- Latest available (Revised)
- Point in Time (01/05/2004)
- Original (As made)
The Medicines for Human Use (Clinical Trials) Regulations 2004
You are here:
- UK Statutory Instruments
- 2004 No. 1031
- PART 3
- Regulation 12
What Version
Advanced Features
- Show Geographical Extent(e.g. England, Wales, Scotland and Northern Ireland)
- Show Timeline of Changes
More Resources
Status:
Point in time view as at 01/05/2004. This version of this provision has been superseded.
Status
You are viewing this legislation item as it stood at a particular point in time. A later version of this or provision, including subsequent changes and effects, supersedes this version.
Note the term provision is used to describe a definable element in a piece of legislation that has legislative effect – such as a Part, Chapter or section.
Changes to legislation:
There are currently no known outstanding effects for the The Medicines for Human Use (Clinical Trials) Regulations 2004, Section 12.
Changes to Legislation
Revised legislation carried on this site may not be fully up to date. At the current time any known changes or effects made by subsequent legislation have been applied to the text of the legislation you are viewing by the editorial team. Please see ‘Frequently Asked Questions’ for details regarding the timescales for which new effects are identified and recorded on this site.
Requirement for authorisation and ethics committee opinionU.K.
12.—(1) No person shall—
(a)start a clinical trial or cause a clinical trial to be started; or
(b)conduct a clinical trial,
unless the conditions specified in paragraph (3) are satisfied.
(2) No person shall—
(a)recruit an individual to be a subject in a trial;
(b)issue an advertisement for the purpose of recruiting individuals to be subjects in a trial,
unless the condition specified in paragraph (3)(a) has been satisfied.
(3) The conditions referred to in paragraphs (1) and (2) are—
(a)an ethics committee or an appeal panel appointed under Schedule 4 has given a favourable opinion in relation to the clinical trial; and
(b)the clinical trial has been authorised by the licensing authority.
(4) For the purposes of these Regulations, a clinical trial has been authorised by the licensing authority if—
(a)in the case of a trial to which regulation 18 relates—
(i)the trial is to be treated as authorised by virtue of regulation 18, or
(ii)the authority has accepted the request for authorisation in accordance with the procedure specified in Schedule 5; or
(b)in the case of a clinical trial to which regulation 19 or 20 applies—
(i)the authority has given a notice of authorisation in accordance with those regulations, or
(ii)the authority has accepted the request for authorisation in accordance with the procedure specified in Schedule 5.
Options/Help
Print Options
PrintThe Whole Instrument
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.
Point in Time: This becomes available after navigating to view revised legislation as it stood at a certain point in time via Advanced Features > Show Timeline of Changes or via a point in time advanced search.
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.