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Regulation (EU) No 536/2014 of the European Parliament and of the CouncilShow full title
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)
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Article 63Manufacturing and import
1.Investigational medicinal products shall be manufactured by applying manufacturing practice which ensures the quality of such medicinal products in order to safeguard the safety of the subject and the reliability and robustness of clinical data generated in the clinical trial (‘good manufacturing practice’). The Commission shall be empowered to adopt delegated acts in accordance with Article 89 in order to specify the principles and guidelines of good manufacturing practice and the detailed arrangements for inspection for ensuring the quality of investigational medicinal products, taking account of subject safety or data reliability and robustness, technical progress and global regulatory developments in which the Union or the Member States are involved.
In addition, the Commission shall also adopt and publish detailed guidelines in line with those principles of good manufacturing practice and revise them when necessary in order to take account of technical and scientific progress.
2.Paragraph 1 shall not apply to the processes referred to in Article 61(5).
3.Investigational medicinal products imported into the Union shall be manufactured by applying quality standards at least equivalent to those laid down pursuant to paragraph 1.
4.The Member States shall ensure compliance with the requirements of this Article by means of inspections.
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