Rise in new medicines authorised

The number of investigations initiated for breaches of medicinal product legislation more than doubled from 1,397 in 2007 to …

The number of investigations initiated for breaches of medicinal product legislation more than doubled from 1,397 in 2007 to 3,037 the following, according to the Irish Medicines Board (IMB) annual report for 2008.

In 2008, the IMB seized a total of 299,053 tablets, 55,789 capsules, 24 litres of liquids and 36.5kg of creams. The active substances in these products covered a number of areas including zopiclone, corticosteroids, sildenafil citrate, prescription level vitamins, antibiotics and weight loss products.

The IMB attributed the rise in investigations to increased co-operation with the Customs and Excise section of the Revenue Commissioners over the illegal supply of medicines online.

It added that last year, 42,000 potentially harmful and illegal tablets were withdrawn from the Irish market following investigations.

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The annual report shows that the number of new medicines authorised by the IMB rose by 17 per cent form 1,082 to 1,268 over the year under review.

During 2008 the number of vigilance reports processed by the IMB’s Medical Devices Department rose 38 per cent to 1,160 and 240 new medical devices were registered.

In 2008, the IMB conducted 121 inspections at manufacturing sites including 23 foreign inspections and issued a total of 1,876 export certificates.

The organisation said it processed and evaluated 2,742 suspected adverse reactions associated with human medicines.

The board’s human medicines department processed 17,829 applications for medicines including new product authorisations, renewals and variations to product authorisations. Over the year, 1,268 new product applications were authorised.

In addition, the IMB’s veterinary medicines department received 1,371 applications for new medicines or changes to existing veterinary medicines.

Charlie Taylor

Charlie Taylor

Charlie Taylor is a former Irish Times business journalist