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EMA: Questions and answers on practical transitional measures for the implementation of the pharmacovigilance legislation

09.08.2012
This Question and Answer (Q&A) document provides practical considerations concerning the initial phases of operation of the new pharmacovigilance legislation (Regulation (EU) No 1235/2010 and Directive 2010/84/EU). The Q&A applies to all medicinal products for human use regardless of the route of authorisation.

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