31.12.90 Official Journal of the European Communities No L 373/15 COUNCIL DIRECTIVE of 13 December 1990 amending Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products (90/676/EEC) ‘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 (1), In cooperation with the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas Article 23 (2) of Council Directive 81/851/EEC (#) provides that the Commission should submit to the Council a proposal containing appropriate measures leading towards the elimination of any remaining barriers to trade or to the _ free movement of veterinary medicinal products not later than four years after the implementation of the abovementioned Directive; Whereas the Directives on the approximation of laws relating to veterinary medicinal products must be adapted to scientific progress and improved to take account of the experience acquired since their adoption; Whereas it is necessary from the point of view of public health and the free movement of veterinary medicinal products for the competent authorities to have at their disposal all useful information on authorized veterinary medicinal products in the form of approved summaries of the characteristics of products; Whereas the approximation of laws brought about in this connection must enable a veterinary medicinal product, manufactured and placed on the market in one Member State on the basis of harmonized provisions, to be allowed into the other Member States, taking due consideration of the initial authorization, save in exceptional cases submitted for ah opinion to the Committee for Veterinary Medicinal Products set up by Directive 81/851/EEC; : Whereas the system for package inserts' accompanying veterinary medicinal products should be improved; Whereas it is advisable to stipulate more precisely the cases in which the results of pharmacological and toxicological tests or clinical trials do not have to be provided with a view to (1) OJNoC61,10.3.1989,p. 11 andO]NoC 131, 30 5.1990, p. 16. 2) O] No C 96,17. 4. 1990, p. 104 and Decision of 21 November 1990 (not yet published in the Official Journal). (3) O] No C201,7.8.1989,p. 1. () O] No L 317, 6. 11. 1981, p. 1. obtaining authorization for a veterinary medicinal product which is essentially similar to an innovative product, while ensuring that innovative firms are not placed at a disadvantage; whereas, however, there are reasons of public policy for not repeating tests carried out on animals without overriding cause; Whereas the guarantees of the quality of veterinary medicinal products manufactured within the Community should be maintained by requiring compliance with the principles of good manufacturing practice for medicinal products irrespective of the final destination of the products; Whereas the Commission should be empowered to define in detail principles of good manufacturing practice for veterinary medicinal products in close cooperation with the . Committee for Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers to Trade in the Veterinary Medicinal Products Sector established by Article 2b of Council Directive 81/852/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to analytical, pharmaco- toxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products (%), as amended by Directive 87/20/EEC (5); Whereas measures should be taken to improve the provision of information for third countries about the conditions of use of veterinary medicinal products within the Member States and the Community; . Whereas measures should also be taken to ensure that distributors of veterinary medicinal products are authorized by Member States and maintain adequate records, HAS ADOPTED THIS DIRECTIVE: A Article 1 Directive 81/851/EEC is hereby amended as follows: 1. Article 1 (5) is replaced by the following: ‘5. Member States shall take all measures necessary to ensure that only persons empowered under their national legislation in force possess or have under their control veterinary medicinal products or substances which may be used as veterinary medicinal products that have anabolic, anti-infectious, anti-parasitic, anti-inflammatory, hormonal or psychotropic properties. (5) OJ No L 317, 6. 11. 1981, p. 16. (5) OJ No L 15, 17. 1. 1987, p. 34.