The EMA has published a Q and A document on transitional arrangements for the new pharmacovigilance legislation in preparation for July 2012.

The document addresses some of the questions that Marketing Authorisation Holders may have on areas such as the pharmacovigilance system master file, risk management plans and the submission of renewals.

The document can be found by following the link below:

http://ec.europa.eu/health/files/pharmacovigilance/2012_02_qa_phv.pdf