CELEX: 51990PC0283(04)
Language: en
Date: 1990-11-14
Title: PROPOSAL FOR A COUNCIL DIRECTIVE REPEALING DIRECTIVE 87/22/EEC ON THE APPROXIMATION OF NATIONAL MEASURES RELATING TO THE PLACING ON THE MARKET OF HIGH TECHNOLOGY MEDICINAL PRODUCTS PARTICULARLY THOSE DERIVED FROM BIOTECHNOLOGY

No C 330/32                                       Official Journal of the European Communities                                      31. 12. 90
                        Proposal for the Council Directive repealing Directive 87/22/EEC on the approximation of national
                        measures relating to the placing on the market of high technology medicinal products particularly
                                                         those derived from biotechnology
                                                          COM(90) 283 final — SYN 312
                                              (Submitted by the Commission on 14 November 1990)
                                                                   (90/C 330/04)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,                                      marketing authorization which have been referred to
                                                                               Committee for Proprietary Medicinal Products or the
Having regard the Treaty establishing the European                             Committee for Veterinary Medicinal Products in accordance
Economic Community, and in particular Article 100a                            with Directive 87/22/EEC before 1 January 1993,
thereof,
Having regard to the proposal from the Commission,
                                                                               HAS ADOPTED THIS DIRECTIVE:
In cooperation with the European Parliament,
                                                                                                         Article 1
Having regard to the opinion of the Economic and Social
Committee,                                                                    With effect from 1 January 1993, Council Directive
                                                                               87/22/EEC is repealed.
Whereas the provision of Council Directive 8 7 / 2 2 / E E C p )
have now been superseded by the provisions of Regulation
(EEC) No . . . of . . . laying down Community procedures                                                 Article 2
for the authorization and supervision of medicinal products
for human and veterinary use and establishing a European                      Applications for marketing authorization which have been
Agency for the Evaluation of Medicinal Products (2) and by                     referred to the Committee for Proprietary Medicinal
Council Directive 88/182/EEC of 22 March 1988                                  Products or to the Committee for Veterinary Medicinal
amending Directive 83/189/EEC laying down a procedure                          Products before 1 January 1993 in accordance with Article 2
for the provision of information in the field of technical                     of Directive 87/22/EEC and in respect of which the
standards and regulations (3);                                                 Committee concerned has not given an opinion by 1 January
                                                                               1993 shall be considered in accordance with Regulation
Whereas provision has been made in Council Directive                           (EEC) No . . .
 . . . / . . . / . . . ( 4 ) for the continued management of
marketing authorizations which have been granted by
Member States following the opinion of the Committee for                                                 Article 3
Proprietary Medicinal Products given in accordance with
Directive 87/22/EEC;                                                          Member States shall take all appropriate measures to comply
                                                                               with this Directive before 1 January 1993. They shall
Whereas, futhermore, provision has been made in Council                        forthwith inform the Commission thereof.
Directive . . . / . . . / . . . (5) for the continued management of
marketing authorizations which have been granted by                           When Member States adopt these provisions, these shall
Member States following the opinion of the Committee for                      contain a reference to this Directive or shall be accompanied
Veterinary Medicinal Products given in accordance with                        by such reference at the time of their official publication. The
Directive 87/22/EEC;                                                          procedure for such reference shall be adopted by Member
                                                                              States.
Whereas Directive                87/22/EEC      should   therefore   be
repealed;
                                                                                                         Article 4
Whereas in the interests of legal certainty, provision should
be made for the continued examination of applications for                     This Directive is addressed to the Member States.
0)    OJ No L 15, 17. 1. 1987, p. 38.
(2)    See page 1 of this Official Journal.
(3)   OJ No L 81. 26. 3. 1988, p. 75.
(«)   OJ No L . . .
(J)   OJ No L . . .