The European Commission has published 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 questions on a range of topics including renewal of applications, pharmacovigilance system master files and risk management plans.
New pharmacovigilance legislation (Regulation (EU) No 1235/2010 and Directive 2010/84/EU) was adopted by the European Parliament and European Council in December 2010. The European Medicines Agency is responsible for implementing much of the new legislation and is developing a framework for compliance and delivery of key requirements.
Any questions on the transitional arrangements should be sent to sanco-pharmaceuticals-d5@ec.europa.eu.