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- Submit previous sponsor's written agreement when referencing their applications
Retained EU Law
2014
United Kingdom
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)
At a glance
What's here
37 compliance obligations
Who this Act binds
Plus 5 non-business duties on Crown ministers, regulators, local authorities or tribunals — shown collapsed under each section below.
What this Act requires
Sections that create concrete duties on businesses or carry penalties. Procedural and definitional sections are folded into the “Browse other sections” expander at the bottom of each group. Click any section title to read the source text on legislation.gov.uk.
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- Provide sponsor responsibility details for multi-sponsor clinical trials
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- Sponsor must label low-intervention trials and provide justification in cover letter
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- Include reasons in protocol if single safety report is intended
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- Provide a data protection compliance statement
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- Report medication errors, pregnancies and misuse as adverse reactions
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- Set and maintain Reference Safety Information (RSI) for clinical trials
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- Submit complete SUSAR reports within strict deadlines
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- Sponsor must control unblinding of treatment allocation in clinical trials
Submission of an application
- Submit clinical trial application through EU portal and propose a reporting Member State
Assessment report — Aspects covered by Part I
Other duties (1) — Crown / regulator
- Reporting Member State must assess clinical trial application and issue final assessment report Statutory regulator
Assessment report — Aspects covered by Part II
Other duties (1) — Crown / regulator
- Competent authority must assess clinical trial application (Part II) within 45 days Statutory regulator
Subsequent addition of a Member State concerned
- Submit application dossier when extending clinical trial to another UK nation
Submission of application
- Submit clinical trial application dossier through EU portal
Assessment of a substantial modification of an aspect covered by Part I of the assessment report
Other duties (1) — Crown / regulator
- Regulator must assess substantial modification applications within 38 days Statutory regulator
Validation, assessment and decision regarding a substantial modification of an aspect covered by Part II of the assessment report
Other duties (1) — Crown / regulator
- Member State must validate and decide on substantial modification within statutory timelines Statutory regulator
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
Other duties (1) — Crown / regulator
- Regulator must assess substantial clinical trial modification and report within 38 days Statutory regulator
Notification of the start of a clinical trial and of the end of the recruitment of subjects
- Notify Member States of clinical trial milestones via EU portal within 15 days
End of a clinical trial, temporary halt and early termination of a clinical trial and submission of the results
- Notify EU portal and submit clinical trial results
Reporting of adverse events and serious adverse events by the investigator to the sponsor
- Keep detailed records of all adverse events reported by the investigator
Reporting of suspected unexpected serious adverse reactions by the sponsor to the Agency
- Report suspected unexpected serious adverse reactions to the EU database
Annual reporting by the sponsor to the Agency
- Submit annual safety reports for each investigational medicinal product
Compliance with the protocol and good clinical practice
- Run clinical trials according to protocol and good clinical practice
Monitoring
- Adequately monitor clinical trial conduct
Reporting of serious breaches
- Report serious breaches in clinical trials within 7 days
Other reporting obligations relevant for subject safety
- Report unexpected events affecting benefit-risk balance and submit third-country inspection reports
Urgent safety measures
- Take urgent safety measures and notify the MHRA within 7 days
Investigator's brochure
- Provide and keep updated the investigator's brochure for clinical trials
Recording, processing, handling and storage of information
- Record and protect clinical trial information and personal data
Clinical trial master file
- Keep a clinical trial master file with essential documents
Archiving of the clinical trial master file
- Archive clinical trial master file for 25 years after trial end
Auxiliary medicinal products
- Use only authorised auxiliary medicinal products in clinical trials unless exception applies
Responsibilities of the qualified person
- Ensure qualified person certifies each batch of investigational medicinal product and provide certification to regulators
Co-sponsorship
- Allocate responsibilities among co-sponsors in a written contract
Legal representative of the sponsor in the Union
- Appoint a legal representative in the UK for EU-based clinical trials
Damage compensation
- Ensure compensation insurance is in place and used for clinical trial participants
EU database
- Keep the EU database updated with non-substantial trial changes
Browse 89 other sections — procedural / definitional / commencement
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uri:annex/i/division/d/division/20
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uri:annex/iii/division/2/division/2.3/division/10
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uri:annex/vi/division/a/division/a.1/division/1
uri:annex/vi/division/a/division/a.2/division/a.2.1/division/4
uri:annex/vi/division/a/division/a.2/division/a.2.2/division/5
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The summary of the results of the clinical trial shall...
The summary of the results of the clinical trial for...
Clinical trial identification (including title of the trial, protocol number,...
Scope
Definitions
General principle
Prior authorisation
Decision on the clinical trial
Persons assessing the application
Specific considerations for vulnerable populations
Submission and assessment of applications limited to aspects covered by Part I or Part II of the assessment report
Withdrawal
Resubmission
General principles
Validation of an application for the authorisation of a substantial modification of an aspect covered by Part I of the assessment report
Decision on the substantial modification of an aspect covered by Part I of the assessment report
Substantial modification of aspects covered by Parts I and II of the assessment report
Decision on the substantial modification of aspects covered by Parts I and II of the assessment report
Persons assessing the application for a substantial modification
Data submitted in the application dossier
Language requirements
Update by way of delegated acts
General rules
Informed consent
Informed consent in cluster trials
Clinical trials on incapacitated subjects
Clinical trials on minors
Clinical trials on pregnant or breastfeeding women
Additional national measures
Clinical trials in emergency situations
Temporary halt or early termination by the sponsor for reasons of subject safety
Update of the contents of the summary of results and summary for laypersons
Electronic database for safety reporting
Assessment by Member States
Technical aspects
Reporting with regard to auxiliary medicinal products
Suitability of individuals involved in conducting the clinical trial
Suitability of clinical trial sites
Traceability, storage, return and destruction of investigational medicinal products
Scope of this Chapter
Authorisation of manufacturing and import
Manufacturing and import
Modification of authorised investigational medicinal products
Manufacturing of auxiliary medicinal products
Unauthorised investigational and unauthorised auxiliary medicinal products
Authorised investigational and authorised auxiliary medicinal products
Radiopharmaceuticals used as investigational medicinal products or as auxiliary medicinal products for a medical diagnosis
Language
Delegated act
Sponsor
Principal investigator
Liability
Corrective measures to be taken by Member States
Member State inspections
Union controls
EU portal
Functionality of the EU portal and the EU database
National contact points
Support by the Agency and the Commission
Clinical Trials Coordination and Advisory Group
General principle
One payment per activity per Member State
Committee procedure
Exercise of the delegation
Specific requirements for special groups of medicinal products
Relation with other Union legislation
Investigational medicinal products, other products and procedures, free of charge for the subject
Data protection
Penalties
Civil and criminal liability
Repeal
Review
Transitional provision
Entry into force
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