Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 22-23: Difference between revisions
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Revision as of 17:29, 15 July 2026
| Document information | |
|---|---|
| Reference | GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 |
| Validity area | GBR |
| Scope(s) | HM |
| Document name | The Medicines for Human Use (Clinical Trials) Regulations 2004 |
| Version / Revision | 01-May-2004 |
| Status | Current |
| Document type | Legal act |
| Language(s) | EN |
| Description | The Medicines for Human Use (Clinical Trials) Regulations 2004 |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 4 — Unit 4.4.0 |
| Scope | HM |
| Document part | Article 22-23 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Amendment, Sponsor, Competent authority, Clinical trial |
| Comment | Amendments to clinical trial authorisation: general rules |
Content
Amendments to clinical trial authorisation 22. Subject to regulation 30, an amendment to a clinical trial authorisation may be made—
(a)by the licensing authority, in accordance with regulation 23; or (b)by the sponsor, in accordance with regulation 24 or 25.
Amendments by the licensing authority 23.—(1) Subject to paragraphs (1) and (2), the licensing authority may make amendments to a clinical trial authorisation if it appears to the authority to be necessary to ensure—
(a)the safety or scientific validity of the clinical trial; or (b)that the conditions and principles of good clinical practice are satisfied or adhered to in relation to the clinical trial.
(2) Where the licensing authority propose to make an amendment in accordance with paragraph (1), the authority shall, at least 14 days before the date on which it is proposed the amendment should take effect, serve a notice on the sponsor stating their proposal and the reasons for it.
(3) If, within 14 days of the date a notice is served in accordance with paragraph (2), the sponsor makes representations in writing to the licensing authority, the authority—
(a)shall take those representations into account before deciding whether to make the amendment; and (b)may delay the date the proposed amendment is to take effect, in order to allow time for them to consider those representations.
