29As regards Article 10a of Directive 2001/83, it should be noted in the first place that the procedure governed by that provision does not provide for any relaxation of the requirements of safety and efficacy which must be met by medicinal products, that procedure being simply designed to reduce the preparation period for a MA application by relieving the applicant of the obligation to perform the preclinical tests and clinical trials referred to in Article 8(3)(i) of Directive 2001/83, provided that it is established by means of appropriate scientific literature, in accordance with the requirements laid down in Section 1 of Part II of Annex I to the directive, that those tests and trials have been carried out previously and have demonstrated that the constituent or constituents of the medicinal product concerned satisfy the criteria set out in Article 10a (see, with regard to the comparable provision in Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (OJ English Special Edition 1965-1966, p. 20), as amended by Council Directive 87/21/EEC of 22 December 1986 (OJ 1987 L 15, p. 36), judgment in Scotia Pharmaceuticals, C‑440/93, EU:C:1995:307, paragraph 17). Accordingly, as observed by the Advocate General at point 39 of his Opinion, such a medicinal product may be placed on the market only after the competent authority has verified its safety and efficacy.
Source: EUR-Lex, © European Union, 1998-2026. Reuse authorised under Decision 2011/833/EU.