92001E0916

WRITTEN QUESTION E-0916/01

by Ilda Figueiredo (GUE/NGL) to the Commission

(28 March 2001)

Subject: Recombinant vaccine

The Portuguese Hunting Federation has told the European Agency for Medicinal Products that the recombinant vaccine for the control of viral haemorrhagic disease and mixomatosis in wild rabbits needs to be made available as soon as possible.

According to the Federation this vaccine must be licensed as soon as possible so that it can be marketed, since the rabbit population has already been decimated by the above-mentioned diseases.

Can the Commission therefore say what measures are to be taken to solve the problem of these diseases in rabbits?

Joint answer to Written Questions E-0916/01 and P-1200/01 given by Mr Liikanen on behalf of the Commission

(11 May 2001)

The two rabbit diseases mentioned by the Honourable Member are not compulsory notifiable by the Member States to the Commission and the wild rabbit is not an endangered species.

The scientific evaluation of any individual application for marketing authorisation of a veterinary medicinal product submitted to the European Medicines Evaluation Agency in accordance with Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products(1) is the responsibility of the Committee for Veterinary Medicinal Products. The Commission thereafter receives an opinion of the Committee on the quality, safety and efficacy of the product within a specific time frame and proceeds on the basis of this opinion, to draw up a draft decision to be adopted in accordance with the procedure laid down in Article 73 in the aforementioned Regulation. However, the Commission may in no way interfere in the scientific evaluation process.

(1) OJ L 214, 24.8.1993.