Judgment — ECLI:EU:C:2005:288
Date: 2005-05-12
Language of the case: German
Court formation: Second Chamber
Based on: Treaty establishing the European Economic Community (1957)
Subject matter: Approximation of laws
Concepts: Marketing authorisation
Procedure: Reference for a preliminary ruling
Origin: Germany

Summary of the Judgment Approximation of laws — Medicinal products — Marketing authorisation — Special, simplified registration procedure — Conditions — Medicinal product composed of several homeopathic substances — Requirement of proof of therapeutic efficacy — None (European Parliament and Council Directive 2001/83, Arts 14 and 15) Articles 14 and 15 of Directive 2001/83 on the Community code relating to medicinal products for human use must be interpreted as meaning that they preclude a national provision which does not permit use of the special simplified registration procedure for a medicinal product composed of several known homeopathic substances if its use as a homeopathic medicine is not generally known. As is apparent from Article 14(1) of Directive 2001/83, read in conjunction with Article 1(5), a homeopathic medicinal product may be subject to the special simplified registration procedure in so far as it is administered orally or externally, no specific therapeutic indication appears on the labelling of the medicinal product or in any information relating thereto and, finally, there is a sufficient degree of dilution to guarantee its safety. In accordance with Article 15 of that directive, only the homeopathic stock or stocks from which that combination is derived must be well-known. However, that provision does not require the submission of a bibliography showing that the effects of the homeopathic medicinal product itself have been identified. As regards proof of therapeutic efficacy, Article 14(3) of that directive expressly states that such proof is not required for homeopathic medicinal products registered in accordance with paragraph (1) of that article. (see paras 16, 20, 22, 26, operative part)