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The Medicines for Human Use (Clinical Trials) Regulations 2004

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Changes over time for: Paragraph 9

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The Medicines for Human Use (Clinical Trials) Regulations 2004, Paragraph 9 is up to date with all changes known to be in force on or before 27 February 2025. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations. Help about Changes to Legislation

9.  A description of the arrangements—U.K.

(a)for maintaining production or importation records;

(b)for maintaining records of analytical and other testing procedures applied in the course of manufacture, assembly or importation for ensuring compliance of materials used in the manufacture of any investigational medicinal products with the specification of such materials or medicinal products; and

(c)for keeping reference samples of materials used in the manufacture of any investigational medicinal products and of the investigational medicinal products.

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