4. Where a biological veterinary medicinal product which is similar to a reference biological veterinary medicinal product does not meet the conditions in the definition of generic medicinal products, owing to, in particular, differences relating to raw materials or in manufacturing processes of the biological veterinary medicinal product and the reference biological veterinary medicinal product, the results of appropriate pre-clinical tests or clinical trials relating to these conditions must be provided.

(4) Consolidated evidence including: freedom from disease affecting poultry; poultry disease surveillance and monitoring programmes; the development of appropriate contingency plans for poultry diseases; and, the development of the veterinary acquis in regard to general veterinary legislation and legislation in the poultry sector in advance of EU accession, has demonstrated that Estonia, Malta, Latvia and Lithuania have sufficiently well structured and organised veterinary services regarding the animal health status for live poultry and ratites.

4. Where a biological veterinary medicinal product which is similar to a reference biological veterinary medicinal product does not meet the conditions in the definition of generic medicinal products, owing to, in particular, differences relating to raw materials or in manufacturing processes of the biological veterinary medicinal product and the reference biological veterinary medicinal product, the results of appropriate pre-clinical tests or clinical trials relating to these conditions must be provided.

The following points (21 ) to (28 ) are added: Veterinary prescription Any prescription for veterinary medical products issued in writing by an authorised member of the veterinary profession after a clinical examination of the animal(s) or of a representative sample of the group of animals involved or in accordance with good veterinary practice .

Given the unanimous adoption by the European Parliament on 3 May (R5-0230/2001) of Mrs Doyle’s report (A5-0119/2001 ) on the availability of veterinary medicinal products; given the urgent need to have optimal protection for the consumer; given the urgent need on welfare, therapeutic and economic grounds for veterinarians to have access to the widest range of veterinary products to treat all food-producing animals; given the Commission’s approval of the principle of extrapolating maximum residue limits established for some species to other species as a short term solution to the problem and given the commitment made by Commissioner Li ...[+++]ikanen on the record in the parliamentary debate on veterinary medicinal products that he expected ‘legislative proposals to be finalised within a few months’;

Whereas, with the exception of those veterinary medicinal products which are subject to the centralized Community authorization procedure established by 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 (5), an authorization to place a veterinary medicinal product on the market in one Member State ought in principle to be recognized by the competent authorities of the other Member States unless there are serious grounds for supposing that th ...[+++]e authorization of the veterinary medicinal product concerned may present a risk to human or animal health, or to the environment; whereas, in the event of a disagreement between Member States about the quality, the safety or the efficacy of a veterinary medicinal product, a scientific evaluation of the matter should be undertaken by the Committee for Veterinary Medicinal Products attached to the European Agency for the Evaluation of Medicinal Products, lead to a single decision on the area of disagreement, binding on the Member States concerned; whereas this Decision should be adopted by a rapid procedure ensuring close cooperation between the Commission and the Member States;