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Changes over time for: Paragraph 7


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.
Status:
Point in time view as at 06/11/2023.
Changes to legislation:
The Medicines for Human Use (Clinical Trials) Regulations 2004, Paragraph 7 is up to date with all changes known to be in force on or before 04 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.

Changes to Legislation
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7.—(1) This sub-paragraph applies where—U.K.
(a)an application for a clinical trial certificate has been made in accordance with section 36 of the Act and the licensing authority has not before 1st May 2004 determined whether to issue a certificate;
(b)the licensing authority has received a notice pursuant to article 4(1)(a) of the Medicines (Exemption from Licences) (Clinical Trials) Order 1995 and on 1st May 2004—
(i)the specified period within the meaning of article 4(2) of that Order has not expired, and
(ii)the authority has not given or sent a notice pursuant to article 4(1)(b); or
(c)the licensing authority has received a notice pursuant to article 4(2)(iv) of the Medicines (Exemption from Licences) (Special Cases and Miscellaneous Provisions) Order 1972 and on 1st May 2004—
(i)the period specified in article (2)(v) of that Order has not expired, and
(ii)the authority has not given a direction pursuant to that article.
(2) Where sub-paragraph (1) applies the licensing authority shall treat the application or notice as a valid request for authorisation to conduct the clinical trial to which the application or notice relates under regulation 17.
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