Traduction de «évalué en fonction d'un usage humain » (Français → Anglais) :

6. The mandate of the Pharmacovigilance Risk Assessment Committee shall cover all aspects of the risk management of the use of medicinal products for human use including the detection, assessment, minimisation and communication relating to the risk of adverse reactions, having due regard to the therapeutic effect of the medicinal product for human use, the design and evaluation of post-authorisation safety studies and pharmacovigilance audit’.

The assessment procedures provided for in Directive 2001/83/EC should therefore apply for the single assessment of periodic safety update reports for different medicinal products for human use containing the same active substance or the same combination of active substances, including joint assessments of medicinal products for human use authorised both nationally and through the centralised procedure.

In order to ensure harmonised responses across the Union to safety concerns regarding medicinal products for human use, the Committee for Medicinal Products for Human Use and the coordination group established by Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (6) should rely on the recommendations of the Pharmacovigilance Risk Assessment Committee with regard to any question relating to the pharmacovigilance of medicinal products ...[+++]for human use.

However, for the sake of consistency and continuity of the safety assessments, the final responsibility for issuing an opinion on the risk-benefit assessment of medicinal products for human use authorised in accordance with Regulation (EC) No 726/2004 should remain with the Committee for Medicinal Products for Human Use and with the authorities competent for the granting of marketing authorisations.

—Changes subsequently introduced to the terms of a Plasma Master File must follow evaluation procedure laid down by Commission Regulation (EC) No 542/95 concerning the examination of variations to the terms of a marketing authorisation falling within the scope of Council regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products .

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 th ...[+++]e 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;