Today the Council, the European Parliament and the Commission agreed on a Directive and a Regulation that will strengthen the monitoring of medicine safety (pharmacovigilance).
Minister for Health, Astrid Krag, states:
"I am proud and content that we during the Danish Presidency have succeeded in agreeing on new rules that will strengthen the monitoring of medicine in the EU. The European citizens must rest assured that medicine marketed in the EU is safe. These new rules will contribute to ensuring this."
As a result of the new rules pharmaceutical companies will be obliged to let the authorities know the reasons behind a decision to stop the marketing of a product in order to prevent that serious safety concerns are kept secret hidden by a voluntary decision to withdraw a product from the market. The monitoring is also strengthened in other ways: an urgent union procedure will be initiated in case of serious safety concerns with regard to a medicinal product, and more medicinal products will automatically be put on a special monitoring list which is made publically available.
The Commission put forward its proposals for a Directive and a Regulation in October 2011 and February 2012. The proposals have been negotiated between the EU Member States in the Council and in the European Parliament. The political agreement is subject to final approval by the European Parliament, the Commission and the Council.
Special adviser Henrik Larsen, Ministry of Health, mobile + 45 50 84 48 66
Head of Division Katrine Schjønning, Ministry of Health, mobile + 45 25 27 56 32