Traduction de «Agence européenne pour l'évaluation des médicaments » (Français → Anglais) :

The European Medicines Evaluation Agency (EMEA) organised an expert meeting in November 2004, which stressed that no legislative provisions should be made before a wide-ranging consultation process with all the relevant stakeholders has taken place, and highlighted the importance of ensuring high quality and validation methods for pharmacogenetic tests.

These measures include a Commission Regulation on incentives for Small and Medium-sized Enterprises (SMEs) in their dealings with the European Medicines Agency (EMEA).

The European Medicines Evaluation Agency (EMEA) organised an expert meeting in November 2004, which stressed that no legislative provisions should be made before a wide-ranging consultation process with all the relevant stakeholders has taken place, and highlighted the importance of ensuring high quality and validation methods for pharmacogenetic tests.

In particular, some of the registration procedures used by the European Medicines Agency (EMEA) are both complex and expensive and may act as a major disincentive to the introduction of new products by SMEs.

Whereas, with the exception of those veterinary medicinal products which are subject to the centralized Community authorization procedure established by Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (5), an authorization to place a veterinary medicinal product on the market in one Member State ought in principle to be recognized by the competent authorities of the other Member States unless there are serious grounds ...[+++]for supposing that the authorization of the veterinary medicinal product concerned may present a risk to human or animal health, or to the environment; whereas, in the event of a disagreement between Member States about the quality, the safety or the efficacy of a veterinary medicinal product, a scientific evaluation of the matter should be undertaken by the Committee for Veterinary Medicinal Products attached to the European Agency for the Evaluation of Medicinal Products, lead to a single decision on the area of disagreement, binding on the Member States concerned; whereas this Decision should be adopted by a rapid procedure ensuring close cooperation between the Commission and the Member States;

Whereas, with the exception of those medicinal products which are subject to the centralized Community authorization procedure established by Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (7), an authorization to place a medicinal product on the market in one Member State ought in principle to be recognized by the competent authorities of the other Member States unless there are serious grounds for supposing that the ...[+++] authorization of the medicinal product concerned may present a risk to public health; whereas, in the event of a disagreement between Member States about the quality, the safety or the efficacy of a medicinal product, a scientific evaluation of the matter should be undertaken by the Committee for Proprietary Medicinal Products attached to the European Agency for the Evaluation of Medicinal Products, leading to a single decision on the area of disagreement binding on the Member States concerned; whereas this decision should be adopted by a rapid procedure ensuring close cooperation between the Commission and the Member States;