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.
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.
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.