The Queen, on the application of Generics (UK) Ltd v Licensing Authority.
Date: 2009-06-18
22. In order to reply to that question, it should be recalled, at the outset, that the objective of the obligation on applicants seeking marketing authorisation for a medicinal product, to attach to the application the results of toxicological and pharmacological tests, and clinical trials, referred to in Article 8(3)(i) of Directive 2001/83, is to provide proof of the safety and efficacy of a medicinal product (see, to that effect, Case C‑440/93 Scotia Pharmaceuticals [1995] ECR I‑2851, paragraph 17, and Case C‑368/96 Generics (UK)  and Others [1998] ECR I‑7967, paragraph 23).
23. It should also be borne in mind that the abridged procedure established by Article 10 of that directive – which relieves applicants seeking marketing authorisation for a generic of a reference medicinal product already authorised in accordance with that directive from having to provide the results of the aforementioned tests and trials – has, inter alia, as its objective, as is apparent from recital 10 in the preamble to Directive 2001/83, to avoid the repetition of tests on humans or animals where not absolutely necessary ( Generics (UK) and Others , paragraphs 4 and 71).
24. Having regard in particular to the fact that, as is stated in recital 2 in the preamble to Directive 2001/83, the essential aim of any rules governing the production and distribution of medicinal products must be to safeguard public health, 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 that abridged procedure amounts to a relaxation of the requirements of safety and efficacy which must be met by medicinal products (see, to that effect, Scotia Pharmaceuticals , paragraphs 17 and 22, and Generics (UK) and Others , paragraph 22).
25. Thus, in order to be able to grant a marketing authorisation for a generic medicinal product on the basis of the abridged procedure, what matters is that all the particulars and documents relating to the reference medicinal product remain available to the competent authority concerned by the application for authorisation (see, to that effect, Case C‑223/01 AstraZeneca [2003] ECR I‑11809, paragraph 27).
27. In other words, it is only in the case where the competent authority has all the particulars and documents relating to the reference medicinal product that Article 10(1) of Directive 2001/83 replaces the obligation on applicants for marketing authorisation to provide results of the tests and trials referred to in Article 8(3)(i) of that directive with the obligation to demonstrate that the medicinal product in question is so similar to that reference medicinal product, which already benefits from such an authorisation, that it does not differ significantly from that product as regards safety and efficacy (see, to that effect, Generics (UK) and Others , paragraphs 23 and 24).
30. It is apparent both from the wording and from the broad logic of Directive 2001/83, in particular from Articles 6, 8 and 10, that only those medicinal products benefiting from a marketing authorisation issued in accordance with that directive can be considered to be reference medicinal products. Likewise, as regards medicinal products for which marketing authorisation was sought prior to the entry into force of that directive, it is clear from the case-law that, in order to benefit from the abridged procedure, the applicant must show that the reference medicinal product was authorised on the basis of the Community law in force at the time of the application for marketing authorisation for the reference medicinal product (see, to that effect, AstraZeneca , paragraph 23).