Trans Tasman Harmonisation April 2002
Provided by Robert Forbes & Associates Pty Ltd, Sydney, Australia

Trans Tasman Harmonisation has created much discussion and also at times confusion. In response to requests from clients we have tried to clarify a number of concerns that regularly arise on Trans Tasman Harmonisation – see full story for details. Please feel free to contact Robert Forbes if you wish to discuss any of these items in further detail.

TGA News 

Medical Devices Bill passed by Parliament

The Therapeutic Goods Amendment (Medical Devices) Bill 2002 and the Therapeutic Goods (Charges) Amendment Bill 2002 were passed by Parliament on Thursday 21 March 2002. Implementation of the new regulatory framework for medical devices will be end of September 2002. Industry seminars to be held May/June on the new system – check website below for details.
http://www.health.gov.au/tga/docs/html/devbill.htm

Trans-Tasman Harmonisation

Further to information presented in Issue 11 newsletter, we advise that a formal discussion paper is due to be released by the Joint Agency in early May. In August both Governments will consider the best way to establish the agency and regulatory regime that it will administer. The precise regulatory controls will be settled after considering submissions made on the May discussion paper http://www.jtaproject.com

New Code of GMP for Australia

The TGC Subcommittee met on 25th February to decide the most appropriate Code to replace the Australian Code of GMP. The two codes considered were PIC/S Guide to GMP and EC Guide to GMP. The recommendation will be tabled at the April TGC meeting.

Overseas GMP Preclearance Assessment Checklist

The TGA has released a new checklist to help streamline the preclearance assessment of overseas manufacturers.

http://www.health.gov.au/tga/docs/pdf/oscheck.pdf

Standards for Ethanol

The TGC has recommended the revocation of TGO 29 Standards for Ethanol. This would result in the current edition of the British Pharmacopoeia (BP 2001) becoming the standard for Ethanol.

Child Resistant Packaging TGO

The TGC is working towards a new Therapeutic Goods Order (TGO) to specify standards for child-resistant packaging used for therapeutic goods. A revised draft TGO will be considered at the April TGC meeting.

TGA Publications

A revised list of new and updated publications can be found at http://www.health.gov.au/tga/pubs/pubs.htm

Practitioner Only Listed Medicines

Practitioner only goods must be Listed or Registered on the Australian Register of Therapeutic Goods (ARTG). Listed products supplied only to practitioners must comply with all the same standards and requirements that apply to all Listed medicines. The only special provision for 'practitioner only’ goods relate to some labelling requirements. Claims made to practitioners for a product must be as per the claims submitted to the TGA for inclusion on the ARTG.

¨      EU Guidelines published as Adopted in Australia

Since October 2001, over 70 new and replacement European Guidelines have been adopted in Australia. For details see

http://www.health.gov.au/tga/docs/html/euguideh.htm

Recalls

On 3rd April 2002, the following product was issued a Class II Recall:

¨      Twin Lab Metabolic Enhancer – Ripped Fuel – Mah Yuang (Mahuang) Free Formula (Australian Sponsor – Green Valley Nutrition Pty Ltd)

The product was supplied without being included on the Australian Register of Therapeutic Goods. The product also contains Yohimbine, a substance not approved for supply in Australia (Class II defects “could cause illness or mistreatment, but are not Class I”. Class I defects “are potentially life-threatening or could cause a serious risk to health”). http://www.health.gov.au/tga/docs/html/yuangrec.htm