The Pharmaceutical Journal
Vol 277 No 7410 p96
22 July 2006

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Dutch drug company wants damages from the MHRA

Synthon BV, a Dutch pharmaceutical company, is seeking damages from the UK medicines licensing authority, for refusing to license a paroxetine-based product under the European mutual recognition system.

Although a marketing authorisation was finally granted in February this year, Synthon is expected to press ahead with the case and wants a formal declaration that the initial refusal breached the European mutual recognition procedure. Synthon alleges that the Medicines and Healthcare products Regulatory Agency is operating an unlawful, inflexible policy that different salts of the same active principle can never satisfy the mutual recognition criterion of essential similarity.

The MHRA is contesting the claim, which has been referred to the European Court of Justice for adjudication.