UK Statutory Instrument SI 2004 United Kingdom

Medicines for Human Use (Clinical Trials) Regulations 2004

These Regulations implement Directive 2001/20/EC on the approximation of laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (“the Directive”).

Read it on legislation.gov.uk (opens in a new tab)
Enforced by
MHRA
Status
Amended (in force with amendments)
Penalty ceiling
Imprisonment 4 of 76 obligations carry up to 2 years imprisonment. 72 have no criminal penalty — flagged in the list below.

Does it bind you?

Business-side roles with duties under this instrument.

Manufacturer32 Any Person20 Client11 Applicant5 Trader1

Plus 7 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.

Manufacturer — also bound by 502 other Acts
Any Person — also bound by 2340 other Acts
Client — also bound by 62 other Acts
Applicant — also bound by 307 other Acts
Trader — also bound by 825 other Acts
Companies Act 2006 243 duties
Companies Act 1985 85 duties

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.

Part 1

INTRODUCTORY PROVISIONS

3 of 7 sections shown
s.002 List of countries for the purpose of the definition of “marketing authorization” Regulated
Other duties (1) — Crown / regulator
  • MHRA must maintain and review the list of countries for marketing authorizationsStatutory regulator
s.003 Sponsor’s responsibility for the investigator’s brochure Regulated
  • Maintain and update the Clinical Trial Investigator’s BrochureClient
s.003 Sponsor of a clinical trial (opens in a new tab) Regulated
  • Establish a clinical trial sponsor and assign legal responsibilitiesAny Person
4 other sections in this Part — procedural and definitional
s.001 Citation and commencement
s.002 Interpretation (opens in a new tab)
s.003 Investigator in a clinical trial
s.004 Responsibility for functions under the Directive (opens in a new tab)
Part 2

ETHICS COMMITTEES

0 of 6 sections shown
6 other sections in this Part — procedural and definitional
s.005 United Kingdom Ethics Committees Authority (opens in a new tab)
s.006 Establishment and abolition of ethics committees
s.007 Recognition of ethics committees (opens in a new tab)
s.008 Revocation of recognition (opens in a new tab)
s.009 Constitution and operation of ethics committees (opens in a new tab)
s.010 Other functions of the Authority (opens in a new tab)
Part 3

AUTHORISATION FOR CLINICAL TRIALS AND ETHICS COMMITTEE OPINION

6 of 27 sections shown
s.013 Supply of investigational medicinal products for the purpose of clinical trials (opens in a new tab) Regulated
  • Only supply clinical trial medicines with required authorisationsTrader
s.014 Application for ethics committee opinion (opens in a new tab) Regulated
  • Apply for an ethics committee opinion for a clinical trialAny Person
s.017 Request for authorisation to conduct a clinical trial (opens in a new tab) Regulated
  • Apply for authorisation to conduct a clinical trialClient
s.024 Amendments by the sponsor (opens in a new tab) Regulated
  • Notify MHRA and Ethics Committees of changes to clinical trialsClient
s.025 Modifying or adapting rejected proposals for amendment (opens in a new tab) Regulated
  • Notify authorities 14 days before making modified protocol amendmentsClient
s.027 Conclusion of clinical trial (opens in a new tab) Regulated
  • Notify the MHRA and Ethics Committee when a clinical trial endsClient
21 other sections in this Part — procedural and definitional
s.011 Interpretation of Part 3
s.011 Definition of notifiable trial
s.011 Definition of Route B substantial modification
s.012 Requirement for authorisation and ethics committee opinion
s.015 Ethics committee opinion (opens in a new tab)
s.016 Review and appeal relating to ethics committee opinion (opens in a new tab)
s.018 Request for further information regarding a request for approval
s.018 Approval procedure for amended requests for approval
s.018 Approval procedure time periods in special circumstances
s.018 Authorisation procedure for clinical trials involving general medicinal products (opens in a new tab)
s.019 Authorisation procedure for clinical trials involving medicinal products for gene therapy etc. (opens in a new tab)
s.020 Authorisation procedure for clinical trials involving medicinal products with special characteristics (opens in a new tab)
s.021 Clinical trials conducted in countries other than the United Kingdom (opens in a new tab)
s.022 Approval procedure for substantial modifications
s.022 Request for further information regarding proposed substantial modifications
s.022 Approval procedure for amended requests regarding substantial modifications
s.022 Amendments to clinical trial authorisation (opens in a new tab)
s.023 Amendments by the licensing authority (opens in a new tab)
s.026 Reference to the appropriate committee or the Medicines Commission (opens in a new tab)
s.information sharing Information sharing
s.publication of information Publication of information
Part 4

GOOD CLINICAL PRACTICE AND THE CONDUCT OF CLINICAL TRIALS

5 of 6 sections shown
s.028 Good clinical practice and protection of clinical trial subjects (opens in a new tab) Regulated
  • Adhere to good clinical practice and provide trial medicines free of chargeClient
s.029 Notification of serious breaches Regulated
  • Notify MHRA of serious breaches in clinical trialsClient
s.029 Conduct of trial in accordance with clinical trial authorisation etc. (opens in a new tab) Imprisonment
  • Conduct clinical trials in strict accordance with approved documentsAny Person
s.030 Urgent safety measures (opens in a new tab) Regulated
  • Notify the MHRA and Ethics Committee of urgent safety measuresClient
s.031 Trial master file and archiving Regulated
  • Maintain and archive a trial master file for clinical trialsClient
1 other section in this Part — procedural and definitional
s.031 Suspension or termination of clinical trial (opens in a new tab)
Part 5

PHARMACOVIGILANCE

4 of 5 sections shown
s.032 Notification of adverse events (opens in a new tab) Regulated
  • Report serious adverse events during clinical trialsAny Person
s.033 Notification of suspected unexpected serious adverse reactions (opens in a new tab) Regulated
  • Report suspected unexpected serious adverse reactions (SUSARs)Client
s.034 Clinical trials conducted in countries other than the United Kingdom (opens in a new tab) Regulated
  • Report serious adverse reactions from international clinical trial sitesAny Person
s.035 Annual list of suspected serious adverse reactions and safety report (opens in a new tab) Regulated
  • Submit annual safety report and list of serious adverse reactions for clinical trialsAny Person
1 other section in this Part — procedural and definitional
s.reg.a32 Record keeping
Part 6

MANUFACTURE AND IMPORTATION OF INVESTIGATIONAL MEDICINAL PRODUCTS

6 of 16 sections shown
s.038 Application for manufacturing authorisation (opens in a new tab) Regulated
  • Apply for a manufacturing authorisation for clinical trial medicinesApplicant
s.039 Consideration of application for manufacturing authorisation (opens in a new tab) Regulated
Other duties (1) — Crown / regulator
  • Licensing authority must decide manufacturing authorisation within 90 daysStatutory regulator
s.040 Grant or refusal of manufacturing authorisation (opens in a new tab) Regulated
Other duties (1) — Crown / regulator
  • Licensing authority must grant or refuse manufacturing authorisationsStatutory regulator
s.042 Obligations of manufacturing authorisation holder (opens in a new tab) Regulated
  • Comply with Good Manufacturing Practice and support the Qualified PersonManufacturer
s.043 Approved country for import Regulated
Other duties (1) — Crown / regulator
  • MHRA must maintain and review the list of approved countries for importStatutory regulator
s.043 Qualified persons (opens in a new tab) Regulated
  • Have a qualified person oversee batch certification for clinical trial medicinesManufacturer
10 other sections in this Part — procedural and definitional
s.036 Requirement for authorisation to manufacture or import investigational medicinal products (opens in a new tab)
s.037 Exemption for radiopharmaceuticals used for diagnostic purposes
s.037 Exemption for hospitals and health centres (opens in a new tab)
s.041 Application and effect of manufacturing authorisation (opens in a new tab)
s.044 Variation of manufacturing authorisation (opens in a new tab)
s.045 Suspension and revocation of manufacturing authorisation (opens in a new tab)
s.manufacture of mm investigational medicinal produc Manufacture of MM investigational medicinal products
s.manufacture of poc investigational medicinal produ Manufacture of POC investigational medicinal products
s.variation of mm (imp) master file Variation of MM (IMP) master file
s.variation of poc (imp) master file Variation of POC (IMP) master file
Part 6

NON-INVESTIGATIONAL MEDICINAL AND NON-MEDICINAL PRODUCTS

0 of 1 section shown
1 other section in this Part — procedural and definitional
s.045 Non-investigational medicinal and non-medicinal products
Part 7

LABELLING

0 of 3 sections shown
3 other sections in this Part — procedural and definitional
s.046 Labelling of non-investigational medicinal products
s.046 Labelling of certain POC investigational medicinal products
s.046 Labelling (opens in a new tab)
Part 8

ENFORCEMENT AND RELATED PROVISIONS

3 of 6 sections shown
s.049 Offences (opens in a new tab) Imprisonment
  • Breach listed clinical‑trial regulationsAny Person
s.050 False or misleading information (opens in a new tab) Imprisonment
  • Provide false or misleading information in clinical trial applicationsAny Person
s.052 Penalties (opens in a new tab) Imprisonment
  • Breach of clinical trial regulationsAny Person
3 other sections in this Part — procedural and definitional
s.047 Application of enforcement provisions of the 2012 Regulations (opens in a new tab)
s.048 Infringement notices (opens in a new tab)
s.051 Defence of due diligence (opens in a new tab)
Part 9

MISCELLANEOUS PROVISIONS

0 of 6 sections shown
6 other sections in this Part — procedural and definitional
s.053 Construction of references to specified publications (opens in a new tab)
s.054 Consequential and other amendments to enactments (opens in a new tab)
s.055 Revocations (opens in a new tab)
s.056 Transitional provisions (opens in a new tab)
s.057 Functions in relation to good clinical practice (opens in a new tab)
s.058 Detailed guidance (opens in a new tab)
Schedules

Schedules

38 of 110 shown
s.006 PARTICULARS THAT MUST ACCOMPANY AN APPLICATION FOR A MANUFACTURING AUTHORISATION (opens in a new tab) Regulated
  • Submit required details when applying for a manufacturing authorisationApplicant
s.sch001 Clinical trials must be conducted in accordance with the principles... Regulated
  • Conduct clinical trials in accordance with Good Clinical Practice (ICH GCP)Any Person
s.sch001 Except where it would be a contravention of these Regulations,... Regulated
  • Run clinical trials in line with Declaration of HelsinkiAny Person
s.sch001 The investigator and sponsor must have regard to all relevant... Regulated
  • Consider all relevant guidance when starting and running a clinical trialAny Person
s.sch001 Provision must be made for insurance or indemnity to cover... Regulated
  • Arrange insurance or indemnity to cover all clinical trial liabilitiesAny Person
s.sch005 Hearing before the appropriate committee Regulated
  • Submit representations and documents to the MHRA committee within the deadlineAny Person
s.sch005 Hearing before person appointed Regulated
  • Provide written representations and documents within 3 months when requesting a hearingAny Person
s.sch006 Where the application relates to an MM investigational medicinal product,... Regulated
  • Submit a detailed dossier with your MM investigational medicinal product applicationManufacturer
s.sch006 Where the application relates to a POC investigational medicinal product,... Regulated
  • Submit POC IMP dossier: sites, processes, quality contactsApplicant
s.sch006 Where the application relates to the inactivation of viral or... Regulated
  • Provide manufacturing process statement for viral inactivation applicationsApplicant
s.sch006 A description of the arrangements at each of the premises... Regulated
  • Maintain proper stock turnover records for investigational medicinesAny Person
s.sch007 The holder of the authorisation shall ensure that any tests... Regulated
  • Test investigational or EAMS medicinal products after manufactureManufacturer
s.sch007 Where the authorisation relates to the assembly of an investigational... Regulated
  • Supply incomplete labelling details with partially assembled medicinesManufacturer
s.sch007 Where— (a) the manufacturing authorisation relates to the assembly of... Regulated
  • Notify MHRA of any changes to your outsourced manufacturerManufacturer
s.sch007 The holder of the authorisation, for the purpose of enabling... Regulated
  • Allow MHRA inspections and provide all necessary facilitiesManufacturer
s.sch007 The holder of the authorisation shall at all times provide... Regulated
  • Provide and maintain resources for qualified person dutiesManufacturer
s.sch007 The holder of the authorisation shall only manufacture or assemble... Regulated
  • Only manufacture EAMS products as needed for the schemeManufacturer
s.sch007 The holder of the authorisation shall maintain and make available... Regulated
  • Maintain a master file for each MM investigational medicinal productManufacturer
s.sch007 An MM (IMP) master file shall contain, as a minimum,... Regulated
  • Keep MM (IMP) master file with required manufacturing/assembly detailsManufacturer
s.sch007 The holder of the authorisation shall ensure that the information... Regulated
  • Keep MM (IMP) master file information up to dateManufacturer
s.sch007 The holder of the authorisation shall submit to the licensing... Regulated
  • Send annual updates of MM (IMP) master file changes to MHRAManufacturer
s.sch007 The holder of the authorisation shall conduct regular reviews of... Regulated
  • Conduct regular reviews of supervision and control at each modular unitManufacturer
s.sch007 The holder of a manufacturing authorisation (MM) shall ensure that—... Regulated
  • Comply with modular manufacturing rules in your MM authorisationManufacturer
s.sch007 The holder of the authorisation shall maintain and make available... Regulated
  • Maintain a POC (IMP) master file for each product and make available to MHRAManufacturer
s.sch007 A POC (IMP) master file shall contain, as a minimum,... Regulated
  • Maintain POC (IMP) master file with manufacturing site detailsManufacturer
s.sch007 The holder of the authorisation shall ensure that the information... Regulated
  • Keep your POC (IMP) master file information up to dateManufacturer
s.sch007 The holder of the authorisation shall submit to the licensing... Regulated
  • Submit annual updates to MHRA for POC (IMP) master file changesManufacturer
s.sch007 The holder of the authorisation shall conduct regular reviews of... Regulated
  • Regularly review supervision and manufacturing controls at each authorised siteManufacturer
s.sch007 The holder of a manufacturing authorisation (POC) shall ensure that—... Regulated
  • Manufacture only authorised POC medicines at specified sitesManufacturer
s.sch007 The holder of a manufacturing authorisation (MM) shall not use... Regulated
  • Use only listed manufacturing premisesManufacturer
s.sch007 The holder of a manufacturing authorisation (POC) shall not use... Regulated
  • Use only approved premises for specified activitiesManufacturer
s.sch007 The holder of the authorisation shall inform the licensing authority... Regulated
  • Notify MHRA before making material alterations to IMP control site premises or operationsManufacturer
s.sch007 The holder of the authorisation shall inform the licensing authority... Regulated
  • Notify MHRA before altering premises, plant or operations at POC control siteManufacturer
s.sch007 The holder of the authorisation shall only import EAMS medicinal... Regulated
  • Only import EAMS medicinal products when needed for the schemeManufacturer
s.sch008 (1) If the applicant or holder gives notice under paragraph... Regulated
  • Provide written summary and documents before the hearingApplicant
s.sch013 List of countries for the purpose of the definition of “marketing authorization” on IP completion day (regulation 2A) Regulated
Other duties (1) — Crown / regulator
  • MHRA must keep EEA states on the marketing authorisation list during the 2-year transitionStatutory regulator
s.sch013 List of countries where a sponsor of a clinical trial, or their legal representative, may be established on IP completion day (regulation 3(11A)) Regulated
Other duties (1) — Crown / regulator
  • MHRA must keep EEA States on sponsor establishment list for 2 yearsStatutory regulator
s.sch013 Approved country for import list on IP completion day (regulation 43A) Regulated
Other duties (1) — Crown / regulator
  • MHRA must keep EEA States on the approved country list for importsStatutory regulator
72 other schedules
s.001 CONDITIONS AND PRINCIPLES OF GOOD CLINICAL PRACTICE AND FOR THE PROTECTION OF CLINICAL TRIAL SUBJECTS (opens in a new tab)
s.011 REVOCATIONS (opens in a new tab)
s.012 TRANSITIONAL PROVISIONS (opens in a new tab)
s.sch002 In this Schedule— “appointing authority” means— in relation to an...
s.sch002 Expenses
s.sch002 The appointing authority may pay to members of ethics committees...
s.sch002 (1) Within the period six months from the end of...
s.sch002 (1) This paragraph applies where— (a) recognition of an ethics...
s.sch002 (1) The provisions of this Schedule shall not apply in...
s.sch002 Membership
s.sch002 A member of an ethics committee shall hold and vacate...
s.sch002 (1) The appointing authority shall appoint— (a) one of the...
s.sch002 (1) An ethics committee may— (a) appoint sub-committees consisting of...
s.sch002 Deputies and co-opted members
s.sch002 (1) At any meeting of an ethics committee, the committee...
s.sch002 (1) The appointing authority shall make arrangements for the appointment...
s.sch003 The protocol for the proposed trial.
s.sch003 (1) Subject to sub-paragraph (7), a dossier on each investigational...
s.sch003 A description or sample of the labelling which is to...
s.sch003 The name and address of the person responsible for the...
s.sch003 (1) The address of any premises at which any batch...
s.sch003 A description of the proposed clinical trial.
s.sch004 (1) Subject to the following sub-paragraphs, where the United Kingdom...
s.sch004 Where a direction is given in accordance with paragraph 1(1)(a)—...
s.sch004 (1) An appeal panel appointed pursuant to paragraph 1(1)(b) shall...
s.sch004 (1) An appeal panel shall consider an ethics committee opinion...
s.sch004 If an appeal panel gives a favourable opinion, the condition...
s.sch004 The Authority may pay to members of an appeal panel...
s.sch005 Licensing authority decision
s.sch005 Right to be heard by a person appointed
s.sch006 The name and address of the applicant, and, where the...
s.sch006 A statement describing the types of investigational medicinal product in...
s.sch006 A statement of the manufacturing, assembling or importation operations to...
s.sch006 (1) Except where the application relates to an MM investigational...
s.sch006 A statement of any manufacturing operations, other than those to...
s.sch006 (1) The name and address and qualifications and experience of...
s.sch006 A description of the arrangements for the identification and storage...
s.sch006 A description of the arrangements— (a) for maintaining production or...
s.sch007 The provisions of paragraphs 14C to 14I are incorporated as...
s.sch007 Each master file may relate to one MM investigational medicinal...
s.sch007 The provisions of paragraphs 14K to 14Q are incorporated as...
s.sch007 Each master file may relate to one POC investigational medicinal...
s.sch008 In this Schedule— “authorisation” means a manufacturing authorisation; and “time...
s.sch008 Subject to paragraph 6, if the licensing authority propose—
s.sch008 Any notification given under paragraph 2 shall include a statement...
s.sch008 (1) Subject to sub-paragraph (2), the applicant or holder to...
s.sch008 (1) Paragraph 2 shall not apply to the suspension of...
s.sch009 The modifications of the 2012 Regulations mentioned in regulation 47...
s.sch009 In regulation 2 (medicinal products)— (a) at the beginning of...
s.sch009 In regulation 8(1) (interpretation)— (a) the definition “assemble” is substituted...
s.sch009 In regulation 322(1) (validity of decisions and proceedings) omit “or”...
s.sch009 In regulation 325(1) (rights of entry) insert after sub-paragraph (b)...
s.sch009 (1) Regulation 327 (powers of inspection, sampling and seizure) is...
s.sch010 In section 132 of the Act (general interpretation provisions)—
s.sch010 In section 1 of the Medicines Act 1971 (fees payable...
s.sch010 Section 51 of the Adults with Incapacity (Scotland) Act 2000...
s.sch012 (1) This sub-paragraph applies where— (a) a clinical trial is...
s.sch012 (1) This sub-paragraph applies where a person has made an...
s.sch012 Clinical trial exemptions or notifications prior to 1st May 2004
s.sch012 (1) This sub-paragraph applies where— (a) a clinical trial is...
s.sch012 (1) This sub-paragraph applies where— (a) a clinical trial is...
s.sch012 (1) This sub-paragraph applies where— (a) a clinical trial is...
s.sch012 (1) This sub-paragraph applies where— (a) an application for a...
s.sch013 Import of investigational medicinal products into Great Britain from EEA States during the transitional period
s.sch014 Interpretation
s.sch014 Application of the old rules to the authorisation etc of existing clinical trials
s.sch014 Application of Good Clinical Practice to old rules clinical trials
s.sch014 Pharmacovigilance in respect of old rules clinical trials
s.sch014 Manufacture and importation of investigational medicinal products used in old rules clinical trials
s.sch014 Labelling of investigational medicinal products used in old rules clinical trials
s.sch014 Enforcement etc
s.schedule/7/part/1/paragraph/wrapper1n2 In this Schedule— “ Commission Delegated Regulation 2017/1569 ”, in...
sch. 1 para. 14 sch. 1 para. 14 Regulated
  • Design clinical trials for minors to minimise pain and riskAny Person
sch. 1 para. 7 sch. 1 para. 7 Regulated
  • Consider capable minors' wishes to refuse or withdraw from clinical trialsAny Person
sch. 7 para. 1 sch. 7 para. 1 Regulated
  • Provide and maintain staff, premises and equipment for clinical trial product manufactureManufacturer
sch. 7 para. 2 sch. 7 para. 2 Regulated
  • Maintain quality of trial medicines with adequate staff, premises and recordsManufacturer
sch. 7 para. 3 sch. 7 para. 3 Regulated
  • Place quality control system under the responsible personAny Person
sch. 7 para. 4 sch. 7 para. 4 Regulated
  • Notify MHRA before changing premises or your qualified personClient
sch. 7 para. 5 sch. 7 para. 5 Regulated
  • Provide information about manufactured medicines to the MHRA on requestManufacturer
sch. 7 para. 6 sch. 7 para. 6 Regulated
  • Notify MHRA before making material changes to premises, operations or key personnelManufacturer
sch. 7 para. 7 sch. 7 para. 7 Regulated
  • Keep batch documentation available for MHRA inspectionManufacturer
sch. 7 para. 8 sch. 7 para. 8 Regulated
  • Keep batch samples of bulk formulated products available for MHRA inspectionManufacturer
sch. 7 para. 9 sch. 7 para. 9 Regulated
  • Withhold non-conforming medicine batches when MHRA directsAny Person
13 other provisions
sch. 1 para. 13 Principles
sch. 1 para. 15 sch. 1 para. 15
sch. 1 para. 16 sch. 1 para. 16
sch. 1 para. 5 sch. 1 para. 5
sch. 1 para. 8 sch. 1 para. 8
sch. 3 para. 1 sch. 3 para. 1
sch. 3 para. 3 sch. 3 para. 3
sch. 3 para. 4 sch. 3 para. 4
sch. 3 para. 5 sch. 3 para. 5
s.001 (1) The conditions and principles specified in Part 2 apply... (opens in a new tab)
s.006 The minor has received information according to his capacity of... (opens in a new tab)
s.011 The clinical trial is necessary to validate data obtained— (opens in a new tab)
s.012 The corresponding scientific guidelines of the European Medicines Agency are... (opens in a new tab)

Help complying

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Run a healthcare business

Ongoing compliance for CQC-registered healthcare providers covering inspections, professional registration, safeguarding, clinical governance, medicines management, and staff obligations

Running clinical trials in the UK

How to get MHRA authorisation for clinical trials of investigational medicinal products (CTIMPs). Covers combined review process, GCP requirements, safety reporting, informed …
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MHRA licensing for medicines and medical devices

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