Traduction de «drug safety quality and efficacy » (Anglais → Français) :

30. Invites the Commission to facilitate the development of a core of technical and ethical standards for the management of the safety, quality and efficacy of organ donation in the context of donation and transplantation that can serve as a model for Member States; asks the Commission to establish an EU mechanism which would promote coordination activities between Member States in relation to organ donation and transplantation;

30. Invites the Commission to facilitate the development of a core of technical and ethical standards for the management of the safety, quality and efficacy of organ donation in the context of donation and transplantation that can serve as a model for Member States; asks the Commission to establish an EU mechanism which would promote coordination activities between Member States in relation to organ donation and transplantation;

The assessment of safety, quality and efficacy of medicines for children and the granting of marketing authorisations should remain the remit of the competent authorities.

Its use is unique and everyone expects a medicinal product to be safe and to work effectively. Safety, quality and efficacy are the three essential pillars of the European medicinal products market.

(7) With the exception of those medicinal products which are subject to the centralised 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), a marketing authorization in one Member State ought to be recognized by the competent authority 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; in the event of a disagreement between Member States about the qua ...[+++]lity, the safety or the efficacy of a medicinal product, a scientific evaluation of the matter should be undertaken at a Community level, lead to a single decision on the area of disagreement, binding on the Member States concerned.

With the exception of those medicinal products which are subject to the centralised 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 , a marketing authorization in one Member State ought to be recognized by the competent authority 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; in the event of a disagreement between Member States about the qua ...[+++]lity, the safety or the efficacy of a medicinal product, a scientific evaluation of the matter should be undertaken at a Community level, lead to a single decision on the area of disagreement, binding on the Member States concerned.