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EMA publishes drug information format

The European Medicines Agency has published the format in which pharmaceutical companies are to submit information on all medicines registered in the European Union

The European Medicines Agency (EMA) has published the format in which pharmaceutical companies are to submit information on all medicines registered in the European Union (EU).

The latest requirement is part of the agency's pharmacovigilance plans to strengthen systems to monitor the safety of medicines in the EU, and increases transparency and access to information.

Companies will need to submit relevant information outlined in the guidance by July 2, 2012.

The EMA has said the data will enable the creation of a list of all medicines authorised and registered in the EU, both by the EMA and national regulatory bodies.

The plans will also improve the identification of medicines and better co-ordinate their regulation and monitoring, according to the EMA.

Beginning in autumn, companies can organise online and face-to-face sessions with the agency to discuss the requirements. The EMA has also designed a data-entry tool to help small and medium-sized businesses.

The EMA has further information on the new format for information on medicines.

4th July 2011

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