Commission Implementing Regulation on pharmacovigilance activities

Following its adoption on 19 June the Commission Implementing Regulation (EU) 520/2012 on the performance of pharmacovigilance activities has been published in the Official Journal of the European Union. This Implementing Regulation complements the 2010 pharmacovigilance legislation, which starts to apply in July 2012, by providing the more technical details that have to be observed by marketing authorisation holders, national competent authorities and EMA in the daily practice of applying the new legislation. It is therefore an important piece in the new framework, which will promote and protect public health by strengthening the European system for monitoring the safety and use of medicines.

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