposes of this Act, goods for therapeutic use shall be deemed to be represented to consist, either in whole or in part, of a particular substance or a particular article if-
(a) the goods bear a name or description-
(i) that is, or is likely to be taken for, a name or description of the substance or article; or
(ii) that is likely to cause the goods to be taken to consist, in whole or in part, of that substance or article;
(b) the Minister or another person is informed, in pursuance of a notice under section 9, that the goods consist, in whole or in part, of that substance or article; or
(c) the goods are otherwise represented, by writing or otherwise, or otherwise purport, to consist, in whole or in part, of that substance or article.
(3) For the purposes of this Act-
(a) goods shall be deemed to be for veterinary use if-
(i) the goods bear any particulars that constitute, or are likely to be taken for, a statement that the goods are intended for veterinary use and are not intended for human use; or
(ii) the goods are otherwise represented, by writing or otherwise, or otherwise purport, to be intended for veterinary use and not to be intended for human use; and
(b) goods shall be deemed to be for human use if they are not for veterinary use.
(4) For the purposes of sub-sections (2) and (3), goods shall be deemed to bear a name, description or other particulars if that name, that description or those particulars, as the case may be, are set out on-
(a) the goods or any part of the goods;
(b) a container or package containing the goods or any part of the goods;
(c) a label affixed or attached to the goods or any part of the goods; or
(d) a label affixed or attached to, or inserted in, a container or package containing the goods or any part of the goods.
(5) Where a statement in a monograph in a publication refers to a statement in a monograph in another publication, the statement in the monograph in the other publication shall be deemed to be a statement in the first-mentioned monograph.
(6) A monograph in the British Pharmacopoeia that purports to reproduce statements in a monograph in the European Pharmacopoeia shall not be construed for the purposes of this Act by reference to the monograph in the European Pharmacopoeia notwithstanding anything to the contrary in the British Pharmacopoeia.
(7) A reference in this Act to a book, other than the British Pharmacopoeia, shall be read as a reference to any edition of that book, whether published before or after the relevant date, or any such edition as added to or amended by any addition to or amendment of that edition.
(8) A reference in this Act to goods for therapeutic use does not include a reference to goods for use in, or in connection with, testing for pregnancy, contraception, prosthetics or orthotics unless the goods are declared, or are included in a class of goods that are declared, by the regulations to be goods for therapeutic use to which this Act applies.
THERAPEUTIC GOODS ACT 1966 - SECT. 6.
Editions of British Pharmacopoeia having effect for the purposes of this ActSECT
6. The edition of the British Pharmacopoeia that was published in 1973 shall be deemed to have taken effect for the purposes of this Act on the relevant date, and any additions to, or amendments of, that edition (whether made before or after the relevant date), any subsequent edition of the British Pharmacopoeia and any additions to, or amendments of, any subsequent edition shall take effect for the purposes of this Act upon such dates as are respectively fixed by the Minister by notices published in the Gazette.
THERAPEUTIC GOODS ACT 1966 - SECT. 7.
MixturesSECT
7. (1) Where-
(a) goods consist, or are represented to consist, of a mixture of substances; and
(b) there is a specific standard applicable to the goods in relation to the mixture,
any specific standard that is applicable to the goods in relation to a substance included in the mixture shall be disregarded.
(2) Where-
(a) goods consist, or are represented to consist, of a mixture of substances;
(b) there is no specific standard applicable to the goods in relation to the mixture but there is a specific standard applicable to the goods in relation to a substance included in the mixture; and
(c) the Minister, by instrument in writing, has directed that this Act does not apply to that substance when it is part of a mixture of that kind,
the specific standard so applicable to the goods shall be disregarded.
(3) Where-
(a) goods consist, or are represented to consist, of a mixture of substances; and
(b) there is, with respect to any matter, a general standard applicable to the goods in relation to the mixture,
any general standard with respect to that matter that is applicable to the goods in relation to a substance included in the mixture shall be disregarded.
(4) In this section, "substance" includes article.
THERAPEUTIC GOODS ACT 1966 - SECT. 8.
Certification of goods not intended for therapeutic useSECT
8. (1) Where a person satisfies a person authorized by the Minister to issue certificates under this section that goods are not intended for therapeutic use, the person so authorized may issue to the other person a certificate that this Act does not apply to the goods.
(2) A certificate under sub-section (1) may be issued unconditionally or subject to conditions.
(3) Where a condition subject to which a certificate under this section is issued is not complied with, the person to whom the certificate was issued shall be deemed to have committed an offence against this Act.
THERAPEUTIC GOODS ACT 1966 - SECT. 9.
Furnishing of information with respect to composition of goodsSECT
9. (1) The Minister may, by notice in writing served on a person who-
(a) has imported goods for therapeutic use into Australia;
(b) has caused goods for therapeutic use to become the subject of trade or commerce among the States;
(c) has, under a law of the Commonwealth relating to the provision of pharmaceutical benefits, supplied goods for therapeutic use as a pharmaceutical benefit; or
(d) has supplied goods for therapeutic use to the Commonwealth or the Northern Territory or to an authority of the Commonwealth or a Territory,
direct the person to furnish, in writing, to the Minister or another person specified in the notice, within such period as is so specified, such information with respect to the composition of the goods as is required by the notice.
(2) A person shall not fail to comply with a notice served on him under this section.
Penalty: $200.
(2A) A person shall not, in purported compliance with a notice served on him under this section, knowingly furnish information that is false or misleading in a material particular.
Penalty: $2,000.
(3) A person is not excused from furnishing information in pursuance of a notice served on him under this section on the ground that the information might tend to incriminate him, but his furnishing of any information in pursuance of the notice is not admissible in evidence against him in any criminal proceedings, other than proceedings under sub-section (2A).
THERAPEUTIC GOODS ACT 1966 - SECT. 10.
Labelling and packaging requirements in British PharmacopoeiaSECT
10. (1) Subject to sub-section (2), where-
(a) a specific standard applicable to goods for therapeutic use is a standard constituted by statements in a monograph in the British Pharmacopoeia;
(b) requirements applicable to the labelling or packing of the goods are specified in the British Pharmacopoeia; and
(c) the goods are not labelled or packed in accordance with those requirements,
the goods shall, for the purposes of this Act, be deemed not to conform to that standard.
(2) Where-
(a) an order made under section 15 applies to the labelling or packing of goods;
(b) requirements applicable to the labelling or packing of the goods are specified in the British Pharmacopoeia; and
(c) the requirements referred to in paragraph (b) are inconsistent with the requirements specified in the order,
then, in relation to the goods, the requirements referred to in paragraph (b) shall, to the extent of the inconsistency, for the purposes of the section of this Act for the purposes of which the order was made, be disregarded.
THERAPEUTIC GOODS ACT 1966 - SECT. 11.
Determination of standards for specific goodsSECT
PART II-DETERMINATION OF STANDARDS
11. (1) The Minister may, by order in writing, determine that the standard for a substance or article the name of which is specified in the order (including a substance or article that is the subject of a monograph in the British Pharmacopoeia is, for the purposes of this Act, the standard so specified.
(2) The standard may be specified in such manner as the Minister thinks fit, and, without limiting the generality of the foregoing, may be specified by reference to any one or more of the following, that is to say, the composition, strength, potency, stability, sterility, quantity, quality or method of preparation of a substance or article.
(3) Without limiting the generality of sub-section (1), the Minister may, in an order made under this section specifying a standard for a substance or article, specify that a matter relating to the standard is to be determined in accordance with a test specified in the order.
THERAPEUTIC GOODS ACT 1966 - SECT. 12.
Modifications of monographs by MinisterSECT
12. (1) The Minister may, by order in writing, determine that a monograph in the British Pharmacopoeia shall, for the purposes of this Act, be deemed to be modified in such manner as is specified in the order.
(2) A reference in this Act to a monograph in the British Pharmacopoeia shall, if an order under sub-section (1) is in force in relation to the monograph, be read as a reference to the monograph as deemed to be modified in the manner specified in the order.
THERAPEUTIC GOODS ACT 1966 - SECT. 13.
Determination of general standardsSECT
13. (1) The Minister may, by order in writing, determine that, with respect to a matter that is a prescribed matter, the standard for a substance or article to which the order applies is, for the purposes of this Act, the standard specified in the order.
(2) An order under sub-section (1) may be expressed to apply to substances generally, articles generally or to a class of substances or articles specified in the order.
(2A) Without limiting the generality of sub-section (1), the Minister may, in an order made under this section specifying, with respect to a matter that is a prescribed matter, a standard for a substance or article, specify that the matter is to be determined in accordance with a test specified in the order.
(3) Where a general standard applicable to goods is inconsistent with a specific standard applicable to the goods, the general standard, in relation to the goods, is, to the extent of the inconsistency, of no effect.
(4) In this section, "prescribed matter" means composition, strength, potency, stability, sterility, quantity, quality, method of preparation or any other matter prescribed by the regulations.
THERAPEUTIC GOODS ACT 1966 - SECT. 15.
Determination of requirements with respect to labelling, packing and
containersSECT
15. (1) The Minister may, by order in writing, for the purposes of a section of this Act specified in the order, direct that goods consisting of a substance or article to which the order applies shall be labelled in such manner as is specified in the order.
(2) The Minister may, by order in writing, for the purposes of a section of this Act specified in the order, direct that goods consisting of a substance or article to which the order applies shall be packed in such manner as is specified in the order.
(3) The Minister may, by order in writing, for the purposes of a section of this Act specified in the order, direct that goods consisting of a substance or article to which the order applies shall be in containers that comply with such requirements as are specified in the order.
(4) An order under this section may be expressed to apply to substances generally, articles generally, a class of substances or articles specified in the order or a substance or article the name of which is so specified.
(5) Without limiting the generality of sub-section (1), the Minister may, in an order made under that sub-section, direct that there shall, in such manner, if any, as is specified in the order, be set out on-
(a) goods consisting of a substance or article to which the order applies;
(b) a container or package containing goods consisting of a substance or article to which the order applies;
(c) a label affixed or attached to goods consisting of a substance or article to which the order applies; or
(d) a label affixed or attached to, or inserted in, a container or package containing goods consisting of a substance or article to which the order applies,
such particulars as are required by the order.
THERAPEUTIC GOODS ACT 1966 - SECT. 15A.
Instruments may contain several ordersSECT
15A. Nothing in this Act prevents the making of 2 or more orders under this Act by a single instrument.
THERAPEUTIC GOODS ACT 1966 - SECT. 16.
Effect of orders in relation to goods for human use or veterinary useSECT
16. Unless the contrary intention appears in an order, the order has effect in relation to goods for human use and goods for veterinary use.
THERAPEUTIC GOODS ACT 1966 - SECT. 16A.
Mode of specifying standards, &c.SECT
16A. (1) The Minister may specify a standard in relation to goods for therapeutic use in pursuance of section 11, 13 or 15-
(a) by setting out in the order specifying the standard the statements that are to constitute the standard;
(b) by reference to a monograph in-
(i) a prescribed publication;
(ii) the European Pharmacopoeia;
(iii) a publication of the organization known as the Standards Association of Australia; or
(iv) any other publication that the Minister is satisfied is a proper source for the standard; or
(c) by reference to a monograph in the British Pharmacopoeia or in a publication referred to in paragraph (b), being that monograph as modified in such manner as is specified in the order specifying the standard.
(2) Where a standard is specified in the manner referred to in paragraph (1) (b), the standard shall be constituted by the statements in the monograph.
(3) Where a standard is specified in the manner referred to in paragraph (1) (c), the standard shall be constituted by the statements in the monograph as modified in the manner specified in the order specifying the standard.
(4) The Minister shall not be satisfied for the purposes of sub-paragraph (1) (b) (iv) that a publication is a proper source for a standard unless he has been advised that the publication is such a source by a committee in respect of which a declaration under sub-section (5) was in force at the time when the advice was given.
(5) Where the Minister is satisfied that a committee established by the regulations is so constituted that it would be appropriate for it to give advice to him with respect to standards in relation to goods for therapeutic use, he may, by writing signed by him, declare that committee to be a therapeutic goods standards committee for the purposes of this section.
(6) In this section, unless the contrary intention appears, "standard" includes a test and a labelling and packaging requirement.
THERAPEUTIC GOODS ACT 1966 - SECT. 17.
Amendment and revocation of ordersSECT
17. The Minister may, by order in writing, amend or revoke an order made under a preceding provision of this Part.
THERAPEUTIC GOODS ACT 1966 - SECT. 18.
Notification of orders in Gazette, &c.SECT
18. (1) The making of an order shall be notified in the Gazette.
(2) An order takes effect from the date of notification of the making of the order in the Gazette or from such later date, if any, as is specified in the order.
(3) The notification in the Gazette of the making of an order shall include a statement of the place where copies of the order can be obtained.
(4) Orders are not Statutory Rules within the meaning of the Rules Publication Act 1903-1964.*2*
*2* S. 18 (4)-Now cited as the Statutory Rules Publication Act 1903.
THERAPEUTIC GOODS ACT 1966 - SECT. 19.
Importation of goods for therapeutic useSECT
PART III-GOODS TO CONFORM TO STANDARDS
19. (1) The importation into Australia is prohibited of goods for therapeutic use that-
(a) do not conform to any specific standard applicable to the goods;
(b) do not conform to any general standard applicable to the goods; or
(c) do not comply with any labelling and packaging requirements applicable to the goods and having effect by virtue of an order made under section 15 for the purposes of this section.
(2) Goods the importation of which is prohibited under sub-section (1) are prohibited imports for the purposes of the Customs Act 1901-1966, and the provisions of that Act relating to prohibited imports apply accordingly.
(3) Where the Minister is satisfied that it is not against the public interest so to do, he may, by instrument in writing and subject to such conditions, if any, as are specified in the instrument, exempt from sub-section (1) the importation by a person specified in the instrument-
(a) of the goods specified in the instrument; or
(b) of goods to be used for a purpose specified in the instrument.
(4) Where a condition specified in an instrument of exemption under this section is not complied with, the person in whose favour the exemption was granted shall be deemed to have committed an offence against this Act.
THERAPEUTIC GOODS ACT 1966 - SECT. 20.
Interstate tradeSECT
20. Except with the consent in writing of the Minister, a person shall not cause, suffer or permit goods for therapeutic use to become the subject of trade or commerce among the States unless the goods-
(a) conform to any specific standard applicable to the goods;
(b) conform to any general standard applicable to the goods; and
(c) comply with any labelling and packaging requirements applicable to the goods and having effect by virtue of an order made under section 15 for the purposes of this section.
THERAPEUTIC GOODS ACT 1966 - SECT. 21.
Pharmaceutical benefitsSECT
21. (1) Except with the consent in writing of the Minister, a person shall not, under a law of the Commonwealth relating to the provision of pharmaceutical benefits, supply as a pharmaceutical benefit goods for therapeutic use unless-
(a) the goods-
(i) conform to any specific standard applicable to the goods;
(ii) conform to any general standard applicable to the goods; and
(iii) comply with any labelling and packaging requirements applicable to the goods and having effect by virtue of an order made under section 15 for the purposes of this section; and
(b) goods used as an ingredient in the preparation of the goods-
(i) conform to any specific standard applicable to the goods so used; and
(ii) conform to any general standard applicable to the goods so used.
(2) Where a person supplies goods as a pharmaceutical benefit under a law of the Commonwealth relating to the provision of pharmaceutical benefits in contravention of this section, that supply shall, for the purposes of that law, be deemed not to be a supply of a pharmaceutical benefit in accordance with that law.
THERAPEUTIC GOODS ACT 1966 - SECT. 22.
Supply to the Commonwealth of goods for therapeutic useSECT
22. Except with the consent in writing of the Minister, a person shall not supply to the Commonwealth or the Northern Territory or to an authority of the Commonwealth or of a Territory goods for a therapeutic use unless the goods-
(a) conform to any specific standard applicable to the goods;
(b) conform to any general standard applicable to the goods; and
(c) comply with any labelling and packaging requirements applicable to the goods and having effect by virtue of an order made under section 15 for the purposes of this section.
THERAPEUTIC GOODS ACT 1966 - SECT. 23.
Consent of MinisterSECT
23. (1) The consent of the Minister for the purposes of section 20, 21 or 22 may be given either unconditionally or subject to conditions.
(2) Where a condition subject to which such a consent is given is not complied with, the person in whose favour the consent was given shall be deemed to have committed an offence against this Act.
THERAPEUTIC GOODS ACT 1966 - SECT. 23A.
InterpretationSECT
PART IIIA-BIOLOGICAL PRODUCTS
23A. (1) In this Part, unless the contrary intention appears-
"biological product" means goods for therapeutic use that are, are produced from, or the production of which involves the use of, organisms or the tissue or body fluids of organisms, and includes vaccines and toxoids, but does not include antibiotics or products derived from plants, other than antibiotics or such products that are used as antigens or haptens;
"manufacturing corporation" means a prescribed corporation that produces, or proposes to produce, biological products;
"procedures", in relation to the production of a biological product, includes testing procedures in relation to the production of the product, whether carried out during, or after the completion of, the production of the product.
(2) Nothing in this Part shall be taken as limiting the operation of the other Parts of this Act in relation to biological products.
THERAPEUTIC GOODS ACT 1966 - SECT. 23B.
Additional operation of PartSECT
23B. Without prejudice to its effect apart from this section, this Part also has, by force of this section, the effect it would have if-
(a) any references in sections 23D, 23E, 23F and 23G to the production in Australia of biological products were, by express provision, confined to-
(i) the production in Australia of those products for supply-
(A) in the course of trade or commerce among the States, between a State and a Territory or between two Territories;
(B) under a law of the Commonwealth relating to the provision of pharmaceutical benefits;
(C) to the Commonwealth or the Northern Territory or to an authority of the Commonwealth or of a Territory; or
(D) in an internal Territory; or
(ii) the production of those products in an internal Territory;
(b) any references in those sections to the supply in Australia of biological products were, by express provision, confined to-
(i) the supply in Australia of biological products-
(A) in the course of trade or commerce among the States, between a State and a Territory or between two Territories;
(B) under a law of the Commonwealth relating to the provision of pharmaceutical benefits; or
(C) to the Commonwealth or the Northern Territory or to an authority of the Commonwealth or of an internal Territory; or
(ii) the supply of biological products in an internal Territory; and
(c) any references in those sections to a manufacturing corporation included a reference to a person, not being a prescribed corporation, who produces, or proposes to produce, biological products.
THERAPEUTIC GOODS ACT 1966 - SECT. 23C.
Object of PartSECT
23C. The object of this Part is to ensure, so far as the Constitution permits, the safety, quality and efficacy of biological products that are supplied in Australia or produced in Australia.
THERAPEUTIC GOODS ACT 1966 - SECT. 23D.
General information to be provided on manufacturing and testing proceduresSECT
23D. (1) The Director-General may, by notice in writing served on a manufacturing corporation, require the manufacturing corporation to furnish to him such information in writing as is required by the notice with respect to the procedures carried out, or to be carried out, by the manufacturing corporation in the production in Australia of a biological product specified in the notice.
(2) Where the Director-General has, by notice under sub-section (1), required a manufacturing corporation to furnish to him information in writing with respect to the production in Australia of a biological product, the manufacturing corporation shall not produce in Australia that biological product, or supply in Australia that biological product to another person, unless-
(a) the manufacturing corporation has furnished the information required; or
(b) the Director-General has, upon application in writing made to him by the manufacturing corporation or on his own initiative, authorized the manufacturing corporation, by notice in writing served on the manufacturing corporation, to produce that biological product or to supply that biological product to other persons and that notice is in force at the time when the manufacturing corporation produces that biological product or supplies that biological product to that other person, as the case requires.
(3) The Director-General may, where he considers it appropriate to do so, include in a notice under sub-section (1) a direction that the manufacturing corporation shall comply with sub-section (4) in relation to a biological product to which the notice relates.
(4) Where-
(a) a manufacturing corporation has been served with a notice under sub-section (1) that contained a direction referred to in sub-section (3) in relation to a biological product; and
(b) the manufacturing corporation has, in accordance with the requirement in that notice, furnished information with respect to the procedures carried out, or to be carried out, by the manufacturing corporation in the production in Australia of that biological product,
the manufacturing corporation shall not-
(c) produce in Australia that biological product in accordance with procedures that differ from the procedures specified in the information furnished; or
(d) supply in Australia to another person that biological product if that biological product has been produced in accordance with procedures that differ from the procedures specified in the information furnished,
unless the manufacturing corporation has, not less than 28 days before commencing to produce that biological product, furnished to the Director-General information, in writing, with respect to the procedures to be carried out by the manufacturing corporation in the production of that biological product.
(5) The Director-General may, by notice in writing served on a manufacturing corporation that has been served with a notice under paragraph (2) (b), revoke that last-mentioned notice.
THERAPEUTIC GOODS ACT 1966 - SECT. 23E.
Information to be provided in relation to particular batchesSECT
23E. (1) The Director-General may, by notice in writing served on a manufacturing corporation, require the manufacturing corporation to furnish to him such information in writing, records or samples as are required by the notice with respect to the procedures carried out, or to be carried out, by the manufacturing corporation in the production in Australia of a specified batch or other quantity of a special biological product.
(2) Where, in accordance with a requirement in a notice under sub-section (1), a manufacturing corporation has furnished to the Director-General information in writing, records or samples with respect to the procedures carried out in the production in Australia of a specified batch or other quantity of a biological product, the Director-General may, by notice in writing served on the manufacturing corporation, direct the manufacturing corporation not to supply in Australia to any person any part of that batch or other quantity of the biological product.
(3) Where, in accordance with a requirement in a notice under sub-section (1), a manufacturing corporation has furnished to the Director-General information in writing, records or samples with respect to the procedures to be carried out in the production in Australia of a specified batch or other quantity of a biological product, the Director-General may-
(a) by notice in writing served on the manufacturing corporation, direct the manufacturing corporation not to take any step or further step in the production in Australia of any part of that batch or other quantity of the biological product; or
(b) by notice in writing served on the manufacturing corporation, direct the manufacturing corporation not to supply in Australia to any person any part of that batch or other quantity of the biological product.
(4) Where a manufacturing corporation has, by notice under sub-section (1), been required to furnish information in writing, records or samples with respect to the procedures carried out in the production in Australia of a specified batch or other quantity of a biological product, the manufacturing corporation shall not supply in Australia to another person any part of that batch or other quantity of the biological product unless the manufacturing corporation has furnished the information, records or samples required.
(5) Where, in accordance with a requirement in a notice under sub-section (1), a manufacturing corporation has furnished to the Director-General information in writing, records or samples with respect to the procedures carried out in the production in Australia of a specified batch or other quantity of a biological product, the manufacturing corporation shall not-
(a) in a case where the Director-General has served notice on the manufacturing corporation under sub-section (2) in relation to that batch or other quantity of the biological product-supply in Australia to another person any part of that batch or other quantity of the biological product unless the Director-General has, upon application in writing made to him by the manufacturing corporation or on his own initiative, authorized the manufacturing corporation, by notice in writing served on the manufacturing corporation, to supply to other persons that batch or other quantity of the biological product and that notice is in force at the time when the manufacturing corporation supplies that part of that batch or other quantity of the biological product to that other person; or
(b) in any other case-supply in Australia to another person any part of that batch or other quantity of the biological product unless a period of 28 days has elapsed since the manufacturing corporation furnished the information, records or samples.
(6) Where a manufacturing corporation has, by notice, under sub-section (1), been required to furnish information in writing, records or samples with respect to the procedures to be carried out in the production in Australia of a specified batch or other quantity of a biological product, the manufacturing corporation shall not take any step or further step in the production in Australia of any part of that batch or other quantity of the biological product unless the manufacturing corporation has furnished the information, records or samples required.
(7) Where, in accordance with a requirement in a notice under sub-section (1), a manufacturing corporation has furnished to the Director-General information in writing, records or samples with respect to the procedures to be carried out in the production in Australia of a specified batch or other quantity of a biological product, the manufacturing corporation shall not-
(a) in the case where the Director-General has served notice on the manufacturing corporation under paragraph (3) (a) in relation to that batch or other quantity of the biological product-take any step or further step in the production in Australia of any part of that batch or other quantity of the biological product unless the Director-General has, upon application in writing made to him by the manufacturing corporation or on his own initiative, authorized the manufacturing corporation, by notice in writing served on the manufacturing corporation, to produce that batch or other quantity of the biological product and that notice is in force at the time when the manufacturing corporation takes that step or further step in the production of that part of that batch or other quantity of the biological product;
(b) in a case where the Director-General has served notice on the manufacturing corporation under paragraph (3) (b) in relation to that batch or other quantity of the biological product-supply in Australia to another person any part of that batch or other quantity of the biological product unless the Director-General has, upon application in writing made to him by the manufacturing corporation, or on his own initiative, authorized the manufacturing corporation, by notice in writing served on the manufacturing corporation, to supply to other persons that batch or other quantity of the biological product and that notice is in force at the time when the manufacturing corporation supplies that part of that batch or other quantity of the biological product to that other person; or
(c) in any other case-take any step or further step in the production in Australia of any part of that batch or other quantity of the biological product unless a period of 28 days has elapsed since the manufacturing corporation furnished the information, records or samples.
(8) Where a manufacturing corporation has been served with a notice under sub-section (2) or paragraph (3) (a) or (b), the Director-General may, upon application in writing made to him by the manufacturing corporation or on his own initiative, revoke that notice by notice in writing served on the manufacturing corporation.
(9) The Director-General may, by notice in writing served on a manufacturing corporation that has been served with a notice under paragraph (5) (a), (7) (a) or (7) (b), revoke that last-mentioned notice.
THERAPEUTIC GOODS ACT 1966 - SECT. 23F.
Prescribed methods of manufacturing and testingSECT
23F. (1) The Minister may, by order in writing, determine the procedures to be carried out in the production in Australia of a biological product specified in the order.
(2) Where, in pursuance of sub-section (1), procedures are determined in relation to the production in Australia of a biological product-
(a) a manufacturing corporation shall not supply in Australia that biological product to another person unless that biological product has been produced in accordance with those procedures; and
(b) a person shall not import, without the authority in writing of the Director-General, that biological product into Australia unless that biological product has been produced in accordance with those procedures.
(3) Without limiting the generality of sub-section (1), the Minister may determine procedures under that sub-section by reference to a monograph in the British Pharmacopoeia or in a publication referred to in paragraph 16A (1) (b), with or without modification of that monograph.
(4) Sections 16, 17 and 18 apply to an order made under sub-section (1) of this section as if it were an order made under Part II.
THERAPEUTIC GOODS ACT 1966 - SECT. 23G.
Manufacturers to keep recordsSECT
23G. (1) The Director-General may, by notice in writing served on a manufacturing corporation, require the manufacturing corporation to keep such records as are specified in the notice with respect to the procedures carried out by the manufacturing corporation in relation to the production in Australia of each batch or other quantity of a biological product specified in the notice that the manufacturing corporation produces after the date on which the notice is served.
(2) The Director-General may, by notice in writing served on a manufacturing corporation required to keep records in pursuance of a notice under sub-section (1), require that manufacturing corporation to furnish to the Director-General such of those records, or copies of such of those records, as are specified in the notice under this sub-section.
(3) The Director-General may, by notice in writing served on a manufacturing corporation that has been served with a notice under sub-section (1), amend or revoke that notice.
(4) A manufacturing corporation shall not fail to comply with a notice served on the manufacturing corporation under this section that is in force.
Penalty: $5,000.
THERAPEUTIC GOODS ACT 1966 - SECT. 23H.
InterpretationSECT
PART IIIB-NATIONAL REGISTER OF THERAPEUTIC GOODS
23H. A reference in this Part to goods for therapeutic use does not include a reference to goods that are not for human use.
THERAPEUTIC GOODS ACT 1966 - SECT. 23J.
Additional operation of PartSECT
23J. Without prejudice to its effect apart from this section, this Part also has, by force of this sub-section, the effect it would have if-
(a) any reference in section 23M to the production in Australia of goods for therapeutic use were, by express provision, confined to-
(i) the production in Australia of such goods for supply-
(A) in the course of trade or commerce among the States, between a State and a Territory or between two Territories;
(B) under a law of the Commonwealth relating to the provision of pharmaceutical benefits;
(C) to the Commonwealth or the Northern Territory or to an authority of the Commonwealth or of a Territory; or
(D) in an internal Territory; or
(ii) the production of such goods in an internal Territory; and
(b) any reference in that section to the supply in Australia of goods for therapeutic use were, by express provision, confined to-
(i) the supply in Australia of such goods-
(A) in the course of trade or commerce among the States, between a State and a Territory or between two Territories;
(B) under a law of the Commonwealth relating to the provision of pharmaceutical benefits; or
(C) to the Commonwealth or to the Northern Territory or to an authority of the Commonwealth or of an internal Territory; or
(ii) the supply of such goods in an internal Territory;
(c) any reference in that section to a prescribed corporation included a reference to a person not being a prescribed corporation.
THERAPEUTIC GOODS ACT 1966 - SECT. 23K.
Object of PartSECT
23K. The object of this Part is to provide for the establishment and maintenance, so far as the Constitution permits, of a record of such information relating to goods for therapeutic use that are supplied in Australia, or produced in Australia, as is necessary to be kept in the interest of the public health of the people of the Commonwealth.
THERAPEUTIC GOODS ACT 1966 - SECT. 23L.
National Register of Therapeutic GoodsSECT
23L. (1) There shall be a register, to be known as the National Register of Therapeutic Goods, in which shall be entered such information in relation to goods for therapeutic use that are supplied in Australia or produced in Australia as the Director-General determines.
(2) The National Register of Therapeutic Goods shall be maintained in accordance with directions given by the Director-General and may, if he so directs, be maintained in a computer.
THERAPEUTIC GOODS ACT 1966 - SECT. 23M.
Director-General may obtain informationSECT
23M. (1) For the purpose of compiling and maintaining the National Register of Therapeutic Goods, the Director-General may, by notice in writing served on a prescribed corporation that supplies in Australia, or produces in Australia, goods for therapeutic use, require that prescribed corporation to furnish, in writing, to the Director-General, or another person specified in the notice, within such period as is specified in the notice, such information in respect of goods for therapeutic use that the prescribed corporation has supplied in Australia, or has produced in Australia, as is required by the notice.
(2) A notice served on a prescribed corporation under sub-section (1) shall not require the prescribed corporation to furnish information in respect of goods for therapeutic use that consist of a substance unless-
(a) the goods are declared, or are included in a class of goods that are declared, by the regulations to be goods to which this section applies; and
(b) the information relates to prescribed matters.
(3) A notice served on a prescribed corporation under sub-section (1) may relate to-
(a) specified goods that have been supplied in Australia or produced in Australia by the prescribed corporation;
(b) all goods of a specified description that the prescribed corporation has, within a period specified in the notice, supplied in Australia or produced in Australia; or
(c) all goods for therapeutic use that the prescribed corporation has, within a period specified in the notice, supplied in Australia or produced in Australia.
(4) The Director-General may, where he considers it appropriate to do so, include in a notice under sub-section (1) a direction that a prescribed corporation shall, not less than 14 days before supplying in Australia any goods for therapeutic use to which the notice relates and in respect of any matter relating to which the information furnished in accordance with the notice is not correct, furnish to the Director-General in writing correct information in relation to those matters.
(5) Where a notice served on a prescribed corporation under sub-section (1) is in the form referred to in paragraph (3) (b) or (c), the Director-General may, if he considers it appropriate to do so, include in that notice a direction that, if at any time the prescribed corporation commences to supply in Australia, or to produce in Australia, goods of the description to which the notices relates, being goods that the prescribed corporation has not, within the period specified in the notice in accordance with paragraph (3) (b) or (c), as the case may be, so supplied or produced, the prescribed corporation shall not supply those goods in Australia to another person unless the prescribed corporation has, not less than 14 days before supplying those goods, furnished to the Director-General in writing the information required by the notice in respect of the goods.
(6) Where-
(a) a prescribed corporation has, in compliance with a notice under this section, furnished information in relation to goods; and
(b) the corporation ceases to supply in Australia, or to produce in Australia, such goods,
the corporation shall forthwith notify the Director-General in writing that it has so ceased to supply or to produce such goods, as the case requires.
(7) A person shall not fail to comply with a notice served on him under this section.
Penalty: $200.
(8) A person shall not, in purported compliance with a notice served on him under this section, knowingly furnish information that is false or misleading in a material particular.
Penalty: $2,000.
(9) A prescribed corporation is not excused from furnishing information in pursuance of a notice served on it under this section on the ground that the information might tend to incriminate it, but any information furnished in pursuance of the notice is not admissible in evidence against it in any criminal proceedings, other than proceedings under sub-section (8).
THERAPEUTIC GOODS ACT 1966 - SECT. 24.
Regulations may provide for the examination, &c., of goods for therapeutic
useSECT
PART IV-MISCELLANEOUS
24. (1) The regulations may make provision for or in relation to the examination, testing and analysing of goods to which this section applies.
(2) Without limiting the generality of sub-section (1), the regulations which may be made by virtue of that sub-section include regulations making provision-
(a) for or in relation to the taking of samples of goods to which this section applies;
(b) for or in relation to the authorization of persons to take, and to enter upon premises for the purposes of taking, samples of goods to which this section applies and to make examinations and inquiries with respect to matters relating to goods to which this section applies;
(c) for or in relation to the appointment or establishment of laboratories for the examination, testing and analysing of goods to which this section applies;
(d) for the issue of certificates by persons who have examined, tested or analysed goods to which this section applies; and
(e) for prescribing the extent to which certificates issued under the regulations are evidence of matters stated in the certificates.
(3) The goods to which this section applies are goods for therapeutic use that-
(a) are imported into Australia;
(b) are proposed to be exported from Australia;
(c) have been, are or are proposed to be, the subject of trade or commerce among the States;
(d) have been supplied as a pharmaceutical benefit under a law of the Commonwealth relating to the provision of pharmaceutical benefits or are in the possession of a person who is an approved pharmaceutical chemist under such a law at premises in respect of which he is so approved; or
(e) have been supplied to the Commonwealth or the Northern Territory or to an authority of the Commonwealth or of a Territory or are in the possession of a person who is a party to a subsisting contract for the supply of goods of that kind to the Commonwealth or the Northern Territory or to such an authority.
THERAPEUTIC GOODS ACT 1966 - SECT. 25.
Offences-GeneralSECT
25. (1) A person who contravenes, or fails to comply with, a provision of this Act is (unless section 41 of the Acts Interpretation Act 1901 in its application in relation to that provision otherwise provides that the person is guilty of an offence) guilty of an offence against this Act.
(2) Subject to sub-section 25A (1), an offence against this Act (other than an offence against sub-section 9 (2), 9 (2A), 23G (4), 23M (7), 23M (8) or 25B (1)) is an indictable offence.
(3) Subject to sub-section 25A (2), the punishment for an offence against this Act (other than an offence against sub-section 9 (2), 9 (2A), 23G (4), 23M (7), 23M (8) or 25B (1)) is punishable on conviction-
(a) if the offender is a natural person-by a fine not exceeding $10,000 or imprisonment for a period not exceeding 2 years, or both; or
(b) if the offender is a body corporate-by a fine not exceeding $50,000.
(4) In addition to any other punishment, a court may, if it thinks fit, order the forfeiture of goods in respect of which an offence against this Act has been committed.
THERAPEUTIC GOODS ACT 1966 - SECT. 25A.
Prosecution of offencesSECT
25A. (1) Notwithstanding that an offence referred to in sub-section 25 (2) is an indictable offence, a court of summary jurisdiction may hear and determine proceedings in respect of such an offence if the court is satisfied that it is proper to do so and the defendant and the prosecution consent.
(2) Where, in accordance with sub-section (1), a court of summary jurisdiction convicts a person of an indictable offence, the penalty that the court may impose is-
(a) if the offender is a natural person-a fine not exceeding $1,000 or imprisonment for a period not exceeding 6 months, or both; or
(b) if the offender is a body corporate-a fine not exceeding $5,000.
THERAPEUTIC GOODS ACT 1966 - SECT. 25B.
Continuing offencesSECT
25B. (1) Where-
(a) by or under a provision of this Act a person is required or directed to do an act or thing within a particular period;
(b) failure by that person to do that act or thing within that period constitutes an offence; and
(c) the person does not do that act or thing within that period,
the following provisions of this sub-section have effect:
(d) the obligation of the person to do that act or thing continues, notwithstanding that that period has expired, until that act or thing is done;
(e) the person is guilty of a separate and further offence in respect of each day after the expiration of that period during which the failure to do that act or thing continues; and
(f) the punishment for each such separate and further offence is a fine not exceeding $200.
(2) Charges against the same person for any number of offences under paragraph (1) (e) may be joined in the same information or complaint if those offences relate to a failure to do the same act or thing.
(3) If a person is convicted of more than one offence under paragraph (1) (e), the court may impose one fine in respect of all the offences of which the person is so convicted under that paragraph but that fine shall not exceed the sum of the maximum fines that could be imposed if a fine were imposed in respect of each offence separately.
THERAPEUTIC GOODS ACT 1966 - SECT. 26.
Judicial noticeSECT
26. All courts shall, for the purposes of proceedings arising under this Act, take judicial notice of the British Pharmacopoeia and of any publication referred to in paragraph 16A (1) (b).
THERAPEUTIC GOODS ACT 1966 - SECT. 26A.
Service of noticesSECT
26A. A notice under section 9, 23D, 23E, 23G or 23M may be served on a person-
(a) in the case of a natural person-by serving the notice or a copy of the notice personally on the person or by sending the notice or a copy of the notice by post to the person at his last known place of residence or business; or
(b) in the case of a body corporate-by sending the notice or a copy of the notice by post to the registered office (if any) of the body corporate or by serving the notice or a copy of the notice personally on the secretary or another executive officer of the body corporate or on a person who, at the time of service, apparently manages a place of business of the body corporate.
THERAPEUTIC GOODS ACT 1966 - SECT. 27.
DelegationSECT
27. (1) The Minister or the Director-General may, either generally or as otherwise provided by the instrument of delegation, by writing signed by him, delegate to a person any of his powers under this Act, other than this power of delegation.
(2) A power so delegated, when exercised by the delegate, shall, for the purposes of this Act, be deemed to have been exercised by the Minister or the Director-General, as the case may be.
(3) A delegation under this section does not prevent the exercise of a power by the Minister or the Director-General, as the case may be.
THERAPEUTIC GOODS ACT 1966 - SECT. 28.
Saving of other lawsSECT
28. This Act is not intended to exclude or limit the operation of any other law of the Commonwealth or of any law of a State or Territory.
THERAPEUTIC GOODS ACT 1966 - SECT. 29.
Dangerous substancesSECT
29. (1) Where the Governor-General is satisfied that a substance, or the use of a substance, is causing, or is likely to cause, the occurrence in Australia of a serious outbreak of disease in persons or animals or is endangering, or is likely to endanger, the life or health of persons or animals in Australia, the regulations-
(a) may prohibit the importation into Australia of goods consisting of the substance; and
(b) may declare that quarantine measures are necessary in relation to goods consisting of the substance.
(2) The Minister may, by instrument in writing and subject to such conditions, if any, as are specified in the instrument, exempt from regulations made by virtue of paragraph (1) (a) the importation by a person specified in the instrument of goods consisting of a substance so specified.
(3) Where a condition specified in an instrument of exemption issued under sub-section (2) is not complied with, the person in whose favour the exemption was granted shall be deemed to have committed an offence against this Act.
(4) Goods the importation of which is prohibited under regulations made by virtue of paragraph (1) (a) are prohibited imports for the purposes of the Customs Act 1901-1966, and the provisions of that Act relating to prohibited imports apply accordingly.
(5) Where regulations made by virtue of paragraph (1) (b) are in force in relation to a substance, the Minister may, by order in writing, direct the person or persons to whom the order applies-
(a) to destroy, or to refrain from selling or distributing, goods consisting of the substance that are in his or their possession; or
(b) not to prepare goods consisting of or containing the substance.
(6) An order under sub-section (5) may be expressed to apply to persons generally, to persons included in a class of persons specified in the order or to a person specified in the order.
(7) An order under sub-section (5) does not have effect-
(a) in the case of an order expressed to apply to a person specified in the order-until the order has been served on the person either personally or by sending it by post to, or by leaving it at, his last-known address; and
(b) in any other case-until a copy of the order has been published in the Gazette.
(8) A person to whom an order under sub-section (5) applies shall comply with the directions in the order.
THERAPEUTIC GOODS ACT 1966 - SECT. 29A.
Applications for reviewSECT
29A. (1) Applications may be made to the Administrative Appeals Tribunal for review of relevant decisions.
(2) Where a person is given notice in writing of a relevant decision, the notice shall include a statement to the effect that, subject to the Administrative Appeals Tribunal Act 1975, application may be made to the Administrative Appeals Tribunal for review of the relevant decision to which the notice relates by or on behalf of the person or persons whose interests are affected by the relevant decision.
(3) Any failure to comply with the requirements of sub-section (2) in relation to a relevant decision does not affect the validity of the relevant decision.
(4) In this section, "relevant decision" means-
(a) a refusal by the Director-General to grant an application made under paragraph 23D (2) (b);
(b) a revocation by the Director-General pursuant to sub-section 23D (5) of a notice under paragraph 23D (2) (b);
(c) a refusal by the Director-General to grant an application made under paragraph 23E (5) (a), (7) (a) or (7) (b);
(d) a refusal by the Director-General to grant an application made under sub-section 23E (8); and
(e) a revocation by the Director-General pursuant to sub-section 23E (9) of a notice under paragraph 23E (5) (a), (7) (a) or (7) (b).
THERAPEUTIC GOODS ACT 1966 - SECT. 30.
RegulationsSECT
30. The Governor-General may make regulations, not inconsistent with this Act, prescribing all matters which by this Act are required or permitted to be prescribed, or which are necessary or convenient to be prescribed for carrying out or giving effect to this Act, and in particular-
(a) for making provision for or in relation to-
(i) the establishment of committees to advise the Minister on matters relating to the importation into Australia of therapeutic substances and on such other matters as are prescribed, and the functions and powers of those committees; and
(ii) the payment of remuneration and allowances to members of committees established under the regulations; and
(b) for prescribing penalties for offences against the regulations not exceeding-
(i) in the case of offenders who are natural persons-a fine of $1,000 or imprisonment for 6 months; or
(ii) in the case of offenders that are bodies corporate-a fine of $2,000.
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