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Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 5 (5): Difference between revisions

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{{#set:
{{ReferenceData
|HasDocument=Document:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
|has_document=Document:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
|RefScope=HM
|module=6
|RefDocPart=Schedule 5
|unit=6.1.2
|scope=HM
|doc_part=Schedule 5
(5)
(5)
|RefLanguage=EN
|language=EN
|RefTagsEN=
|entry_by=Florian Adragna
|RefTagsOriginal=
|contributors=
|RefTagsFR=
|tags=TAG-00269-Wit-der ++ TAG-00039-Tem-ung ++ TAG-00038-Ear-tig ++ TAG-00057-Com-deR ++ TAG-00041-Ame-run
}}
|tags_display=[[Glossary:TAG-00269-Wit-der|Authorisation revocation]], [[Glossary:TAG-00039-Tem-ung|Temporary halt]], [[Glossary:TAG-00038-Ear-tig|Early termination]], [[Glossary:TAG-00057-Com-deR|Competent authority]], [[Glossary:TAG-00041-Ame-run|Amendment]]
Β 
|comment=Procedural provisions on refusal or amendment of authorisation
{{:Document:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004}}
|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
Β 
{| class="wikitable gplx-infobox"
|-
! colspan="2" class="gplx-infobox-header" | Reference Details
|-
! Scope
| HM
|-
! Document part
| Schedule 5
(5)
|-
! Language
| EN
|-
! Original entry by
| Florian Adragna
|-
! Contributors
|
|-
! Tags (EN)
|
|-
! Tags (original language)
|
|-
! Tags (FR)
| Β 
|-
! Comment
| Procedural provisions on refusal or amendment of authorisation
|}
Β 
== 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.β€” […]
1.β€” […]
(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.
(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.
Line 56: Line 22:
(ii)their decision to impose a condition, or
(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);
(iii)the notice to suspend or terminate the trial,against the advice of the Medicines Commission under paragraph 1(2);
}}

Latest revision as of 13:50, 16 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 6 β€” 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

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.β€” […] (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.β€” [...] (4) The decisions to which this paragraph applies are decisions of the licensing authorityβ€” (a)to confirmβ€” (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);

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