# Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (Text with EEA relevance), Article 42: Scope of the centralised marketing authorisation procedure

Extent: E+W+S+N.I.

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.

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Source: https://www.legislation.gov.uk/eur/2019/6/article/42 (the official version)
Page: https://openlegislation.uk/eu-regulation-2019-6/article-42
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.