Olainfarm AS v Latvijas Republikas Veselības ministrija and Zāļu valsts aģentūra.
Date: 2014-10-23
26. Article 10a of Directive 2001/83 therefore has the effect of exempting the applicant from one of the requirements laid down in Article 8 of the directive for obtaining a MA under Article 6 thereof. Accordingly, a medicinal product for which the MA was granted pursuant to Article 10a of the directive, the applicant for that authorisation having availed himself of the derogation under that provision and also having fulfilled all the other requirements laid down in Article 8 of the directive, must be regarded as a medicinal product authorised under Article 6 of the directive, in accordance with the provision of Article 8 thereof.
27. In that regard, it should be observed, first, that the purpose of the requirement for applicants seeking marketing authorisation to attach to their application the results of preclinical tests and clinical trials, laid down in Article 8(3)(i) of Directive 2001/83, is to provide proof of the safety and efficacy of the medicinal product concerned (see, to that effect, judgment in Generics (UK) , C‑527/07, EU:C:2009:379, paragraph 22 and the case-law cited).
28. Second, bearing in mind in particular the fact that the essential aim of any rules governing the production and distribution of medicinal products must be to safeguard public health, as stated in recital 2 in the preamble to Directive 2001/83, the concept of a ‘reference medicinal product’, within the meaning of Article 10(2)(a) of that directive, cannot be interpreted in such a way that the abridged procedure provided for in that article amounts to a relaxation of the requirements of safety and efficacy which must be met by medicinal products (judgment in Generics (UK) , EU:C:2009:379, paragraph 24 and the case-law cited). It is therefore essential, in order for it to be possible to grant a marketing authorisation for a generic medicinal product on the basis of the abridged procedure, that all the particulars and documents relating to the reference product and demonstrating its safety and efficacy should remain available to the competent authority concerned by the application for authorisation (see, to that effect, judgment in Generics (UK) , EU:C:2009:379, paragraph 25 and the case-law cited).
29. As 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.