Considerations on COM(2012)51 - Amendment of Regulation (EC) No 726/2004 as regards pharmacovigilance

Please note

This page contains a limited version of this dossier in the EU Monitor.

 
dossier COM(2012)51 - Amendment of Regulation (EC) No 726/2004 as regards pharmacovigilance.
document COM(2012)51 EN
date October 25, 2012
 
table>(1)In order to ensure transparency on the surveillance of authorised medicinal products, the list of medicinal products subject to additional monitoring established by Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (3), should systematically include medicinal products that are subject to certain post-authorisation safety conditions.
(2)In addition, voluntary action by the marketing authorisation holder should not lead to a situation where concerns relating to the risks or benefits of a medicinal product authorised in the Union are not properly addressed in all Member States. Therefore, the marketing authorisation holder should be obliged to inform the European Medicines Agency of the reasons for withdrawing or interrupting the placing on the market of a medicinal product, for requesting that a marketing authorisation be revoked, or for not renewing a marketing authorisation.

(3)Since the objective of this Regulation, namely to provide for specific rules on pharmacovigilance and improve the safety of medicinal products for human use authorised pursuant to Regulation (EC) No 726/2004, cannot be sufficiently achieved by the Member States and can therefore be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.

(4)Regulation (EC) No 726/2004 should therefore be amended accordingly,