WRITTEN QUESTION E-2380/01

by Jan Mulder (ELDR) to the Commission

(8 August 2001)

Subject: Authorisations for the use of veterinary medicinal products

Pursuant to Council Directive 93/40/EEC(1), authorisations may be granted for the use of veterinary medicinal products in the EU. Such authorisations include conditions, identical throughout the EU, imposed on the use of veterinary medicinal products.

In addition, a large number of veterinary medicinal products are registered in the Member States. However, in this instance, the conditions imposed on the use of identical veterinary medicinal products vary from one Member State to another. That concerns in particular the withdrawal period applicable between the administration of a veterinary medicinal product and the time when an animal may be slaughtered and/or products from that animal consumed.

1. Does the Commission feel that, in the interests of food safety and consumer protection, withdrawal periods applicable to identical veterinary medicinal products should be uniform throughout the EU?

2. Does it agree that an action plan for the harmonisation, at European level, of withdrawal periods applicable to veterinary medicinal products should be introduced as rapidly as possible?

3. By what date does the Commission think that such harmonisation might be introduced?

(1) OJ L 214, 24.8.1993, p. 31.

Answer given by Mr Liikanen on behalf of the Commission

(24 October 2001)

Veterinary medicinal products covered by a centralised marketing authorisation, granted under Council Regulation No 2309/93(1), are subject to a harmonised withdrawal period in the Community.

Likewise, veterinary medicinal products marketed in several Member States according to the mutual recognition procedure put in place by Council Directive 93/40/EEC(2) also have to be subject to an identical withdrawal period in all the Member States concerned.

However, very many veterinary medicinal products in the Member States were authorised for the first time before the above-mentioned Regulation and Directive came into force. Consequently, certain medicinal products are likely to have formulations and compositions which are exactly the same in qualitative and quantitative terms in several Member States and to have been authorised for identical conditions of use (same dosage, same method of administration, same species), while being subject to different withdrawal periods depending on the Member State.

1. However, the Commission does not consider that it is essential to harmonise the withdrawal periods of these medicinal products in order to ensure food safety and consumer protection. This objective is already met by Council Regulation (EEC) No 2377/90 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin(3); it is on the basis of these limits that the withdrawal periods are established.

2. Nevertheless, the Commission acknowledges that, if identical medicinal products are available in several Member States with different conditions of use, a more coherent approach is required. In order to complete the single market and tackle the problem of the availability of veterinary medicinal products, the Commission has decided to proposed to the Council and to the Parliament the putting in place of a process aimed at gradually harmonising the summary product characteristics of these older medicinal products, including the withdrawal periods. This measure comes under the more general framework of proposals aimed at revising veterinary pharmaceutical legislation, the material content of which was adopted by the Commission in July 2001.

3. However, the Commission is not in a position to assess the times necessary for this harmonisation. These times will be directly dependent on the number and type of any products concerned.

(1) Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products, OJ L 214, 24.8.1993.

(2) Council Directive 93/40/EEC of 14 June 1993, amending Directives 81/851/EEC and 81/852/EEC on the approx;imation of the laws of the Member States relating to veterinary medicinal products, OJ L 214, 24.8.1993.

(3) 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, OJ L 224, 18.8.1990.