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Questions and Answers to support the implementation of the ...

30 November 2012. EMA/228816/2012 Patient Health Protection November 2015: This Q&A was developed in 2012 to provide practical guidance concerning the initial phases of operation of the pharmacovigilance legislation and will not be further updated. Please note that some Questions are no longer relevant or, otherwise, have been integrated in the EMA post-authorisation guidance. Questions and Answers to support the implementation of the Pharmacovigilance legislation - UPDATE, NOVEMBER. 2012. Introduction 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. Any specificities depending on the route of authorisation ( centralised procedure versus mutual recognition/decentralised procedure and purely national procedure) are highlighted when appropriate.

a transition period for the implementation of the new requirements and/ or where the GVP modules are not yet available. Volume 9A remains the reference as applicable until the transition period ends or

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