Opinion of the Advocate General — ECLI:EU:C:2009:197
Date: 2009-03-26
Language of the case: English
Based on: Treaty establishing the European Economic Community (1957)
Subject matter: Approximation of laws;Public health
Procedure: Reference for a preliminary ruling
Origin: United Kingdom

Summary of the Judgment Approximation of laws – Medicinal products for human use (European Parliament and Council Regulation No 726/2004; European Parliament and Council Directive 2001/83, Art. 10(2)(a)) A medicinal product which falls outside the scope of Regulation No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and the placing of which on the market in a Member State was not authorised in accordance with the applicable Community law, cannot be considered to be a reference medicinal product within the meaning of Article 10(2)(a) of Directive 2001/83 on the Community code relating to medicinal products for human use, as amended by Directive 2004/27. In order that a medicinal product may be considered to be a reference medicinal product, it must have been authorised in accordance with Community law before being placed on the market. 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 that authorisation was sought prior to the entry into force of that directive, 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. 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 paras 27, 30, 33, 37, operative part)