- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Gwreiddiol (Fel y’i mabwysiadwyd gan yr UE)
Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (Text with EEA relevance)
Mae unrhyw newidiadau sydd wedi cael eu gwneud yn barod gan y tîm yn ymddangos yn y cynnwys a chyfeirir atynt gydag anodiadau.Ar ôl y diwrnod ymadael bydd tair fersiwn o’r ddeddfwriaeth yma i’w gwirio at ddibenion gwahanol. Y fersiwn legislation.gov.uk yw’r fersiwn sy’n weithredol yn y Deyrnas Unedig. Y Fersiwn UE sydd ar EUR-lex ar hyn o bryd yw’r fersiwn sy’n weithredol yn yr UE h.y. efallai y bydd arnoch angen y fersiwn hon os byddwch yn gweithredu busnes yn yr UE.
Y fersiwn yn yr archif ar y we yw’r fersiwn swyddogol o’r ddeddfwriaeth fel yr oedd ar y diwrnod ymadael cyn cael ei chyhoeddi ar legislation.gov.uk ac unrhyw newidiadau ac effeithiau a weithredwyd yn y Deyrnas Unedig wedyn. Mae’r archif ar y we hefyd yn cynnwys cyfraith achos a ffurfiau mewn ieithoedd eraill o EUR-Lex.
There are currently no known outstanding effects for the Regulation (EU) No 536/2014 of the European Parliament and of the Council.
Revised legislation carried on this site may not be fully up to date. At the current time any known changes or effects made by subsequent legislation have been applied to the text of the legislation you are viewing by the editorial team. Please see ‘Frequently Asked Questions’ for details regarding the timescales for which new effects are identified and recorded on this site.
CHAPTER III AUTHORISATION PROCEDURE FOR A SUBSTANTIAL MODIFICATION OF A CLINICAL TRIAL
Article 17.Validation of an application for the authorisation of a substantial modification of an aspect covered by Part I of the assessment report
Article 18.Assessment of a substantial modification of an aspect covered by Part I of the assessment report
Article 19.Decision on the substantial modification of an aspect covered by Part I of the assessment report
Article 20.Validation, assessment and decision regarding a substantial modification of an aspect covered by Part II of the assessment report
Article 21.Substantial modification of aspects covered by Parts I and II of the assessment report
Article 22.Assessment of a substantial modification of aspects covered by Parts I and II of the assessment report — Assessment of the aspects covered by Part II of the assessment report
Article 23.Decision on the substantial modification of aspects covered by Parts I and II of the assessment report
Article 24.Persons assessing the application for a substantial modification
CHAPTER VI START, END, TEMPORARY HALT, AND EARLY TERMINATION OF A CLINICAL TRIAL
Article 36.Notification of the start of a clinical trial and of the end of the recruitment of subjects
Article 37.End of a clinical trial, temporary halt and early termination of a clinical trial and submission of the results
Article 38.Temporary halt or early termination by the sponsor for reasons of subject safety
Article 39.Update of the contents of the summary of results and summary for laypersons
CHAPTER VII SAFETY REPORTING IN THE CONTEXT OF A CLINICAL TRIAL
Article 47.Compliance with the protocol and good clinical practice
Article 49.Suitability of individuals involved in conducting the clinical trial
Article 51.Traceability, storage, return and destruction of investigational medicinal products
Article 53.Other reporting obligations relevant for subject safety
Article 56.Recording, processing, handling and storage of information
CHAPTER XIII SUPERVISION BY MEMBER STATES, UNION INSPECTIONS AND CONTROLS
APPLICATION DOSSIER FOR THE INITIAL APPLICATION
6. The cover letter shall specify the EU trial number and...
8. The cover letter shall indicate where the information listed in...
9. The cover letter shall indicate if the clinical trial is...
10. The cover letter shall indicate if the methodology of the...
11. The cover letter shall indicate the location in the application...
12. In the case of a resubmission, the cover letter shall...
14. The protocol shall describe the objective, design, methodology, statistical considerations,...
16. The protocol shall, when possible, be written in an easily...
18. If a clinical trial is conducted with an active substance...
19. With regard to the notification of adverse events, the protocol...
21. In case the sponsor intends to submit a single safety...
22. Issues regarding labelling and the unblinding of investigational medicinal products...
23. The protocol shall be accompanied by the Charter of the...
24. The protocol shall be accompanied by a synopsis of the...
F. DOCUMENTATION RELATING TO COMPLIANCE WITH GOOD MANUFACTURING PRACTICE (GMP) FOR...
31. As regards documentation relating to GMP compliance, the following shall...
32. No documentation needs to be submitted where the investigational medicinal...
33. If the investigational medicinal product is not authorised, and does...
34. In all other cases, a copy of the authorisation referred...
35. For processes related to investigational medicinal products set out in...
G. INVESTIGATIONAL MEDICINAL PRODUCT DOSSIER (IMPD)
36. The IMPD shall give information on the quality of any...
1.1. Data relating to the investigational medicinal product
Non-clinical pharmacology and toxicology data
41. The IMPD shall also contain summaries of non-clinical pharmacology and...
42. Non-clinical pharmacology and toxicology data shall be submitted in a...
43. The IMPD shall provide a critical analysis of the data,...
44. The IMPD shall contain a statement of the good laboratory...
45. The test material used in toxicity studies shall be representative...
I. SCIENTIFIC ADVICE AND PAEDIATRIC INVESTIGATION PLAN (PIP)
J. CONTENT OF THE LABELLING OF THE INVESTIGATIONAL MEDICINAL PRODUCTS
K. RECRUITMENT ARRANGEMENTS (INFORMATION PER MEMBER STATE CONCERNED)
L. SUBJECT INFORMATION, INFORMED CONSENT FORM AND INFORMED CONSENT PROCEDURE (INFORMATION...
M. SUITABILITY OF THE INVESTIGATOR (INFORMATION PER MEMBER STATE CONCERNED)
N. SUITABILITY OF THE FACILITIES (INFORMATION PER MEMBER STATE CONCERNED)
O. PROOF OF INSURANCE COVER OR INDEMNIFICATION (INFORMATION PER MEMBER STATE...
P. FINANCIAL AND OTHER ARRANGEMENTS (INFORMATION PER MEMBER STATE CONCERNED)
Q. PROOF OF PAYMENT OF FEE (INFORMATION PER MEMBER STATE CONCERNED)...
R. PROOF THAT DATA WILL BE PROCESSED IN COMPLIANCE WITH UNION...
1. REPORTING OF SERIOUS ADVERSE EVENTS BY THE INVESTIGATOR TO THE...
2. REPORTING OF SUSPECTED UNEXPECTED SERIOUS ADVERSE REACTIONS (SUSARS) BY THE...
CONTENT OF THE SUMMARY OF THE RESULTS OF THE CLINICAL TRIAL FOR LAYPERSONS
LABELLING OF INVESTIGATIONAL MEDICINAL PRODUCTS AND AUXILIARY MEDICINAL PRODUCTS
The Whole Regulation you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.
Would you like to continue?
Y Diweddaraf sydd Ar Gael (diwygiedig):Y fersiwn ddiweddaraf sydd ar gael o’r ddeddfwriaeth yn cynnwys newidiadau a wnaed gan ddeddfwriaeth ddilynol ac wedi eu gweithredu gan ein tîm golygyddol. Gellir gweld y newidiadau nad ydym wedi eu gweithredu i’r testun eto yn yr ardal ‘Newidiadau i Ddeddfwriaeth’.
Gwreiddiol (Fel y’i mabwysiadwyd gan yr UE): Mae'r wreiddiol version of the legislation as it stood when it was first adopted in the EU. No changes have been applied to the text.
Gallwch wneud defnydd o ddogfennau atodol hanfodol a gwybodaeth ar gyfer yr eitem ddeddfwriaeth o’r tab hwn. Yn ddibynnol ar yr eitem ddeddfwriaeth sydd i’w gweld, gallai hyn gynnwys:
Mae’r llinell amser yma yn dangos y fersiynau gwahanol a gymerwyd o EUR-Lex yn ogystal ag unrhyw fersiynau dilynol a grëwyd ar ôl y diwrnod ymadael o ganlyniad i newidiadau a wnaed gan ddeddfwriaeth y Deyrnas Unedig.
Cymerir dyddiadau fersiynau’r UE o ddyddiadau’r dogfennau ar EUR-Lex ac efallai na fyddant yn cyfateb â’r adeg pan ddaeth y newidiadau i rym ar gyfer y ddogfen.
Ar gyfer unrhyw fersiynau a grëwyd ar ôl y diwrnod ymadael o ganlyniad i newidiadau a wnaed gan ddeddfwriaeth y Deyrnas Unedig, bydd y dyddiad yn cyd-fynd â’r dyddiad cynharaf y daeth y newid (e.e. ychwanegiad, diddymiad neu gyfnewidiad) a weithredwyd i rym. Am ragor o wybodaeth gweler ein canllaw i ddeddfwriaeth ddiwygiedig ar Ddeall Deddfwriaeth.
Defnyddiwch y ddewislen hon i agor dogfennau hanfodol sy’n cyd-fynd â’r ddeddfwriaeth a gwybodaeth am yr eitem hon o ddeddfwriaeth. Gan ddibynnu ar yr eitem o ddeddfwriaeth sy’n cael ei gweld gall hyn gynnwys:
liciwch ‘Gweld Mwy’ neu ddewis ‘Rhagor o Adnoddau’ am wybodaeth ychwanegol gan gynnwys