No L 214/22 Official Journal of the European Communities 24.8.93 (Acts whose publication is not obligatory) COUNCIL COUNCIL DIRECTIVE 93/39/EEC of 14 June 1993 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC in respect of medicinal products THE COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to 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 (3), Whereas it is important to adopt measures with the aim of progressively establishing the internal market over a period expiring on 31 December 1992; whereas the internal market shall comprise an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured; Whereas Article 15 (2) of Second 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 (*) provides that the Commission shall submit to the Council a proposal containing appropriate measures leading towards the abolition of any remaining barriers to the free movement of proprietary medicinal products; Whereas, in the interest of public health and of the consumer of medicinal products, it is necessary that decisions on the authorization to place medicinal products on the market be exclusively based on the (') OJ No C 330, 31. 12. 1970, p. 18, and O] No C 310, 30. 11. 1991, p. 22. (*) O] No C 183, 15. 7. 1991, p. 187, and O] No C 150, 31. 5. 1993. (®) OJ No C 269, 14. 10. 1991, p. 84. () O] No L 147, 9. 6. 1975, p. 13. Directive last amended by Directive 92/27/EEC (O] No L 113, 30. 4. 1992, p. 8). criteria of quality, safety and efficacy; whereas these criteria_have been extensively harmonized by Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administration action relating to medicinal products (°), by Council Directive 75/319/EEC, and by Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of medicinal products (); whereas, however, Member States should exceptionally be able to prohibit the use on their territory of medicinal products which infringe objectively defined concepts of public order or public morality; Whereas, with the exception of those medicinal products which are subject to the centralized Community authorization  procedure established by  Council Regulation (EEC) No 2309/93 of 22 July 1993 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 (), an authorization to place a medicinal product on the market in one Member State ought in principle to be recognized by the competent authorities of the other Member States unless there are serious grounds for supposing that the authorization of the medicinal product concerned may present a risk to public health; whereas, in the event of a disagreement between Member States about the quality, the safety or the efficacy of a medicinal product, a scientific evaluation of the matter should be undertaken by the Committee for Proprietary Medicinal Products attached to the European Agency for the Evaluation of Medicinal Products, leading to a single decision on the area of disagreement binding on the Member States (*) O] No 22, 9. 2. 1965, p. 369/65. Directive last amended by Directive 92/27/EEC (O] No L 113, 30. 4. 1992, p. 8). {®) O] No L 147, 9. 6. 1975, p. 1. Directive last amended by Commission Directive 91/507/EEC (O] No L 270, 26. 9. 1991, p. 32). () See page 1 of this Official Journal.