Amendments to the Therapeutic Goods Advertising Code (TGAC)

The Therapeutic goods Advertising Code Council (TGACC) recently recommended to the Hon. Senator Grant Tambling, Parliamentary Secretary to the Minister for Health and Aged Care, that some amendments to the Therapeutic Goods Advertising Code (TGAC) be made. Anumber of amendments were proposed for the definitions in Clause 2 of the TGAC to more accurately reflect those contained in the Therapeutic Goods Act 1989 and Therapeutic Goods Regulations No.4. In addition, amendments were proposed for a number of prohibitions listed in Clause 4. These include references to baldness (to permit some claims for minoxidil S3 preparations), herpes virus infections (to allow some claims for typical cold sore type creams), and cellulite (claims in relation to reduction of subcutaneous fat 'cellulite' are not permitted). Amendments were also recommended for Clauses 7.4 ('stimulant' claims) and 9 (Testimonials). All of the TGACC's recommendations were accepted and the amendments became effective on 3 February 1999.

The majority of the new TGAC amendments are of a deregulatory nature, the effect of which is to provide sponsors with a wider scope of advertising claims which may be included in advertisements to the public for nonprescription products.

Australian codes of GMP current status & future directions

Current Status:

On 1 January 1999, the following changes to the Manufacturing Principles of the Therapeutic Goods Act 1989 took effect:

• Part 2 of the Australian Code of GMP for Medicinal Products was replaced with Annex 1 of the EU Guide to GMP.
• Appendices A, D, E & F to the Australian Code of GMP for Medicinal Products were revoked.
• European standards EN 46001-1996 and EN 46002-1996, Quality System requirements for medical devices, were adopted as Manufacturing Principles (replacing EN 46001-1993 and EN 46002-1993 respectively).
• European standard EN556, specifying a sterility assurance level for sterile medical devices, was adopted as a Manufacturing Principle.

From 1 January 1999, the following GMP documents available from TGA are current as Manufacturing Principles under the Therapeutic Goods Act 1989:

• Australian Code of GMP for Therapeutic Goods - Medicinal Products (incorporating Annex 1 of the EU GMP Guide)
• Australian Code of GMP for Therapeutic Goods - Blood and Blood Components
• Australian Code of GMP for Therapeutic Goods - Human Tissue
• Australian Code of GMP for Therapeutic Goods - Medicinal Gases
• Australian Code of GMP for Therapeutic Goods - Sunscreen Products
• Appendix G - Guidelines for Good Manufacturing Practice for Investigational Medicinal Products

Notes:

1. The Australian Code of Good Wholesaling Practice, although not a Manufacturing Principle, is available for purchase from TGA. This Code is for use by State Health authorities in the regulation of wholesalers under respective state legislation.
2. The Code of GMP for Medicinal Products is in the process of being revised to reflect the inclusion of Annex 1 of the EU GMP Guide.
3. A 12-month transition period will be applied to the adoption of Annex 1 of the EU GMP Guide into the Australian Code of GMP for Medicinal Products. That is, during 1999 Australian manufacturers of sterile medicinal products will have the option of using Annex 1 or the old Part 2 of the Australian Code.
4. The Manufacturing Principles applicable to medical devices are the European standards EN 46001* or EN 46002**, or the international standards ISO 13485* or ISO 13488**. These standards are not available from TGA but may be purchased from Standards Australia.

*applicable to registered medical devices unless exempted under schedule 7 of the regulations

**applicable to registered or listed medical devices unless exempted under schedule 7 of the regulations

Likely future directions:

• The possibility of using TGA's web site to publish Australian Codes of GMP in the future will be investigated.
• It is expected that an international GMP on APIs (active pharmaceutical ingredients) will be adopted as a Manufacturing Principle towards the end of 1999 or early in 2000.
• In a move to harmonise with Europe, it is expected that the Code of GMP for Medicinal Products will be replaced by the entire EU GMP Guide within 3 years.

Label verification for low risk medicinal products

At a recent meeting of the PIC/S (Pharmaceutical Inspection Cooperation Scheme) Committee of Officials it was decided that label verification need not be mandatory for low risk medicinal products provided other relevant label and packaging controls are observed by the manufacturer. PIC/S membership includes most countries of the European Union, as well as Canada and Australia.

In the interests of harmonising with PIC/S, TGA will adopt the following approach to label verification for GMP audits of local and overseas manufacturers of medicinal products supplied in Australia:

"Verification of labels and other printed packaging materials used for low risk medicinal products*, although good practice in helping to prevent label mix-ups, is not mandatory. Where label verification is not undertaken for these products, other relevant label control procedures should be in place, eg. approval of suppliers, QC checking of incoming labelling, secure storage, code number (unique to each amendment) shown on label text, formal line clearance checks, etc".

*medicinal products Listed on the ARTG, such as herbal, vitamin, homoeopathic, essential oil and sunscreen products, would be regarded as low risk medicinal products for the purpose of exception from label verification.

Medical devices page on the TGA website

The Therapeutic Goods Administration now has a Medical Devices <http://www.tga.gov.au/devices/devices.htm> page on its website.

The Medical Devices Page provides general information on the regulation and supply of medical devices in Australia. Guidelines on how to apply for registration or listing of a medical device and information on problem reporting of medical devices is also available at the site. In addition, the site also has links to:

• Australian Medical Devices Requirements under the Therapeutic Goods Act 1989 (version 4) "DR4";
• the Australian Therapeutic Device Bulletin;
• background and information on the proposed new Australian regulatory requirements for medical devices;
• the Australia - EC Mutual Recognition Agreement - Frequently Asked Questions;
• a paper on the proposed changes to the regulation of disinfectants, sterilising/disinfecting equipment and integrated systems.

For further information on the website please contact the TGA Publications Office on 1800 020 653.

Seminars on the Australia European Community Mutual Recognition Agreement (MRA) on conformity assessment

The Department of Industry, Science and Resources is hosting one day seminars on new opportunities for Australian manufacturers exporting to Europe, in Sydney on 8 June 1999 and in Melbourne on 10 June 1999. The seminars will provide information on the new approach to obtaining CE Marking Certification, (Australia European Community Mutual Recognition Agreement (MRA) on Conformity Assessment).

Participants in the seminars will learn about:

• Marketing Opportunities in the European Union
• Meeting European product requirements via the New Approach Directives
• The MRA - how it effects you if you are exporting or considering exporting to Europe
• Practical Steps to CE marking in Australia

Representatives from the Conformity Assessment Bodies (including TGA) who can assess your product to meet European regulatory requirements in Australia will be available to answer your questions.

Seminar participants will receive practical support material on requirements for marketing their products in Europe. Cost for the seminar will be $195.