Retained EU Law SI 2014/536 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)

Read it on legislation.gov.uk (opens in a new tab)
Status
In Force
Penalty ceiling
Regulated

Does it bind you?

Business-side roles with duties under this instrument.

Any Person28 Employer2 Data Controller2

Plus 5 duties on the regulator, Crown ministers and public bodies — folded into the section list below.

Other Acts binding the same actors

If a role above is yours, these are the other instruments that most often bind it.

Any Person — also bound by 2340 other Acts
Employer — also bound by 682 other Acts
TULRCA 1992 72 duties
Data Controller — also bound by 35 other Acts

What it requires

Regulations creating concrete business duties or carrying penalties, grouped as the instrument is structured. Titles link to the source text — blue means you’re leaving for legislation.gov.uk.

uri:annex/i/division/a/division/1 uri:annex/i/division/a/division/1 Regulated
  • Submit previous sponsor's written agreement when referencing their applicationsAny Person
uri:annex/i/division/a/division/2 uri:annex/i/division/a/division/2 Regulated
  • Provide sponsor responsibility details for multi-sponsor clinical trialsAny Person
uri:annex/i/division/b/division/9 uri:annex/i/division/b/division/9 Regulated
  • Sponsor must label low-intervention trials and provide justification in cover letterAny Person
uri:annex/i/division/d/division/21 uri:annex/i/division/d/division/21 Regulated
  • Include reasons in protocol if single safety report is intendedAny Person
uri:annex/i/division/r uri:annex/i/division/r Regulated
  • Provide a data protection compliance statementData Controller
uri:annex/iii/division/2/division/2.1 uri:annex/iii/division/2/division/2.1 Regulated
  • Report medication errors, pregnancies and misuse as adverse reactionsAny Person
uri:annex/iii/division/2/division/2.2 uri:annex/iii/division/2/division/2.2 Regulated
  • Set and maintain Reference Safety Information (RSI) for clinical trialsAny Person
uri:annex/iii/division/2/division/2.4 uri:annex/iii/division/2/division/2.4 Regulated
  • Submit complete SUSAR reports within strict deadlinesAny Person
uri:annex/iii/division/2/division/2.5 uri:annex/iii/division/2/division/2.5 Regulated
  • Sponsor must control unblinding of treatment allocation in clinical trialsAny Person
s.art005 Submission of an application Regulated
  • Submit clinical trial application through EU portal and propose a reporting Member StateAny Person
s.art006 Assessment report — Aspects covered by Part I Regulated
Other duties (1) — Crown / regulator
  • Reporting Member State must assess clinical trial application and issue final assessment reportStatutory regulator
s.art007 Assessment report — Aspects covered by Part II Regulated
Other duties (1) — Crown / regulator
  • Competent authority must assess clinical trial application (Part II) within 45 daysStatutory regulator
s.art014 Subsequent addition of a Member State concerned Regulated
  • Submit application dossier when extending clinical trial to another UK nationAny Person
s.art016 Submission of application Regulated
  • Submit clinical trial application dossier through EU portalAny Person
s.art018 Assessment of a substantial modification of an aspect covered by Part I of the assessment report Regulated
Other duties (1) — Crown / regulator
  • Regulator must assess substantial modification applications within 38 daysStatutory regulator
s.art020 Validation, assessment and decision regarding a substantial modification of an aspect covered by Part II of the assessment report Regulated
Other duties (1) — Crown / regulator
  • Member State must validate and decide on substantial modification within statutory timelinesStatutory regulator
s.art022 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 Regulated
Other duties (1) — Crown / regulator
  • Regulator must assess substantial clinical trial modification and report within 38 daysStatutory regulator
s.art036 Notification of the start of a clinical trial and of the end of the recruitment of subjects Regulated
  • Notify Member States of clinical trial milestones via EU portal within 15 daysAny Person
s.art037 End of a clinical trial, temporary halt and early termination of a clinical trial and submission of the results Regulated
  • Notify EU portal and submit clinical trial resultsAny Person
s.art041 Reporting of adverse events and serious adverse events by the investigator to the sponsor Regulated
  • Keep detailed records of all adverse events reported by the investigatorAny Person
s.art042 Reporting of suspected unexpected serious adverse reactions by the sponsor to the Agency Regulated
  • Report suspected unexpected serious adverse reactions to the EU databaseAny Person
s.art043 Annual reporting by the sponsor to the Agency Regulated
  • Submit annual safety reports for each investigational medicinal productAny Person
s.art047 Compliance with the protocol and good clinical practice Regulated
  • Run clinical trials according to protocol and good clinical practiceAny Person
s.art048 Monitoring Regulated
  • Adequately monitor clinical trial conductAny Person
s.art052 Reporting of serious breaches Regulated
  • Report serious breaches in clinical trials within 7 daysEmployer
s.art053 Other reporting obligations relevant for subject safety Regulated
  • Report unexpected events affecting benefit-risk balance and submit third-country inspection reportsAny Person
s.art054 Urgent safety measures Regulated
  • Take urgent safety measures and notify the MHRA within 7 daysEmployer
s.art055 Investigator's brochure Regulated
  • Provide and keep updated the investigator's brochure for clinical trialsAny Person
s.art056 Recording, processing, handling and storage of information Regulated
  • Record and protect clinical trial information and personal dataData Controller
s.art057 Clinical trial master file Regulated
  • Keep a clinical trial master file with essential documentsAny Person
s.art058 Archiving of the clinical trial master file Regulated
  • Archive clinical trial master file for 25 years after trial endAny Person
s.art059 Auxiliary medicinal products Regulated
  • Use only authorised auxiliary medicinal products in clinical trials unless exception appliesAny Person
s.art062 Responsibilities of the qualified person Regulated
  • Ensure qualified person certifies each batch of investigational medicinal product and provide certification to regulatorsAny Person
s.art072 Co-sponsorship Regulated
  • Allocate responsibilities among co-sponsors in a written contractAny Person
s.art074 Legal representative of the sponsor in the Union Regulated
  • Appoint a legal representative in the UK for EU-based clinical trialsAny Person
s.art076 Damage compensation Regulated
  • Ensure compensation insurance is in place and used for clinical trial participantsAny Person
s.art081 EU database Regulated
  • Keep the EU database updated with non-substantial trial changesAny Person
89 other provisions — procedural and definitional
uri:annex/i/division/b/division/7 uri:annex/i/division/b/division/7
uri:annex/i/division/d/division/15 uri:annex/i/division/d/division/15
uri:annex/i/division/d/division/17 uri:annex/i/division/d/division/17
uri:annex/i/division/d/division/20 uri:annex/i/division/d/division/20
uri:annex/i/division/d/division/24 uri:annex/i/division/d/division/24
uri:annex/i/division/e uri:annex/i/division/e
uri:annex/i/division/l/division/61 uri:annex/i/division/l/division/61
uri:annex/ii/division/a/division/1 uri:annex/ii/division/a/division/1
uri:annex/ii/division/f uri:annex/ii/division/f
uri:annex/iii/division/2/division/2.3/division/10 uri:annex/iii/division/2/division/2.3/division/10
uri:annex/iii/division/3 uri:annex/iii/division/3
uri:annex/vi/division/a/division/a.1/division/1 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.2.1/division/4
uri:annex/vi/division/a/division/a.2/division/a.2.2/division/5 uri:annex/vi/division/a/division/a.2/division/a.2.2/division/5
uri:annex/vi/division/d/division/8 uri:annex/vi/division/d/division/8
s.annex iv para.1 The summary of the results of the clinical trial shall...
s.annex v para.1 The summary of the results of the clinical trial for...
s.annex v para.2 Clinical trial identification (including title of the trial, protocol number,...
s.art001 Scope
s.art002 Definitions
s.art003 General principle
s.art004 Prior authorisation
s.art008 Decision on the clinical trial
s.art009 Persons assessing the application
s.art010 Specific considerations for vulnerable populations
s.art011 Submission and assessment of applications limited to aspects covered by Part I or Part II of the assessment report
s.art012 Withdrawal
s.art013 Resubmission
s.art015 General principles
s.art017 Validation of an application for the authorisation of a substantial modification of an aspect covered by Part I of the assessment report
s.art019 Decision on the substantial modification of an aspect covered by Part I of the assessment report
s.art021 Substantial modification of aspects covered by Parts I and II of the assessment report
s.art023 Decision on the substantial modification of aspects covered by Parts I and II of the assessment report
s.art024 Persons assessing the application for a substantial modification
s.art025 Data submitted in the application dossier
s.art026 Language requirements
s.art027 Update by way of delegated acts
s.art028 General rules
s.art029 Informed consent
s.art030 Informed consent in cluster trials
s.art031 Clinical trials on incapacitated subjects
s.art032 Clinical trials on minors
s.art033 Clinical trials on pregnant or breastfeeding women
s.art034 Additional national measures
s.art035 Clinical trials in emergency situations
s.art038 Temporary halt or early termination by the sponsor for reasons of subject safety
s.art039 Update of the contents of the summary of results and summary for laypersons
s.art040 Electronic database for safety reporting
s.art044 Assessment by Member States
s.art045 Technical aspects
s.art046 Reporting with regard to auxiliary medicinal products
s.art049 Suitability of individuals involved in conducting the clinical trial
s.art050 Suitability of clinical trial sites
s.art051 Traceability, storage, return and destruction of investigational medicinal products
s.art060 Scope of this Chapter
s.art061 Authorisation of manufacturing and import
s.art063 Manufacturing and import
s.art064 Modification of authorised investigational medicinal products
s.art065 Manufacturing of auxiliary medicinal products
s.art066 Unauthorised investigational and unauthorised auxiliary medicinal products
s.art067 Authorised investigational and authorised auxiliary medicinal products
s.art068 Radiopharmaceuticals used as investigational medicinal products or as auxiliary medicinal products for a medical diagnosis
s.art069 Language
s.art070 Delegated act
s.art071 Sponsor
s.art073 Principal investigator
s.art075 Liability
s.art077 Corrective measures to be taken by Member States
s.art078 Member State inspections
s.art079 Union controls
s.art080 EU portal
s.art082 Functionality of the EU portal and the EU database
s.art083 National contact points
s.art084 Support by the Agency and the Commission
s.art085 Clinical Trials Coordination and Advisory Group
s.art086 General principle
s.art087 One payment per activity per Member State
s.art088 Committee procedure
s.art089 Exercise of the delegation
s.art090 Specific requirements for special groups of medicinal products
s.art091 Relation with other Union legislation
s.art092 Investigational medicinal products, other products and procedures, free of charge for the subject
s.art093 Data protection
s.art094 Penalties
s.art095 Civil and criminal liability
s.art096 Repeal
s.art097 Review
s.art098 Transitional provision
s.art099 Entry into force

Duty extraction and severity labels are Guvnor’s analysis of the instrument, not the instrument itself. Always verify against the linked source text.