# 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 59: Auxiliary medicinal products

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

1. Only authorised auxiliary medicinal products may be used in a clinical trial.
2. Paragraph 1 shall not apply where no authorised auxiliary medicinal product is available in the Union or where the sponsor cannot reasonably be expected to use an authorised auxiliary medicinal product. A justification to this effect shall be included in the protocol.
3. Member States shall ensure that unauthorised auxiliary medicinal products may enter their territories for the purpose of their use in a clinical trial in accordance with paragraph 2.

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Source: https://www.legislation.gov.uk/eur/2014/536/article/59 (the official version)
Page: https://openlegislation.uk/eu-regulation-2014-536/article-59
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.