Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 5 (5)
From GxPlex
| 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 6 — Unit 6.1.2 |
| Scope | HM |
| Document part | Schedule 5
(5) |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Authorisation revocation, Temporary halt, Early termination, Competent authority, Amendment |
| Comment | Procedural provisions on refusal or amendment of authorisation |
Content
PROCEDURAL PROVISIONS RELATING TO THE REFUSAL OR AMENDMENT OF, OR IMPOSITION OF CONDITIONS RELATING TO, CLINICAL TRIAL AUTHORISATION AND THE SUSPENSION OR TERMINATION OF CLINICAL TRIALS 1.— […] (5) In the case of a notice to suspend or terminate a trial, the licensing authority shall, after considering the report of the appropriate committee or the Commission, confirm or revoke the notice. [...] 3.— [...] (4) The decisions to which this paragraph applies are decisions of the licensing authority— (a)to confirm— (i)that they have grounds for not accepting a request for authorisation or an amendment to the clinical trial authorisation, (ii)their decision to impose a condition, or (iii)the notice to suspend or terminate the trial,against the advice of the Medicines Commission under paragraph 1(2);
