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Tag Archives: EMA Medicinal Products

PUBLIC CONSULTATION PROCESS LAUNCHED ON DRAFT REVISED GUIDELINE CONCERNING THE CONDITIONAL MARKETING AUTHORISATION PROCEDURE FOR MEDICINAL PRODUCTS

On 27 June 2015, the Committee for Medicinal Products for Human Use (“CHMP”) launched a two month public consultation process on a draft revised Guideline governing the implementation of Regulation (EC) No 507/2006 on the conditional marketing authorisation for medicinal products falling within the scope of Regulation (EC) No 726/2004.

EMA publishes a Questions & Answers document on the practical implementation of Article 31 Pharmacovigilance Referral procedure

On 20 January 2014, the European Medicines Agency (“EMA”) published a Questions & Answers document discussing the practical implementation of the “Article 31 Pharmacovigilance Referral” procedure. The aim of the document is to address questions that marketing authorisation holders may have in relation to this procedure and the manner in which it is handled by