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1. Centralised marketing authorisations shall be valid throughout the Union.

2. Centralised marketing authorisation procedure shall apply in respect of the following veterinary medicinal products:

(a) veterinary medicinal products developed by means of one of the following biotechnological processes:

(i) recombinant DNA technology;

(ii) controlled expression of genes coding for biologically active proteins in prokaryotes and eukaryotes including transformed mammalian cells;

(iii) hybridoma and monoclonal antibody methods;

(b) veterinary medicinal products intended primarily for use as performance enhancers in order to promote the growth of treated animals or to increase yields from treated animals;

(c) veterinary medicinal products containing an active substance which has not been authorised as a veterinary medicinal product within the Union at the date of the submission of the application;

(d) biological veterinary medicinal products which contain or consist of engineered allogeneic tissues or cells;

(e) novel therapy veterinary medicinal products.

3. Points (d) and (e) of paragraph 2 shall not apply to veterinary medicinal products consisting exclusively of blood components.

4. For veterinary medicinal products other than those referred to in paragraph 2, a centralised marketing authorisation may be granted if no other marketing authorisation has been granted for the veterinary medicinal product within the Union.