24. 8. 93 Official Journal of the European Communities No L 214/31 COUNCIL DIRECTIVE 93/40/EEC of 14 June 1993 amending Directives 81/851/EEC and 81/852/EEC on the approximation of the laws of the Member States relating to veterinary 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 (1); In cooperation with the European Parliament (%), Having regard to the opinion of the Economic and Social Committee (), 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 movement of goods, persons, services and capital is ensured; Whereas despite the progress achieved by Council Directive 81/851/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products (*), further measures are necessary to abolish the remaining barriers to the free movement of veterinary medicinal products within the Community; Whereas, with the exception of those veterinary 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 veterinary 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 veterinary medicinal product concerned may present a risk to human or animal health, or to the environment; whereas, in the event of a disagreement between Member States about the quality, the safety or the efficacy of a (1) OJ No C 330, 31. 12. 1990, p. 25 and O] No C 310, 30. 11. 1991, p. 25. (3) O] No C 183, 15. 7. 1991, p. 194 and OJ No C 150, 31. 5. 1993. (>) O] No C 269, 14. 10. 1991, p. 84. (* O] No L 317, 6. 11. 1981, p. 1. Directive last amended by Directive 90/676/EEC of 13 December 1990 (O] No L 373, 31. 12. 1990, p. 15). (*) See page 1 of this Official Journal. veterinary medicinal product, a scientific evaluation of the matter should be undertaken by the Committee for Veterinary Medicinal Products attached to the European Agency for the Evaluation of Medicinal Products, lead to a single decision on the area of disagreement, binding on the Member States concerned; whereas this Decision should be adopted by a rapid procedure ensuring close cooperation between the Commission and the Member States; Whereas in order better to protect human and animal health and avoid any unnecessary duplication of effort during the examination of application for authorization to place veterinary medicinal products on the market, Member States should systematically prepare assessment reports in respect of each veterinary medicinal product which is authorized by them, and exchange the reports upon request; whereas, furthermore, a Member State should be able to suspend the examination of an application for authorization to place a veterinary medicinal product on the market which is currently under active consideration in another Member State with a view to recognizing the decision reached by the latter Member State; Whereas following the establishment of the internal market, specific controls to guarantee the quality of veterinary medicinal products imported from third countries can be waived only if appropriate arrangements have been made by the Community to ensure that the necessary controls are carried out in the exporting country; Whereas it is desirable to codify and improve the cooperation and exchange of information between Member States relating to the surveillance of veterinary medicinal products and in particular the monitoring of adverse reactions under practical conditions of use through the national pharmacovigilance systems; Whereas in order to improve the protection of public health it is necessary to specify that foodstuffs for human consumption may not be taken from animals which have been used in clinical trials of veterinary medicinal products unless a maximum residue limit has been laid down for residues of the veterinary medicinal product concerned in accordance with the provisions of Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin (), (®) OJ No L 224, 18. 8. 1990, p. 1. Regulation last amended by Regulation (EEC) No 762/92 (O] No L 83, 28. 3. 1992, p- 14). :