WRITTEN QUESTION E-1572/02

by Reimer Böge (PPE-DE) to the Commission

(4 June 2002)

Subject: Registration of alternative remedies in veterinary medicine

There is a growing interest among both breeders and consumers in the use of homeopathy and other alternative therapies in the keeping of farm animals, particularly those used for food. Given the increasingly criticised use of antibiotics, etc., this trend is to be welcomed. However, veterinary practitioners have complained that, under Directive 92/74/EEC(1) of 22 September 1992, the simplified registration of homeopathic remedies for farm animals is no longer admissible and that plant-based remedies must even go through the entire registration procedure.

What is the Commission's opinion of the experiences with the registration procedure under Directive 92/74/EEC?

Does it believe that it is possible to simplify the registration procedure for alternative remedies in the field of veterinary medicine?

(1) OJ L 297, 13.10.1992, p. 12.

Answer given by Mr Liikanen on behalf of the Commission

(27 June 2002)

The functioning of the two simplified registration procedures for human and veterinary homeopathic medicinal products, which were established in 1992 by Council Directives 92/73/EEC and 92/74/EEC of 22 September 1992, has been analysed and evaluated in the Commission Report to the Parliament and Council on the Application of Directive 92/73/EEC and 92/74/EEC of 14 July 1997(1). This analysis was based on an in-depth study on the application of both Directives in the human and the veterinary sector, performed by independent consultants. The report concludes that the two Directives have contributed to achieve a certain, but not yet satisfying degree of harmonisation. In order to prepare possible legislative amendments, the report invited the Parliament and the Council to express their views on certain issues like the scope of the simplified registration procedure or the obligation to mutually recognise registrations granted by other Member States.

Taking into account such views, the Commission does see the possibility to improve the registration procedure for homeopathic medicinal products. The Commission's proposal to review the Community's pharmaceutical legislation(2) of 26 November 2001 contains a number of amendments, that relate to the registration of human and veterinary homeopathic medicinal products. It is proposed to oblige the Member States to establish a simplified registration procedure, whereas at present it is an option only. Furthermore, the scope of the simplified registration procedure is widened in so far as the strict limitation to non-food producing animals is deleted, referring however to the provisions of Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure

for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin(3). Furthermore, the soft obligation to take due account of registrations and authorisations previously granted by another Member State is turned to a clear obligation to initiate a particular mutual recognition procedure, obliging the Member States to use their best endeavours to reach agreement within the newly established coordination group.

(1) COM(97) 362 final.

(2) OJ C 75 E, 26.3.2002.

(3) OJ L 224, 18.8.1990.