- Latest available (Revised)
- Original (As made)
The Medicines for Human Use (Clinical Trials) Regulations 2004
You are here:
What Version
Advanced Features
- Show Geographical Extent(e.g. England, Wales, Scotland and Northern Ireland)
- Show Timeline of Changes
More Resources
Changes to legislation:
The Medicines for Human Use (Clinical Trials) Regulations 2004, Paragraph 12 is up to date with all changes known to be in force on or before 22 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 10 Part 1 Paragraph 12:
- 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
12. In section 44 of the Act (provision of information to licensing authority), in subsections (1) and (2), for “a clinical trial certificate or animal test certificate” substitute “ an animal test certificate ”.U.K.
Options/Help
Print Options
PrintThe Whole Instrument
PrintThe Whole Schedule
PrintThe Whole Part
PrintThis Section only
You have chosen to open The Whole Instrument
The Whole Instrument you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.
Would you like to continue?
You have chosen to open The Whole Instrument as a PDF
The Whole Instrument you have selected contains over 200 provisions and might take some time to download.
Would you like to continue?
You have chosen to open the Whole Instrument
The Whole Instrument you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.
Would you like to continue?
You have chosen to open Schedules only
The Schedules you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.
Would you like to continue?
Legislation is available in different versions:
Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.
Original (As Enacted or Made): The original version of the legislation as it stood when it was enacted or made. No changes have been applied to the text.
See additional information alongside the content
Geographical Extent: Indicates the geographical area that this provision applies to. For further information see ‘Frequently Asked Questions’.
Show Timeline of Changes: See how this legislation has or could change over time. Turning this feature on will show extra navigation options to go to these specific points in time. Return to the latest available version by using the controls above in the What Version box.
Opening Options
Different options to open legislation in order to view more content on screen at once
More Resources
Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:
- the original print PDF of the as enacted version that was used for the print copy
- lists of changes made by and/or affecting this legislation item
- confers power and blanket amendment details
- all formats of all associated documents
- correction slips
- links to related legislation and further information resources
Timeline of Changes
This timeline shows the different points in time where a change occurred. The dates will coincide with the earliest date on which the change (e.g an insertion, a repeal or a substitution) that was applied came into force. The first date in the timeline will usually be the earliest date when the provision came into force. In some cases the first date is 01/02/1991 (or for Northern Ireland legislation 01/01/2006). This date is our basedate. No versions before this date are available. For further information see the Editorial Practice Guide and Glossary under Help.
More Resources
Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:
- the original print PDF of the as made version that was used for the print copy
- correction slips
Click 'View More' or select 'More Resources' tab for additional information including:
- lists of changes made by and/or affecting this legislation item
- confers power and blanket amendment details
- all formats of all associated documents
- links to related legislation and further information resources
All content is available under the Open Government Licence v3.0 except where otherwise stated. This site additionally contains content derived from EUR-Lex, reused under the terms of the Commission Decision 2011/833/EU on the reuse of documents from the EU institutions. For more information see the EUR-Lex public statement on re-use.