The Pharmaceutical Journal
Vol 272 No 7298 p560
8 May 2004

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News summary

New European medicines directives agreed

Three updated European directives — on human medicines (PDF 190K), veterinary medicines (PDF 200K) and traditional herbal medicines (PDF 100K) — have been finalised. In addition, an updated regulation on European rules for authorising medicines for use throughout the union has been published. And on 1 May, the European Medicines Evaluation Agency was renamed the European Medicines Agency (PDF 260K).

The new directive on human medicines requires European Union member states to change national legislation so that local practices do not hinder the free movement of medicines throughout the union. It also updates mutual recognition procedures so that they cannot be abused to slow down the introduction of new medicines. In particular, mutual recognition will no longer be available as an alternative route to medicines licensing through the centralised procedure.

The directive on traditional herbal medicines allows the licensing of herbal medicines on the basis of their historic use. The provision only applies to herbal medicines with a history of use within the European Union. Non-medicinal herbal products remain regulated by food legislation.

Member states have until 30 October 2005 to align national legislation with the directives.