Commonwealth Numbered Regulations - Explanatory Statements

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THERAPEUTIC GOODS REGULATIONS (AMENDMENT) 1992 NO. 430

STATUTORY RULES 1992 No. 430

Issued by Authority of the Minister for Aged, Family and Health Services

Therapeutic Goods Act 1989

Therapeutic Goods Regulations (Amendment)

The Therapeutic Goods Act 1989 (the Act) has for its objective the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or exported from Australia.

Paragraphs 17(4)(c), 63(1)(b) and 63(2)(e) of the Act enable the Governor-General to make regulations prescribing, among other things, matters necessary or convenient to be prescribed for carrying out or giving effect to the Act, including prescribing requirements for informational material that is to be included with therapeutic goods and prescribing the ways in which goods that have been assigned a registration or listing number may be assigned a different registration or listing number.

Accordingly, the Regulations:

(a)       extend by a further year the period during which State and Territory laws identified in Regulation 3 of the Therapeutic Goods Regulations may continue to operate in conjunction with Commonwealth legislation dealing with therapeutic goods, until State and Territory legislation to mirror and complement the Act is enacted;

(b)       in line with Professor Baume's Recommendation 50 contained in his "Report on the Future of Drug Evaluation in Australia", adopted by the Government in July 1992 as a package, require Patient Information to be included with therapeutic goods supplied to patients where such goods are approved for marketing after 1 January 1993;

(c)       enable the Secretary to assign and change registration and listing numbers to cover situations where, under section 16 of the Act, goods are "grouped" together, or regrouped, or split up and a different number is required to identify goods belonging to different groups as well as goods that have moved from one group to another group;

(e)       enable appeals to be made to the Administrative Appeals Tribunal in respect of decisions made under new Regulation 14A of the Regulations, concerning what registration or listing numbers should be assigned to grouped or single therapeutic goods affected by the grouping orders made under section 16 of the Act.

Subregulation 1.1 defers the commencement of Regulations 4 and 7, dealing with Patient Information, until 1 January 1993, in line with Professor Baume's Recommendation 50.

Subregulation 3.1 enables the State and Territory legislation set out in Regulation 3 to continue to operate for a further year until 14 February 1994, when it is anticipated that State and Territory legislation to mirror and complement the Act may be enacted.

Subregulation. 4.1 inserts a new Part 2A into the Regulations, to require Patient Information to be supplied with certain drugs registered after 1 January 1993. These are drugs identified in Schedule 10 to the Regulations.

New subregulation 9A(1) creates an offence for therapeutic goods, described in Schedule 10 to the Regulations, to be supplied without Patient Information where such goods have been registered in the Australian Register of Therapeutic Goods (ARTG) on or after 1 January 1993. The patient information must contain information of a kind identified in proposed Schedule 12. The requirements set out in Schedule 12 were formulated by the Australian Pharmaceutical Manufacturers' Association, which represents the industry affected by proposed new Regulation 9A. A penalty of $1000 for individuals, or $5000 for corporations, applies for a breach of this provision.

New subregulation 9A(2) prescribes how the patient information is to be provided. The information should be provided in the packaging of the goods supplied to the consumer, or in such other form as would enable that information to be given to the patient or consumer in written form.

Subregulation 5.1 inserts new Regulations 14A, 14B and 14C into the Regulations.

New Regulation 14A prescribes how ARTG numbers may be assigned to therapeutic goods caught by the grouping orders made under section 16 of the Act. Under section 16 of the Act, certain therapeutic goods may be grouped, for the purposes of, among other things, enabling all goods belonging to the same group to be assigned the same ARTG number. However, where a section 16 order is amended, or new section 16 orders are made so as to affect therapeutic goods already included in the ARTG or previously grouped under a different grouping, provision must be made to reassign new or different ARTG numbers to ensure that the status of such newly grouped, re-grouped or ungrouped goods will be identifiable through the reassignment or assignment of appropriate ARTG numbers.

New Regulation 14A will enable sponsors to apply to have appropriate ARTG numbers assigned or reassigned where their goods are affected by grouping orders under section 16 of the Act, or will enable the Secretary to act on his or her own initiative to assign or reassign ARTG numbers to grouped, re-grouped or ungrouped therapeutic goods.

New Regulation 14B will enable the Secretary to amend a registration or listing number (ARTG number) for individual therapeutic goods or grouped therapeutic goods to correct a clerical error or mistake.

New Regulation 14C requires the Secretary to notify the relevant sponsor of any changes to the registration or listing number of that sponsor's goods effected as a consequence of action taken under proposed new Regulations 14A or 14B.

Subregulation 6.1 enables a sponsor to appeal to the Administrative Appeals Tribunal in respect of any action taken to assign or reassign ARTG numbers under proposed new subregulations 14A(3), (4), (5) or (6).

Subregulation 7.1 inserts a new Schedule 12, which incorporates in its entirety a document formulated by the Australian Pharmaceutical Manufacturers' Association, setting out the kind of information that should be included in Patient Information accompanying Schedule 10 Drugs, to assist patients and consumers using such medication.

The Regulations will commence on the day of Gazettal, except for Regulation 4 which is to commence on 1 January 1993, in line with Professor Baume's Recommendation 50.