# Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (Text with EEA relevance), Article 65: Manufacturing of auxiliary medicinal products

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

Where the auxiliary medicinal product is not authorised, or where an authorised auxiliary medicinal product is modified while such modification is not covered by a marketing authorisation, it shall be manufactured according to the good manufacturing practice referred to in Article 63(1) orto at least an equivalent standard, in order to ensure appropriate quality.

---
Source: https://www.legislation.gov.uk/eur/2014/536/article/65 (the official version)
Page: https://openlegislation.uk/eu-regulation-2014-536/article-65
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.