# 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), Division 33: If the investigational medicinal product is not authorised, and does not have a marketing authorisation from a third country that is party to the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), and is not manufactured in the Union, the following documentation shall be submitted:

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

(a) a copy of the authorisation referred to in Article 61; and
(b) certification by the qualified person in the Union that the manufacturing complies with GMP at least equivalent to the GMP in the Union, unless there are specific arrangements provided for in mutual recognition agreements between the Union and third countries.

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Source: https://www.legislation.gov.uk/eur/2014/536/annex/I/division/F/division/33 (the official version)
Page: https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-F/division-33
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.