Commonwealth Numbered Regulations - Explanatory Statements

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THERAPEUTIC GOODS AMENDMENT REGULATIONS 2004 (NO. 2) 2004 NO. 127

The object of the Therapeutic Goods Act 1989 (the Act) is to establish and maintain a system of controls for the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or exported from Australia. The Therapeutic Goods Administration (the TGA) is responsible for administering the Act.

Subsection 63(1) of the Act provides that the Governor-General may make regulations, not inconsistent with the Act, prescribing matters required or permitted to be prescribed by the Act, or necessary or convenient to be prescribed for carrying out or giving effect to the Act. Paragraph 63(4)(b) of the Act provides that the regulations may make provision for a matter by applying, adopting or incorporating, with or without modification, any matter contained in an instrument, as that instrument is in force from time to time.

The purpose of the Regulations is to consolidate the warning statements required on certain labels applicable to therapeutic goods as advisory statements in a new document entitled Required Advisory Statements for Medicine Labels (RASML). The Regulations remove references to such warning statements from the Therapeutic Goods Regulations 1990 (the Principal Regulations) and replace them with references to the RASML.

Currently the Principal Regulations and various other ancillary documents, including Therapeutic Goods Order 69 General Requirements for labels for medicines, require warning statements to be included on the labels of certain medicines.

The RASML consolidates required advisory statements on labels for medicines into a single document. The RASML comes into effect on 1 July 2004 and will be published on the TGA website and notified in the Gazette. The requirements of the RASML generally apply to applications for new products from 1 July 2004. For existing products, the Principal Regulations continue to apply for a period of 12 months after commencement of the Regulations. Any subsequent changes to the RASML would be published in the Gazette.

Consolidating the required statements into a single document will improve consistency and transparency, reduce complexity of labelling requirements, and assist sponsors in complying with these requirements.

This transfer of medicine label warning statements to a single document implements certain recommendations of the National Competition Review of Drugs, Poisons and Controlled Substances Legislation (the Galbally Review) made in January 2001, including that:

•       the TGA be enabled to make decisions about labelling and packaging of medicines during their evaluation (recommendation 7);

•       labelling should be outcomes focused and simplified (recommendation 19); and

•       the TGA review the labelling requirements for medicines with a view to making labels more effective and reducing the complexity of labelling requirements (recommendation 19).

The changes do not have any regulatory impact on industry or other stakeholders and are considered mechanical in nature.

The Act specifies no conditions that need to be met before the power to make the Regulations may be exercised.

Details of the Regulations are set out in the Attachment.

The Regulations commence on 1 July 2004.

ATTACHMENT

DETAILS OF THE THERAPEUTIC GOODS AMENDMENT REGULATIONS 2004 (NO. 2).

Regulation 1 names the Regulations as the Therapeutic Goods Amendment Regulations 2004 (No. 2).

Regulation 2 provides that the Regulations commence on 1 July 2004.

Regulation 3 provides that Schedule 1 amends the Therapeutic Goods Regulations 1990 (the Principal Regulations).

Regulation 4 provides a transition period of 12 months from the date of commencement of the Regulations for goods that are registered or listed goods immediately before the commencement date. The effect is that registered or listed goods continue to be required to include the warning statements prescribed in the Principal Regulations for a period of 12 months from 1 July 2004.

SCHEDULE 1 - Amendments to the Principal Regulations

Item 1

Item 1 inserts a definition of Required Advisory Statements for Medicine Labels to mean the document of that name, published by the Therapeutic Goods Administration on 1 July 2004, as in force from time to time.

Item 2

Item 2 inserts a reference to the Required Advisory Statements for Medicine Labels (RASML) in subregulation 11(2).

Subregulation 11(2) provides the definition of restricted ingredients for the purposes of subregulation 11(1). Subregulation 11(1) provides the list of characteristics that separate and distinguish certain medicines from other therapeutic goods. The effect of the amendment is that subregulation 11(2) now provides that for an ingredient in a relevant medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance must also meet the requirements under the RASML.

Item 3

Item 3 removes the reference to a label showing a warning statement as being required by the Principal Regulations and substitutes this with the reference to the RASML. The warning statements will now be in this document and not in Division 3 of Part 5 of the Principal Regulations.

Items 4 - 9

These items remove the existing warning statements from Schedule 4, Part 4, Division 2 and substitute the required warning statement with "the label on the goods complies with the requirements of the Required Advisory Statements for Medicine Labels." The affected entries are Items 5A, 6, 20, 21, 32 and 35. Consistent with the purpose of the Regulations, the warning statements will now be included in the RASML.

Item 10

Item 10 substitutes a new Table in Schedule 4, Part 5, Division 3, which lists the substances requiring a label with an advisory statement. The new table removes the current warning labels for certain complementary medicines as listed in the Principal Regulations, and which will now be included in the RASML.