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, 
Having regard the Treaty establishing the European 
Economic Community, and in particular Article 100a 
thereof, 
Having regard to the proposal from the Commission, 
In cooperation with the European Parliament, 
Having regard to the opinion of the Economic and Social 
Committee, 
Whereas the provision of Council Directive 87/22/EECp) 
have now been superseded by the provisions of Regulation 
(EEC) No . . . of . . . 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 (2) and by 
Council Directive 88/182/EEC of 22 March 1988 
amending Directive 83/189/EEC laying down a procedure 
for the provision of information in the field of technical 
standards and regulations (3); 
Whereas provision has been made in Council Directive 
.../.../...(4) for the continued management of 
marketing authorizations which have been granted by 
Member States following the opinion of the Committee for 
Proprietary Medicinal Products given in accordance with 
Directive 87/22/EEC; 
Whereas, futhermore, provision has been made in Council 
Directive . ../.../... (5) for the continued management of 
marketing authorizations which have been granted by 
Member States following the opinion of the Committee for 
Veterinary Medicinal Products given in accordance with 
Directive 87/22/EEC; 
Whereas Directive 87/22/EEC should therefore be 
repealed; 
Whereas in the interests of legal certainty, provision should 
be made for the continued examination of applications for marketing authorization which have been referred to 
Committee for Proprietary Medicinal Products or the 
Committee for Veterinary Medicinal Products in accordance 
with Directive 87/22/EEC before 1 January 1993, 
HAS ADOPTED THIS DIRECTIVE: 
Article 1 
With effect from 1 January 1993, Council Directive 
87/22/EEC is repealed. 
Article 2 
Applications for marketing authorization which have been 
referred to the Committee for Proprietary Medicinal 
Products or to the Committee for Veterinary Medicinal 
Products before 1 January 1993 in accordance with Article 2 
of Directive 87/22/EEC and in respect of which the 
Committee concerned has not given an opinion by 1 January 
1993 shall be considered in accordance with Regulation 
(EEC) No . . . 
Article 3 
Member States shall take all appropriate measures to comply 
with this Directive before 1 January 1993. They shall 
forthwith inform the Commission thereof. 
When Member States adopt these provisions, these shall 
contain a reference to this Directive or shall be accompanied 
by such reference at the time of their official publication. The 
procedure for such reference shall be adopted by Member 
States. 
Article 4 
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 . . .