Considerations on COM(2012)51 - Amendment of Regulation (EC) No 726/2004 as regards pharmacovigilance - Main contents
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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. |
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document | COM(2012)51 |
date | October 25, 2012 |
(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, |