COUNCIL DIRECTIVE of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products (75/318/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;
Whereas the approximation begun by Council Directive 65/65/EEC (1) of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products should be continued and the implementation of the principles laid down in that Directive should be ensured;
Whereas among existing disparities those relating to the control of proprietary medicinal products are of fundamental importance and point 8 of Article 4, second paragraph of the said Directive requires that applications for authorization to place a proprietary 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 proprietary 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, the compilation of dossiers and the examination of applications;
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 avoid differences in evaluation;
Whereas the physico-chemical, biological or microbiological tests provided for in point 8 of Article 4, second paragraph, of Directive 65/65/EEC are closely related to points 3, 4, 6 and 7 of the same paragraph and it is therefore necessary to specify the data to be provided pursuant to these points;
Whereas the quality of the tests is the essential consideration ; whereas therefore tests carried out in accordance with these provisions must be taken into consideration irrespective of the nationality of the experts who perform them or the country in which they are carried out;
Whereas the concepts of "harmfulness" and "therapeutic efficacy" referred to in Article 5 of Directive 65/65/EEC can only be examined in relation to each other and have only a relative significance depending on the progress of scientific knowledge and the use for which the proprietary medicinal product is (1)OJ No 22, 9.2.1965, p. 369/65.
intended ; whereas the particulars and documents which must accompany an application for authorization to place a proprietary medicinal product on the market demonstrate that potential risks are outweighed by the therapeutic efficacy of the product ; whereas failing such demonstration, the application must be rejected;
Whereas the evaluation of "harmfulness" and "therapeutic efficacy" may be modified in the light of new discoveries and standards and protocols must be amended periodically to take account of scientific progress,
HAS ADOPTED THIS DIRECTIVE:
Article 1
Member States shall take all appropriate measures to ensure that the particulars and documents which must accompany applications for authorization to place a proprietary medicinal product on the market (marketing authorization), pursuant to points 3, 4, 6, 7 and 8 of Article 4, second paragraph, of Directive 65/65/EEC, are submitted by the persons concerned in accordance with the Annex to this Directive.
Where, pursuant to point 8 (a) and (b) of Article 4, second paragraph, of the abovementioned Directive, references to published data are submitted, the provisions of this Directive shall apply in like manner.
Article 2
Notwithstanding the provisions of other Directives on proprietary medicinal products, Member States shall take all appropriate measures to ensure that the competent authorities examine the particulars and documents submitted in support of applications for marketing authorization in accordance with the criteria of the Annex to this Directive.
Article 3
Member States shall bring into force the provisions needed in order to comply with this Directive within 18 months of its notification and shall forthwith inform the Commission thereof.
Member States shall ensure that they communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
Article 4
This Directive is addressed to the Member States.
Done at Brussels, 20 May 1975.