Amendments to the Therapeutic Goods Advertising Code (TGAC)

The Therapeutic Goods Advertising Code Council (TGACC) recently recommended that some amendments to the Therapeutic Goods Advertising Code (TGAC) be made.

A number 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. 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.

For further details on these changes, see page 13 <http://www.tga.gov.au/docs/html/tganews/news29/cab.htm>.

Australian Codes of GMP current status & future directions

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.

For further details on these changes, see page 13 <http://www.tga.gov.au/docs/html/tganews/news29/cab.htm>.

Roger Howard retirement

Roger Howard retired on 12 February 1999 after a distinguished public service career lasting 42 years. Roger joined NBSL, the forerunner of TGA Laboratories in 1961. He was head of the Antibiotics Section for many years and later headed the Chemistry Section (formed from a combination of the Antibiotics and Pharmaceutical Chemistry sections). Roger will be remembered for his outstanding contribution to the regulation of antibiotics in Australia and for his interest in public health, particularly through the Working Party on Antibiotics.

The Australian Radiation Protection and Nuclear Safety Agency (ARPANSA)

On 5 February 1999 the Executive Council proclaimed the Australian Radiation Protection and Nuclear Safety Act 1998 and this legislation took effect from that day. The object of the legislation is to protect the health and safety of the general public, and to protect the environment, from the harmful effects of radiation. The legislation establishes an office of the Chief Executive Officer of a new portfolio agency: the Australian Radiation Protection and Nuclear Safety Agency (ARPANSA).

The new Agency has been formed from the Australian Radiation Laboratory (ARL) and the Nuclear Safety Bureau (NSB) and will therefore continue to provide scientific services and advice in relation to radiation matters. The Agency will also administer the new legislation that requires Commonwealth agencies involved in radiation or nuclear activities to be licensed.

The new Agency will maintain two offices, one in Sydney and one in Melbourne.

SYDNEY PO Box 655 Miranda, NSW, 2228 Phone: 02 9524 1164 Fax: 02 9540 1808

MELBOURNE Lower Plenty Road Yallambie, Victoria, 3085 Phone: 03 9433 2211 Fax: 03 9432 1835

TICC meeting

This photo was taken at the last TGA-Industry Consultative Committee (TICC) meeting. The TICC is a consultative forum that provides an opportunity for industry and consumer representatives to comment on, and provide input to, the TGA's policy development and financial management.

The Parliamentary Secretary, Senator the Hon. Grant Tambling was invited to attend the meeting to meet with members.

Those present from left were David Johnston (CHC), Deborah Monk (APMA), Ngaire Bryan (TGA), Janice Hirshorn (APMA), Anne Bassett (MIAA), Terry Slater (TGA), Senator Tambling (Parliamentary Secretary) Juliet Seifert (PMAA), Derek Tye (PMAA), Janne Graham (consumer representative) and Bronwyn Capanna (PMAA).

Trans tasman harmonisation of scheduling of drugs and poisons

Following its establishment by the National Drugs and Poisons Schedule Committee (NDPSC), the Working Party on Trans-Tasman Harmonisation of Scheduling of Drugs and Poisons (WP) met twice in Wellington, New Zealand (NZ) during 1998, and in Canberra on 19 February 1999. The WP is to examine ways of achieving harmonisation in scheduling and related matters in respect of both technical and policy aspects; and to recommend to the NDPSC a process for the assessment of regulatory impact, consultation and time-frame of implementation of any proposed changes in scheduling. This work will extend the agreements reached with New Zealand in 1995, to phase in the harmonisation of labelling of drugs and poisons by 30 June 2000.