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Pharmacovigilance / «Companies»

Single, central platform now mandatory for all periodic safety update reports

PSUR repository facilitates information exchange on the safety of human medicines authorised in the EU

As of 13 June 2016, all periodic safety update reports (PSURs) for human medicines authorised in the European Union (EU) must be submitted to the PSUR repository, which has been developed by the European Medicines Agency (EMA) in close collaboration with EU Member States and the industry.

More information on this is included in the hyperlink below:

Single, central platform now mandatory for all periodic safety update reports (10/06/2016)

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