Text tabled : A7-0153/2010

  Maria do Céu Patrão Neves (PPE), in writing. – (PT) I voted for this report as the topic it addresses – pharmacovigilance – is increasingly important in scientifically and technologically developed societies, particularly in relation to biomedical research. It strengthens the previous provisions of Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use, updating it to meet today’s needs.

In this respect, I would particularly highlight the importance of cooperation between Member States. Since it can result in a much larger pool of information on adverse drug reactions, it means that rarer patterns can be picked up more quickly. In other words, it makes pharmacovigilance more effective. A related point to be emphasised is the fact that the new system proposes that all adverse drug reactions be reported to the European Medicines Agency. The broadening of criteria and the centralisation of institutions will help biomedical research and provide valuable benefits to society.