Translation of "high-technology medicinal product " (English → French) :

(iii) or that the medicinal product is essentially similar to a medicinal product which has been authorized within the Community, in accordance with Community provisions in force, for not less than six years and is marketed in the Member State for which the application is made. This period shall be extended to 10 years in the case of high-technology medicinal products having been authorised according to the procedure laid down in Article 2(5) of Council Directive 87/22/EEC(21). Furthermore, a Member State may also extend this period to 10 years by a single Decision covering all the medicinal products marketed on its territory where it co ...[+++]nsiders this necessary in the interest of public health.

(iii) or that the veterinary medicinal product is essentially similar to a medicinal product which has been authorized within the Community, in accordance with Community provisions in force, for not less than six years and is marketed in the Member State for which the application is made; this period shall be extended to 10 years in the case of high-technology medicinal products having been authorized in pursuance of the procedure established by Article 2(5) of Council Directive 87/22/EEC(13).

This involves in particular: - amendments to Directives 65/65/EEC, 75/318/EEC and 75/319/EEC on the approximation of the provisions laid down by law, regulation and administrative action relating to medicinal products for human use; - amendments to Directives 81/851/EEC and 81/852/EEC on the approximation of the laws of the Member States in respect of veterinary medicinal products; - the repeal of Directive 87/22/EEC on the approximation of national measures relating to the placing on the market of high technology medicinal products, particularly those der ...[+++]ived from biotechnology; The Council adopted the common positions on these three Directives at its meeting on 17 December 1992.

Since the adoption in December 1986 of four Directives aimed at promoting high technology medicinal products, particularly those derived from biotechnology, Europe has continued to stride forward in the pharmaceuticals sector.

Cowboys—and aside from my text I use that term loosely, because no horse wants to be sat on by me—choose machinery, computers, and high-technology medicines to assist the cows in their herds.

COUNCIL RESOLUTION DESIGNED TO IMPLEMENT THE OUTLINES OF AN INDUSTRIAL POLICY IN THE PHARMACEUTICAL SECTOR IN THE EUROPEAN UNION THE COUNCIL Having regard to the Commission communication of 14 September 1994 entitled "An industrial competitiveness policy for the European Union"; Recalling its Resolution of 21 November 1994 on strengthening the competitiveness of Community industry [10] , and its conclusions of 7 April 1995 on an industrial competitiveness policy; Having regard to the communication of 2 March 1994 from the Commission to the Council and the European Parliament on the outlines of an industrial policy for the pharmaceutical sector in the European Union; Whereas the European Union has an important role to play in creating a f ...[+++]avourable environment for the expansion of activities relating to research, development, production and distribution of medicinal products and in encouraging the development of an innovative and effective European pharmaceutical industry in terms of competitiveness on the world market; Whereas European industrial policy must necessarily take account of the special nature of this sector, which relates both to public health and to social policy; whereas social security systems bear a considerable proportion of pharmaceutical expenditure; whereas this is a matter which falls within the competence of the Member States; Whereas the European Union has the responsibility of sketching out guidelines for the promotion of Community activities in this sector, HAS ADOPTED THIS RESOLUTION: I. WITH RESPECT TO THE SITUATION IN THE PHARMACEUTICAL INDUSTRY 1. recalls that the European pharmaceutical industry plays an essential role in public health, remains a high-technology industry with considerable added value, which is particularly successful, generates highly skilled jobs and makes a significant contribution to the Union's balance of trade; 2. considers that, now that it is facing increasingly intense international competition, the Euro ...