The Permanent Representatives Committee today approved a compromise agreed with the European Parliament on a draft regulation aimed at ensuring the funding of strengthened post-authorisation monitoring of medicines for human use ("pharmacovigilance") conducted at EU level. It herewith endorsed a compromise reached between the Greek presidency and representatives of the European Parliament and of the Commission on 12 February.

The EU rules on pharmacovigilance have been reinforced in 2010 and, following the Mediator case , in 2012. The agreement endorsed today is expected to provide the means to finance the work of addressing the safety concerns and maintain high standards of quality, safety and efficacy of medicinal products. "The agreement today is a great step towards the enhancement of public health, it secures the sustainability of the system while it is based on the principles of fairness and transparency", said the President of the Council, Greek Minister for Health, Adonis Georgiadis. In order to enter into force the draft regulation still needs to be formally approved by the European Parliament at plenary and by the Council once the text has been revised by the lawyer-linguists.

For more information about this draft regulation, visit the website of the Council of the EU.