6. 11. 81 Official Journal of the European Communities No L 317/1 (Acts whose publication is not obligatory) COUNCIL COUNCIL DIRECTIVE of 28 September 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products (81/851/EEC) THE COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the Euro- pean Economic Community, and in particular Article 100 thereof, Having regard to the proposal from the Commis- sion (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (?), Whereas the primary purpose of any rules for the production and distribution of veterinary medicinal products must be the safeguarding of public health; Whereas, however, this objective must be achieved by means which will not hinder the development of industry and trade in medicinal products within the Community; Whereas, in so far as the Member States already have certain provisions laid down by law, regulation or administrative action governing veterinary medi- cinal products, such provisions differ in essential principles; whereas this results in the hindering of trade in medicinal products within the Community, thereby directly affecting the establishment and functioning of the common market; () OJ No C 152,5.7.1976, p. 1. () 0J No C 293, 13. 12. 1976, p. 64. (*) OJ No C 299, 18. 12. 1976, p. 12. Whereas such hindrances must, accordingly, be removed; whereas this entails approximation of the relevant provisions; Whereas the provisions of this Directive which con- cern veterinary medicinal products are, although appropriate, not adequate for veterinary medicinal products used to confer active immunity, to diag- nose the state of immunity and to confer passive immunity or for medicinal products based on radioactive isotopes; whereas it is therefore advis- able not to prescribe their application to such prod- ucts for the present; Whereas medicated feedingstuffs do not come within the scope of this Directive; whereas, how- ever, it is necessary, for both public health and economic reasons, to prohibit the use of unauthor- ized medicinal products in the manufacture of medicated feedingstuffs; Whereas marketing authorization shall be refused where a medicinal product lacks therapeutic effect or where there is insufficient proof of such effect; whereas the concept of therapeutic effect must be understood as being the effect promised by the manufacturers; Whereas such authorization shall also be refused where the withdrawal period indicated is not long enough to eliminate health hazards arising from residues;