COUNCIL DIRECTIVE 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 (81/852/EEC)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof,
Having regard to the proposal from the Commission (1),
Whereas the approximation begun 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 (2) should continue and the principles laid down in that Directive should be implemented;
Whereas, among existing disparities, those relating to the control of veterinary medicinal products are of fundamental importance ; whereas point 10 of the second paragraph of Article 5 of Directive 81/851/EEC requires that applications for authorization to place a veterinary medicinal product on the market should be accompanied by particulars and documents relating to the results of tests and trials carried out on the product concerned;
Whereas standards and protocols for the performance of tests and trials on veterinary medicinal products are an effective means of control of these products and, hence, of protecting public health and can facilitate the movement of these products by laying down uniform rules applicable to tests and trials and the compilation of dossiers;
Whereas the adoption of the same standards and protocols by all the Member States will enable the competent authorities to arrive at their decisions on the basis of uniform tests and by reference to uniform criteria and will, therefore, help to obviate differences in evaluation;
Whereas the physico-chemical, biological or micro-biological tests provided for in point 10 of the second paragraph of Article 5 of Directive 81/851/EEC are closely related to points 3, 4, 6 and 9 of the said paragraph ; whereas it is necessary, therefore, to specify the data to be provided under those points;
Whereas the waiting period referred to in point 8 of the second paragraph of the said Article 5 of Directive 81/851/EEC must be determined in accordance with the results of the tests and trials provided for in point 10 thereof;
Whereas the concepts of harmfulness and therapeutic efficacy referred to in Article 11 of Directive 81/851/EEC can be examined only in relation to one another and have only a relative significance, depending on the progress of scientific knowledge and the use for which the medicinal product is intended ; whereas the particulars and documents which must accompany an application for authorization to place a veterinary medicinal product on the market must demonstrate that potential hazards are outweighed by the therapeutic efficacy of the product ; whereas, failing such demonstration, the application must be rejected;
Whereas it is the quality of the tests and trials which is pre-eminent ; whereas the tests and trials carried out pursuant to these provisions must, therefore, be taken into consideration, irrespective of the nationality of the experts who perform them and of the country in which they are carried out,
HAS ADOPTED THIS DIRECTIVE:
Article 1
Member States shall take all appropriate measures to ensure that the particulars and documents which shall accompany applications for authorization to place a veterinary medicinal product on the market, pursuant to points 3, 4, 6, 8, 9 and 10 of the second paragraph of Article 5 of Directive 81/851/EEC, are submitted by the persons concerned in accordance with the Annex to this Directive.
Where, pursuant to point 10 (a) or (b) of the second paragraph of Article 5 of the abovementioned (1) OJ No C 152, 5.7.1976, p. 11. (2) See page 1 of this Official Journal. Directive, references to published data are submitted, the provisions of this Directive shall apply in like manner.
Article 2
The Committee for Veterinary Medicinal Products referred to in Article 16 of Directive 81/851/EEC may examine any question relating to the application of this Directive.
Article 3
Member States shall bring into force the provisions necessary to comply with this Directive within 24 months following its notification and shall forthwith inform the Commission thereof.
Member States shall ensure that the texts of the main provisions of national law which they adopt in the field covered by this Directive are communicated to the Commission.
Article 4
This Directive is addressed to the Member States.
Done at Brussels, 28 September 1981.