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Regulatory Focus™ > News Articles > EMA Releases Guideline on Pharmacovigilance Plan Submissions

EMA Releases Guideline on Pharmacovigilance Plan Submissions

Posted 01 March 2012 | By Alexander Gaffney, RAC 

The European Medicines Agency (EMA) released guidance 29 February on how Marketing Authorization Holders (MAH) can submit pharmacovigilance (PhV) systems as part of their Marketing Authorization Application.

The plans are used to detect, understand, prevent or otherwise minimize adverse events occurring as the result of medicinal products.

"This document provides clarification and further explanation of the requirements for a detailed description of the PhV system (DDPS)," writes EMA. "The DDPS is a document created for the purpose of assuring the EU Regulators that an effective system is in place at the time of an MAA, and will be checked during a PhV inspection."

Read more:

EMA - Pre-submission instruction on the detailed description of the pharmacovigilance system of a marketing authorisation holder; to be submitted with a marketing authorisation application for a veterinary medicinal product

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