Thomas-Mauro (NI), in writing. – (FR) It is a fact, the policy on medical products is now defined at European level. This development must be supported without jeopardising the operation of the national health systems and whilst respecting the need for maximum safety.

With regard to medicinal products for human use, Amendment No 71, which I tabled, fully supports this approach. It aims to learn lessons from the tragic ‘Bayer affair’ at the very time when the problems posed by the molecule cerivastatin have been raised once again in the United States.

We must reflect on the need to standardise the procedures that apply to clinical and pre-clinical trials. If the traceability of the marketing procedure were better assured, the safety of European patients would become more reliable.

A credible application of the centralised procedure for marketing medicinal products cannot work without this sort of approach.

I am opposed, however, to the full withdrawal of the decentralised procedure to the exclusive benefit of the centralised marketing procedure. The choice between these two systems must be maintained so that the European Agency does not remove the prerogatives of our national agencies.