Traduction de «Comité consultatif de la législation et des médicaments » (Français → Anglais) :

The Advisory Committee agrees with the Commission that the generic undertakings should be given a 10 % reduction in view of the long duration of the investigation.

The proposals simplify periodic safety update report submission by industry and make it proportional to the knowledge about the safety/risk of the product, would introduce work-sharing mechanisms for the assessments, with a prominent role in all cases by the Pharmacovigilance Risk Assessment Advisory Committee, and faster updating of product information through the establishment of clear procedures.

The Community procedure for the assessment of serious safety issues for nationally authorised products is stream-lined through clear and binding initiation criteria for the Member States, rules to ensure that all products concerned are considered, an assessment procedure by the Pharmacovigilance Risk Assessment Advisory Committee, and rules for the subsequent follow-up as regards the terms of the marketing authorisations with a view to the adoption of harmonised measures across the Community.

expressed satisfaction at the continued good functioning of the Agreement and underlined the importance of the participation of the EEA/EFTA States in the development and realisation of the internal market; noted the fact that the EEA Joint Committee had since the last meeting of the EEA Council adopted over 40 decisions incorporating some 70 pieces of Community legislation into the Agreement, including acts related to technical regulations for the telecommunications sector, to safety measures in rail, road, and sea transport and civil aviation; to foodstuffs and veterinary medicine legislation; to the environment; to mutual recogni ...[+++]tion of diplomas and access to certain professions, to competition rules and to intellectual property; EEA/EFTA States participation on the SAVE II and Info 2000 programs was also decided; procedures concerning EEA/EFTA States participation on Community programmes concerning small and medium sized enterprises and information society are now at its final stage; noted that the Joint Committee would, nevertheless, need to accelerate adoption of decisions to maintain full homogeneity of the EEA; noted, furthermore, that significant progress had been achieved on the important matter of veterinary legislation on which a Joint Committee decision was expected in time for the new system to be applied as of 1 January 1998 leading to facilitation of trade procedures and enhanced co-operation in the field of animal health; welcomed the substantive progress made on the incorporation of legislation on medicinal products and on preparations for the participation of the EEA/EFTA States in the European Agency for the Evaluation of Medicinal Products (EMEA); noted that the decision shaping provisions of the Agreement are being used increasingly, to the mutual benefit of both sides, in providing a solid basis of consultation of all Internal market partners for the preparation of relevant legislation; noted with satisfaction that progress ha ...

The delegation of the EFTA States participating in the EEA was headed by Mr ASGRIMSSON, Minister for Foreign Affairs of Iceland. 2. The EEA Council noted the progress report presented by the Chairman of the EEA Joint Committee. 3. The EEA Council assessed the overall functioning and development to date of the EEA Agreement and: - noted the continued progress of the Joint Committee in incorporating relevant Community legislation into the EEA Agreement and the need for continued support of its work if the objective of complete alignment of EEA and Community legislation were to be fully achieved; - recognized the crucial role of uniform ...[+++]implementation of legislation for the success of the internal market extended to the EEA and welcomed the good progress in integrating EEA legislation in Liechtenstein following its full participation from 1 May 1995; - noted that the provisions of the Agreement for development of cooperation had led to inclusion of new areas in the fields of both programmes and legislation; with regard to committees managing programmes in which the EFTA/EEA countries participate under Articles 81 and 82 of the Agreement, the EEA Council underlined the need to ensure the participation of the EFTA/EEA countries as soon as EFTA commitment has been assured; - welcomed the continuing participation of the EFTA States, through the consultation and information procedures, in the shaping of EEA-relevant legislation in preparation in the EU and noted the EFTA/EEA States' interest in participating in certain committees of similar characteristics to those listed in Protocol 37; - welcomed the resumption of formal meetings of the EEA Consultative Committee and the continued close contacts and cooperation at informal level; - noted the continuing difference of view between the EU and its EFTA partners on the EU's use of Articles 112 and 113 of the EEA Agreement in relation to fish.

Products are listed on the Ontario drug benefit formulary based on recommendations from the Canadian Expert Drug Advisory Committee, part of the common drug review; and the Committee to Evaluate Drugs, Ontario's expert advisory committee.