The European Commission has published a Q&A document on transitional arrangements for the new pharmacovigilance legislation in preparation for the coming into force of the legislation in July 2012. Of particular interest to marketing-authorisation applicants and holders, the document provides answers to both legal and practical [...]
The European Medicines Agency (EMA) has published a new implementation plan detailing the activities around the new pharmacovigilance legislation scheduled for implementation in 2012 and those activities which will be the focus beyond 2012. Activities contributing to public health are given the highest priority, followed by activities to increase transparency and improve communication, and then [...]
The European Commission has published a summary of the responses to the public consultation on a concept paper concerning the Implementing Measures. The public consultation is part of the ongoing preparation of the Implementing Measures. The information and views gathered in this way will [...]
On Wednesday 30 November 2011 the Medicines Evaluation Board (MEB) organised an informative meeting in Utrecht about the implications of the new pharmacovigilance legislation. This meeting was primarily targeted at marketing authorisation holders.
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