# 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 89: Application for manufacturing authorisation

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

1. An application for a manufacturing authorisation shall be submitted to a competent authority in the Member State in which the manufacturing site is located.
2. An application for a manufacturing authorisation shall contain at least the following information:
(a) veterinary medicinal products which are to be manufactured or imported;
(b) name or company name and permanent address or registered place of business of the applicant;
(c) pharmaceutical forms which are to be manufactured or imported;
(d) details about the manufacturing site where the veterinary medicinal products are to be manufactured or imported;
(e) a statement to the effect that the applicant fulfils the requirements laid down in Articles 93 and 97.

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Source: https://www.legislation.gov.uk/eur/2019/6/article/89 (the official version)
Page: https://openlegislation.uk/eu-regulation-2019-6/article-89
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.