Opinion of the Advocate General — ECLI:EU:C:2004:541
Date: 2004-09-16
Language of the case: Danish
Based on: Treaty establishing the European Economic Community (1957)
Subject matter: Approximation of laws
Procedure: Reference for a preliminary ruling
Origin: Denmark

Summary of the Judgment 1. Approximation of laws – Medicinal products – Marketing authorisation – Abridged procedure – Essentially similar products – Medicine containing the same therapeutic moiety as the reference product but combined with another salt – Whether permissible – Conditions (Council Directive 65/65, Art. 4.8(a)(iii)) 2. Approximation of laws – Medicinal products – Marketing authorisation – Abridged procedure – Essentially similar products – Proof of similarity – Results of pharmacological and toxicological tests or clinical trials – Whether permissible (Council Directive 65/65, Art. 4.8(a)(iii)) 1. On a proper interpretation of Article 4.8(a)(iii) of Directive 65/65 on medicines, as amended by Directives 87/21, 89/341 and 93/39, which permits recourse to an abridged procedure for issuing marketing authorisations for medicines if the medicine for which such authorisation is applied for is essentially similar to a product which has been authorised within the Community, in accordance with Community provisions in force, for not less than six or ten years and is marketed in the Member State for which the application is made, such an application for authorisation may be handled under that abridged procedure where that product contains the same therapeutic moiety as the reference product but combined with another salt. There can be no such similarity if, for reasons specifically identified, there are grounds for believing that there is a significant difference from the reference medicine as regards the safety or efficacy of the product for which the marketing authorisation is sought. (see paras 39, 44, operative part 1) 2. In support of an application under Article 4.8(a)(iii) of Directive 65/65 on medicines, as amended by Directives 87/21, 89/341 and 93/39, an applicant may, either spontaneously or at the request of the competent authority of a Member State, supply additional documentation in the form of certain pharmacological and toxicological tests or clinical trials in order to demonstrate that his product is essentially similar to the reference product. (see para. 25, operative part 2)