Advertising therapeutic products

An Interim Advertising Council (IAC) has been established to consider and further develop the recommendations from the Review of Advertising Therapeutic Products in Australia and New Zealand <http://www.tga.gov.au/docs/html/advrev.htm> that was undertaken in 2002.

The IAC will report to the TGA and Medsafe in February 2004 with recommendations on the implementation of a trans-Tasman therapeutic products advertising scheme.

• See: Development of a trans Tasman advertising scheme for therapeutic goods <http://www.anztpa.org/advert/advtt.htm>

Human embryos/embryonic stem cells

On 12 May 2003, Senator Harradine wrote to Senator Kay Patterson, former Minister for Health and Ageing, notifying that he intended to move amendments to the Therapeutic Goods Amendment Bill (No.2) 2002. The proposed amendments were to ensure that information is available with pharmaceutical products so that consumers can determine whether the pharmaceuticals were tested, created or manufactured using human embryos or human embryonic stem cells.

The Minister undertook to review the issue and consult with industry, tabling a Report in the Senate.

• TGA report on information and advertising associated with products tested, created or manufactured using human embryos or human embryonic stem cells <http://www.tga.gov.au/advert/stemcells.htm>

Influenza vaccines

The Australian Influenza Vaccine Committee met on 16 October 2003 and agreed to adopt the October WHO recommendations for the composition of influenza vaccines for the 2004 season.

Product recalls

Seven consumer-level medicine recalls have occurred since the last issue of TGA News.

• Medicine & medical device recall notices <http://www.tga.gov.au/recalls/index.htm>

Tamper evident packaging

The Code of Practice for the Tamper-Evident Packaging (TEP) of Therapeutic Goods (Edition 1, June 2003) <http://www.tga.gov.au/docs/html/tepguide.htm> has been published by the TGA on behalf of the Industry Government Crisis Management Committee (IGCMC).

It is intended that the Code of Practice will become mandatory under therapeutic goods legislation on 1 January 2005, with a one-year transition period (starting 1 January 2004) during which sponsors will need to ensure full compliance.

TGC 22

The 22nd meeting of the Therapeutic Goods Committee was held on 11 August 2003.

• Therapeutic Goods Committee 22nd meeting, 11 August 2003, Summary of key resolutions <http://www.tga.gov.au/docs/html/tgc/tgc22.htm>

Therapeutic Goods Orders

Comments on the draft of TGO61A - Replacement of TGO 61 - Contraceptive Devices - Rubber Condoms closed on 31 October 2003. The order will take effect 6 months after gazettal.

TGO71 Tamper-Evident Packaging (TEP) of Therapeutic Goods will adopt the Code of Practice for the Tamper-Evident Packaging (TEP) of Therapeutic Goods (Edition 1, June 2003) <http://www.tga.gov.au/docs/html/tepguide.htm> as a standard for therapeutic goods in Australia. A draft of TGO 71 <http://www.tga.gov.au/docs/html/tepguide.htm> has been prepared in accordance with the recommendation of the Therapeutic Goods Committee that the Code of Practice be adopted as a standard made under section 10 of the Therapeutic Goods Act 1989, with effect from 1 January 2004.

The TGA proposes to revoke TGOs 9, 10, 12, 21, 25 and 30 on the basis that they are obsolete and/or no longer relevant to the TGA's area of regulation. Draft instruments revoking these TGOs have been prepared. See: Proposed revocation of Therapeutic Goods Orders 9, 10, 12, 21, 25 and 30