A Description and Appraisal of the New European Union (EU) Pharmacovigilance Legislation
Talbot JC.
RDD Europe 2015. Volume 1, 2015: 197-202.
Abstract:
New pharmacovigilance legislation, initially adopted in Directive 2010/84/EU [1] and Regulation (EU) No. 1235/2010 [2], started to come into effect in July 2012 and implementation continues into 2015. It aims to reduce the number of adverse drug reactions (ADRs) through collection of better data, rapid and robust assessment of safety issues, effective regulatory action, empowerment of patients and increased levels of transparency and better communication. It has significant implications and challenges for EU Marketing Authorization Holders (MAHs) and applicants for authorization to market. This presentation describes the new legislation and what it means for the pharmaceutical industry.
I have a subscription
Log in for instant access.
I do not have a subscription
Purchase Article (in PDF format)
