Publication of questions and answers document clarifying procedural elements in relation to the implementation of new EU pharmacovigilance legislation

24 May 2012

This document clarifies, in a question and answer format, some practical considerations that pharmaceutical companies will need to take into account before and after the legislation starts to apply in July this year.

The document applies to all medicinal products for human use regardless of the route of authorisation.

The information provided represents the view of the European Medicines Agency and Member States and has been subject to consultation with the European Commission. It is recommended that the document is read in conjunction with Commission questions and answers on transitional arrangements (see European Commission website).

For further information concerning the new legislation, visit the relevant section of our website.