European Medicines Agency publishes format for submission of information on medicines

The European Medicines Agency (EMA), on 1 July 2011, reached the first milestone in the implementation of the new pharmacovigilance legislation, by publishing the format in which pharmaceutical companies need to submit information on all of the medicines authorised or registered in the European Union. The Agency also published a legal notice summarising the main requirements of pharmaceutical companies, supported by a detailed guidance document.

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