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.