Regulatory Focus™ > News Articles > EMA Releases 'Practical Guidance' for Implementation of Pharmacovigilance Legislation

EMA Releases 'Practical Guidance' for Implementation of Pharmacovigilance Legislation

Posted 23 May 2012 | By Alexander Gaffney, RAC 

The European Medicines Agency (EMA) announced it has released what it is calling "practical guidance" in the form of a question and answer document seeking to answer some of the more common questions pertinent to pharmaceutical companies.

"The document, published today, clarifies some practical considerations that pharmaceutical companies will need to take into account before and after the legislation starts to apply in July this year," writes EMA. "It includes the agreed position of the European Union (EU) regulatory network, following discussions between the Agency, national regulatory authorities and the European Commission services."

The document, Questions and answers on practical transitional measures for the implementation of the pharmacovigilance legislation, breaks down the pharmacovigilance legislation into a number of easily-understandable topic areas.

These areas include good pharmacovigilance practices (GVPs), risk management plans (RMPs), post-authorization safety studies, pharmacovigilance system master files (PSMF), literature monitoring, periodic safety update reports (PSURs), product information and black symbols, adverse drug reactions (ADR) reporting, signal management and product renewals.


Read more:

EMA - Practical guidance on implementation of pharmacovigilance legislation published

Questions and answers on practical transitional measures for the implementation of the pharmacovigilance legislation


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