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The Medicines for Human Use (Clinical Trials) Regulations 2004
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Changes over time for: Paragraph 9
Alternative versions:
- 01/05/2004- Amendment
- 14/08/2012- Amendment
- 15/04/2022- Amendment
- 06/11/2023
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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 02 March 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.
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9. Where the holder of the authorisation has been informed by the licensing authority that any batch of any investigational medicinal product [F1or EAMS medicinal product] to which his authorisation relates has been found not to conform as regards strength, quality or purity with—U.K.
(a)the specification of the relevant product; or
(b)the provisions of these Regulations, [F2or the 2012 Regulations] that are applicable to the investigational medicinal product [F1or EAMS medicinal product],
he shall, if so directed, withhold such batch from distribution for use in clinical trials [F3or as part of the Early Access to Medicines Scheme], so far as may be reasonably practicable, for such a period not exceeding six weeks as may be specified by the licensing authority.
Textual Amendments
F1Words in Sch. 7 Pt. 2 para. 9 inserted (15.4.2022) by The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 (S.I. 2022/352), regs. 1(2), 18(2)(c)(i) (with reg. 19)
F2Words in Sch. 7 Pt. 2 para. 9 substituted (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 62(a)(ii) (with Sch. 32)
F3Words in Sch. 7 Pt. 2 para. 9 inserted (15.4.2022) by The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 (S.I. 2022/352), regs. 1(2), 18(2)(c)(ii) (with reg. 19)
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