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The Medicines for Human Use (Clinical Trials) Regulations 2004
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Changes to legislation:
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 12 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.
Changes to Legislation
Revised legislation carried on this site may not be fully up to date. Changes and effects are recorded by our editorial team in lists which can be found in the ‘Changes to Legislation’ area. Where those effects have yet to be applied to the text of the legislation by the editorial team they are also listed alongside the legislation in the affected provisions. Use the ‘more’ link to open the changes and effects relevant to the provision you are viewing.
Changes and effects yet to be applied to Schedule 6 Paragraph 9:
- Sch. 6 para. 4(1A)(1B) inserted by S.I. 2025/87 reg. 51(4)(b)
- Sch. 6 para. 4(2A)(2B) inserted by S.I. 2025/87 reg. 51(4)(c)
- Sch. 6 para. 10 11 inserted by S.I. 2025/87 reg. 51(5)
- Sch. 7 Pt. 2A 2B inserted by S.I. 2025/87 reg. 52(7)
- Sch. 7 Pt. 2 para. 2A 2B inserted by S.I. 2025/87 reg. 52(4)
- Sch. 7 Pt. 2 para. 6A 6B inserted by S.I. 2025/87 reg. 52(6)
- Sch. 7 Pt. 2 para. 2(b) words inserted by S.I. 2025/87 reg. 52(3)
- reg. 13(2)(b)(ia)(ib) inserted by S.I. 2025/87 reg. 40(3)
- reg. 36(1A) inserted by S.I. 2025/87 reg. 41(3)
- reg. 36(3)(4) inserted by S.I. 2025/87 reg. 41(4)
- reg. 36A 36B inserted by S.I. 2025/87 reg. 42
- reg. 39(4A)(4B) inserted by S.I. 2025/87 reg. 43
- reg. 44(9)-(14) inserted by S.I. 2025/87 reg. 45
- reg. 44A 44B inserted by S.I. 2025/87 reg. 46
- reg. 45(2)(c)(d) inserted by S.I. 2025/87 reg. 47(2)(b)
- reg. 45(5)(6) inserted by S.I. 2025/87 reg. 47(3)
- reg. 46(3) inserted by S.I. 2025/87 reg. 48
- reg. 49(1)(ka)(kb) inserted by S.I. 2025/87 reg. 50
Changes and effects yet to be applied to the whole Instrument associated Parts and Chapters:
Whole provisions yet to be inserted into this Instrument (including any effects on those provisions):
- Sch. 6 para. 4(1A)(1B) inserted by S.I. 2025/87 reg. 51(4)(b)
- Sch. 6 para. 4(2A)(2B) inserted by S.I. 2025/87 reg. 51(4)(c)
- Sch. 6 para. 10 11 inserted by S.I. 2025/87 reg. 51(5)
- Sch. 7 Pt. 2A 2B inserted by S.I. 2025/87 reg. 52(7)
- Sch. 7 Pt. 2 para. 2A 2B inserted by S.I. 2025/87 reg. 52(4)
- Sch. 7 Pt. 2 para. 6A 6B inserted by S.I. 2025/87 reg. 52(6)
- Sch. 7 Pt. 2 para. 2(b) words inserted by S.I. 2025/87 reg. 52(3)
- reg. 13(2)(b)(ia)(ib) inserted by S.I. 2025/87 reg. 40(3)
- reg. 36(1A) inserted by S.I. 2025/87 reg. 41(3)
- reg. 36(3)(4) inserted by S.I. 2025/87 reg. 41(4)
- reg. 36A 36B inserted by S.I. 2025/87 reg. 42
- reg. 39(4A)(4B) inserted by S.I. 2025/87 reg. 43
- reg. 44(9)-(14) inserted by S.I. 2025/87 reg. 45
- reg. 44A 44B inserted by S.I. 2025/87 reg. 46
- reg. 45(2)(c)(d) inserted by S.I. 2025/87 reg. 47(2)(b)
- reg. 45(5)(6) inserted by S.I. 2025/87 reg. 47(3)
- reg. 46(3) inserted by S.I. 2025/87 reg. 48
- reg. 49(1)(ka)(kb) inserted by S.I. 2025/87 reg. 50
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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