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Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 2 12.: 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=3
|RefDocPart=Schedule 1
|unit=3.4.2
|scope=HM
|doc_part=Schedule 1
Part 2
Part 2
12.
12.
|RefLanguage=EN
|language=EN
|RefTagsEN=
|entry_by=Florian Adragna
|RefTagsOriginal=
|contributors=
|RefTagsFR=
|tags=TAG-00043-Goo-tek ++ TAG-00035-Man-odu ++ TAG-00011-Inv-tud ++ TAG-00132-Goo-rst ++ TAG-00095-Sto-ung
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|tags_display=[[Glossary:TAG-00043-Goo-tek|Good clinical practice]], [[Glossary:TAG-00035-Man-odu|Manufacturing]], [[Glossary:TAG-00011-Inv-tud|Investigational drug (IMP)]], [[Glossary:TAG-00132-Goo-rst|Good manufacturing practice]], [[Glossary:TAG-00095-Sto-ung|IMP storage]]
 
|comment=GCP principles: responsibilities for IMP management
{{:Document:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004}}
|content=CONDITIONS AND PRINCIPLES WHICH APPLY TO ALL CLINICAL TRIALS
 
{| class="wikitable gplx-infobox"
|-
! colspan="2" class="gplx-infobox-header" | Reference Details
|-
! Scope
| HM
|-
! Document part
| Schedule 1
Part 2
12.
|-
! Language
| EN
|-
! Original entry by
| Florian Adragna
|-
! Contributors
|
|-
! Tags (EN)
|
|-
! Tags (original language)
|
|-
! Tags (FR)
|  
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! Comment
| GCP principles: responsibilities for IMP management
|}
 
== Content ==
CONDITIONS AND PRINCIPLES WHICH APPLY TO ALL CLINICAL TRIALS
Principles based on International Conference on Harmonisation GCP Guideline
Principles based on International Conference on Harmonisation GCP Guideline
[...]
[...]
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(a)manufactured or imported, and handled and stored, in accordance with the principles and guidelines of good manufacturing practice, and
(a)manufactured or imported, and handled and stored, in accordance with the principles and guidelines of good manufacturing practice, and
(b)used in accordance with the approved protocol.
(b)used in accordance with the approved protocol.
}}

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 3 — Unit 3.4.2
Scope HM
Document part Schedule 1

Part 2 12.

Language EN
Original entry by Florian Adragna
Contributors
Tags Good clinical practice, Manufacturing, Investigational drug (IMP), Good manufacturing practice, IMP storage

Content

CONDITIONS AND PRINCIPLES WHICH APPLY TO ALL CLINICAL TRIALS Principles based on International Conference on Harmonisation GCP Guideline [...] 12. Investigational medicinal products used in the trial shall be— (a)manufactured or imported, and handled and stored, in accordance with the principles and guidelines of good manufacturing practice, and (b)used in accordance with the approved protocol.

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