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APVMA suspends veterinary products manufacturer's licence

Media release 03/ 5 29 April 2003

The national regulator of agricultural and veterinary chemicals, the Australian Pesticides and Veterinary Medicines Authority, today suspended for six months the licence of Pan Pharmaceuticals Limited to manufacture veterinary chemical products.

According to Mr Peter Raphael, Manager of the APVMA's Quality Assurance and Compliance Program, this decision was made because the APVMA can no longer be satisfied that the quality control practices followed by Pan Pharmaceuticals in the manufacture of its veterinary products are good enough to ensure their safety and efficacy.

This decision follows yesterday's announcement that the Therapeutic Goods Administration (TGA) was suspending Pan Pharmaceuticals' licence to manufacture human medicines because of safety and quality breaches in its manufacturing processes.

'Although the TGA's investigations focused only on the human medicines side of the manufacturing operations, the extent of the quality control problems identified was so great that they also undermined any confidence in Pan's veterinary product manufacture,' Mr Raphael said.

Pan Pharmaceuticals manufactures veterinary products for a number of other companies and does not market its own registered veterinary products.

'We are in the process of urgently identifying all those veterinary products for sale that contain ingredients manufactured by Pan Pharmaceuticals with a view to immediately recalling them from the marketplace,' Mr Raphael said. 'Pan Pharmaceuticals is only a minor manufacturer of veterinary products, so the impact of this decision on animal owners is likely to be small.'

'A list of the veterinary products to be recalled will be published on the APVMA website as soon as it has been completed. Advice for the general public who have purchased products affected by the recall will also be available on the website,' he said.