# 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 125: Certificate of suitability

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

In order to verify whether the data submitted for obtaining a certificate of suitability complies with the monographs of the European Pharmacopoeia, the standardisation body for nomenclatures and quality norms within the meaning of the Convention on the elaboration of a European Pharmacopoeia accepted by Council Decision 94/358/EC (European Directorate for the Quality of Medicines and Healthcare (‘EDQM’)) may ask the Commission or the Agency to request an inspection by a competent authority when the starting material concerned is subject to a European Pharmacopoeia monograph.

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Source: https://www.legislation.gov.uk/eur/2019/6/article/125 (the official version)
Page: https://openlegislation.uk/eu-regulation-2019-6/article-125
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.