# 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 68: Radiopharmaceuticals used as investigational medicinal products or as auxiliary medicinal products for a medical diagnosis

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

Articles 66 and 67 shall not apply to radiopharmaceuticals used as diagnostic investigational medicinal products or as diagnostic auxiliary medicinal products.
The products referred to in the first paragraph shall be labelled appropriately in order to ensure the safety of the subject and the reliability and robustness of data generated in the clinical trial.

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Source: https://www.legislation.gov.uk/eur/2014/536/article/68 (the official version)
Page: https://openlegislation.uk/eu-regulation-2014-536/article-68
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.