No L 15/38 Official Journal of the European Communities 17. 1. 87 COUNCIL DIRECTIVE of 22 December 1986 on the approximation of national measures relating to the placing on the market of high-technology medicinal products, particularly those derived from biotechnology (87/22/EEC) THE COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof, Having regard to the proposal from the Commission ('), Having regard to the opinion of the European Parli- ament (%), Having regard to the opinion of the Economic and Social Committee (%), Whereas the essential aim of any rules governing the production and distribution of medicinal products must be to safeguard public health; Whereas high-technology medicinal products requiring lengthy periods of costly research will continue to be developed in Europe only if they benefit from a favourable regulatory environment, particularly identical conditions governing their placing on the market throughout the Community; Whereas Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (), as last amended by Directive 83/570/EEC (), makes provision for certain procedures for coordinating national decisions relating to the placing on the market of proprietary medicinal products for human use ; whereas pharmaceutical undertakings may, according to these provisions, request a Member State to take due account of an authorization already issued by another Member State ; Whereas Council Directive 81/851/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products (¥) makes provision for a procedure for coordinating national deci- sions relating to veterinary medicinal products; Whereas, however, these procedures are not sufficient to open up to high-technology medicinal products the large Community-wide single market they require ; () OJ No C 293, 5. 11. 1984, p. 1. () O] No C 36, 17. 2. 1986, p. 152. () OJ No C 160, 1. 7. 1985, p. 18. () OJ No L 147, 9. 6. 1975, p. 13. () OJ No L 332, 28. 11. 1983, p. 1. (9 O] No L 317, 6. 11. 1981, p. 1. Whereas, in this technically advanced sector, the scientific expertise available to each of the national authorities is not always sufficient to resolve problems posed by high- technology medicinal products; Whereas it is consequently important to provide for a Community mechanism for concertation, prior to any national decision relating to a high-technology medicinal product, with a view to arriving at uniform decisions throughout the Community ; | Whereas it is desirable to extend this Community concer- tation to immunological products and substitutes for blood constituents developed by means of new biotechno- logical processes, and to new products based on radio- isotopes, the development of which in Europe can only take place if a sufflcnently large and homogeneous market exists ; Whereas the need for the adoption of new technical rules applying to high-technology medicinal products or for the amendment of existing rules must be examined during a preliminary concertation between the Member States and the Commission within the competent Committees so as not to endanger the advance of phar- maceutical research whilst at the same time ensuring optimum protection of public health within the Commu- nity, HAS ADOPTED THIS DIRECTIVE: Article 1 Before taking a decision on a marketing authorization or on the withdrawal or, subject to Article 4 (2), suspension of a marketing authorization in respect of the medicinal products listed in the Annex, Member States’ authorities shall, in accordance with Articles 2, 3 and 4, refer the matter for an opinion to the Committees referred to in Article 8 of Directive 75/319/EEC and Article 16 of Directive 81/851/EEC. Article 2 1. As soon as they receive an application for marketing authorization relating to a medicinal product referred to in the Annex (Lists A and B), the competent authorities shall, at the request of the person responsible for placing the product on the market, bring the matter before either