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UK Statutory Instrument
2004
United Kingdom
Medicines for Human Use (Clinical Trials) Regulations 2004
At a glance
Enforced by
What's here
60 compliance obligations, 2 practical guides · 1 journey
Penalty landscape
4 of 60 obligations carry up to 2 years imprisonment. 56 have no criminal penalty — flagged in the list below.
Who this Act binds
Business-side actors with duties under this Act, ranked by how often they appear.
- Manufacturer 24
- Any Person 15
- Client 11
- Applicant 3
Plus 7 non-business duties on Crown ministers, regulators, local authorities or tribunals — shown collapsed under each section below.
Step-by-step journeys using this legislation
Walkthroughs that take you from a real business situation to compliance.
Relevant guidance
Practical guides for businesses affected by this Act, ordered by how closely they engage with it.
Direct — cites this Act
1 guidesMentioned in related content
1 guidesOther Acts binding the same actors
For each actor bound by this Act, the other UK Acts that bind them most often. Useful for understanding the full compliance landscape facing each role.
Manufacturers also bound by 472 other Acts (top 5 shown)
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- Non-Automatic Weighing Instruments Regulations 2016 2016 67 duties
- Pyrotechnic Articles (Safety) Regulations 2015 2015 64 duties
Any Person also bound by 2338 other Acts (top 5 shown)
- Human Medicines Regulations 2012 2012 169 duties
- Merchant Shipping Act 1995 1995 144 duties
- Insolvency (England and Wales) Rules 2016 2016 101 duties
- Road Traffic Act 1988 1988 95 duties
- Air Navigation Order 2016 2016 95 duties
Clients also bound by 65 other Acts (top 5 shown)
- Construction (Design and Management) Regulations 2015 2015 32 duties
- The Building (Higher-Risk Buildings Procedures) (Wales) Regulations 2025 2025 19 duties
- Building (Higher-Risk Buildings Procedures) (England) Regulations 2023 2023 17 duties
- Building Regulations (Northern Ireland) 2012 2012 14 duties
- Building Regulations 2010 2010 12 duties
Applicants also bound by 294 other Acts (top 5 shown)
- Insolvency (England and Wales) Rules 2016 2016 46 duties
- Human Medicines Regulations 2012 2012 30 duties
- The Land Registration Rules 2003 2003 25 duties
- Value Added Tax Regulations 1995 1995 18 duties
- Space Industry Regulations 2021 2021 14 duties
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.
Part 1 — INTRODUCTORY PROVISIONS
List of countries for the purpose of the definition of “marketing authorization”
Other duties (1) — Crown / regulator
- MHRA must maintain and review the list of countries for marketing authorizations Statutory regulator
Sponsor’s responsibility for the investigator’s brochure
- Maintain and update the Clinical Trial Investigator’s Brochure Client
Sponsor of a clinical trial
- Establish a clinical trial sponsor and assign legal responsibilities Any Person
Browse 4 other sections in this Part — procedural / definitional / commencement
Citation and commencement
Interpretation
Investigator in a clinical trial
Responsibility for functions under the Directive
Part 2 — ETHICS COMMITTEES
Browse 6 other sections in this Part — procedural / definitional / commencement
United Kingdom Ethics Committees Authority
Establishment and abolition of ethics committees
Recognition of ethics committees
Revocation of recognition
Constitution and operation of ethics committees
Other functions of the Authority
Part 3 — AUTHORISATION FOR CLINICAL TRIALS AND ETHICS COMMITTEE OPINION
Application for ethics committee opinion
- Apply for an ethics committee opinion for a clinical trial Any Person
Request for authorisation to conduct a clinical trial
- Apply for authorisation to conduct a clinical trial Client
Amendments by the sponsor
- Notify MHRA and Ethics Committees of changes to clinical trials Client
Modifying or adapting rejected proposals for amendment
- Notify authorities 14 days before making modified protocol amendments Client
Conclusion of clinical trial
- Notify the MHRA and Ethics Committee when a clinical trial ends Client
Browse 22 other sections in this Part — procedural / definitional / commencement
Interpretation of Part 3
Definition of notifiable trial
Definition of Route B substantial modification
Requirement for authorisation and ethics committee opinion
Supply of investigational medicinal products for the purpose of clinical trials
Ethics committee opinion
Review and appeal relating to ethics committee opinion
Request for further information regarding a request for approval
Approval procedure for amended requests for approval
Approval procedure time periods in special circumstances
Authorisation procedure for clinical trials involving general medicinal products
Authorisation procedure for clinical trials involving medicinal products for gene therapy etc.
Authorisation procedure for clinical trials involving medicinal products with special characteristics
Clinical trials conducted in countries other than the United Kingdom
Approval procedure for substantial modifications
Request for further information regarding proposed substantial modifications
Approval procedure for amended requests regarding substantial modifications
Amendments to clinical trial authorisation
Amendments by the licensing authority
Reference to the appropriate committee or the Medicines Commission
Information sharing
Publication of information
Part 4 — GOOD CLINICAL PRACTICE AND THE CONDUCT OF CLINICAL TRIALS
Good clinical practice and protection of clinical trial subjects
- Adhere to good clinical practice and provide trial medicines free of charge Client
Notification of serious breaches
- Notify MHRA of serious breaches in clinical trials Client
Conduct of trial in accordance with clinical trial authorisation etc.
2 years imprisonment- Conduct clinical trials in strict accordance with approved documents Any Person
Urgent safety measures
- Notify the MHRA and Ethics Committee of urgent safety measures Client
Trial master file and archiving
- Maintain and archive a trial master file for clinical trials Client
Browse 1 other section in this Part — procedural / definitional / commencement
Part 5 — PHARMACOVIGILANCE
Notification of adverse events
- Report serious adverse events during clinical trials Any Person
Notification of suspected unexpected serious adverse reactions
- Report suspected unexpected serious adverse reactions (SUSARs) Client
Clinical trials conducted in countries other than the United Kingdom
- Report serious adverse reactions from international clinical trial sites Any Person
Annual list of suspected serious adverse reactions and safety report
- Submit annual safety report and list of serious adverse reactions for clinical trials Any Person
Browse 1 other section in this Part — procedural / definitional / commencement
Record keeping
Part 6 — MANUFACTURE AND IMPORTATION OF INVESTIGATIONAL MEDICINAL PRODUCTS
Application for manufacturing authorisation
- Apply for a manufacturing authorisation for clinical trial medicines Applicant
Consideration of application for manufacturing authorisation
Other duties (1) — Crown / regulator
- Licensing authority must decide manufacturing authorisation within 90 days Statutory regulator
Grant or refusal of manufacturing authorisation
Other duties (1) — Crown / regulator
- Licensing authority must grant or refuse manufacturing authorisations Statutory regulator
Obligations of manufacturing authorisation holder
- Comply with Good Manufacturing Practice and support the Qualified Person Manufacturer
Approved country for import
Other duties (1) — Crown / regulator
- MHRA must maintain and review the list of approved countries for import Statutory regulator
Qualified persons
- Have a qualified person oversee batch certification for clinical trial medicines Manufacturer
Browse 10 other sections in this Part — procedural / definitional / commencement
Requirement for authorisation to manufacture or import investigational medicinal products
Exemption for radiopharmaceuticals used for diagnostic purposes
Exemption for hospitals and health centres
Application and effect of manufacturing authorisation
Variation of manufacturing authorisation
Suspension and revocation of manufacturing authorisation
Manufacture of MM investigational medicinal products
Manufacture of POC investigational medicinal products
Variation of MM (IMP) master file
Variation of POC (IMP) master file
Part 6A — NON-INVESTIGATIONAL MEDICINAL AND NON-MEDICINAL PRODUCTS
Browse 1 other section in this Part — procedural / definitional / commencement
Non-investigational medicinal and non-medicinal products
Part 7 — LABELLING
Browse 3 other sections in this Part — procedural / definitional / commencement
Labelling of non-investigational medicinal products
Labelling of certain POC investigational medicinal products
Labelling
Part 8 — ENFORCEMENT AND RELATED PROVISIONS
Offences
2 years imprisonment- Breach listed clinical‑trial regulations Any Person
False or misleading information
2 years imprisonment- Provide false or misleading information in clinical trial applications Any Person
Penalties
2 years imprisonment- Breach of clinical trial regulations Any Person
Browse 3 other sections in this Part — procedural / definitional / commencement
Part 9 — MISCELLANEOUS PROVISIONS
Browse 6 other sections in this Part — procedural / definitional / commencement
Schedules
PARTICULARS THAT MUST ACCOMPANY AN APPLICATION FOR A MANUFACTURING AUTHORISATION
- Submit required details when applying for a manufacturing authorisation Applicant
Clinical trials must be conducted in accordance with the principles...
- Conduct clinical trials in accordance with Good Clinical Practice (ICH GCP) Any Person
Provision must be made for insurance or indemnity to cover...
- Arrange insurance or indemnity to cover all clinical trial liabilities Any Person
Hearing before the appropriate committee
- Submit representations and documents to the MHRA committee within the deadline Any Person
Hearing before person appointed
- Provide written representations and documents within 3 months when requesting a hearing Any Person
A description of the arrangements at each of the premises...
- Maintain proper stock turnover records for investigational medicines Any Person
The holder of the authorisation shall ensure that any tests...
- Test investigational or EAMS medicinal products after manufacture Manufacturer
Where the authorisation relates to the assembly of an investigational...
- Supply incomplete labelling details with partially assembled medicines Manufacturer
Where— (a) the manufacturing authorisation relates to the assembly of...
- Notify MHRA of any changes to your outsourced manufacturer Manufacturer
The holder of the authorisation, for the purpose of enabling...
- Allow MHRA inspections and provide all necessary facilities Manufacturer
The holder of the authorisation shall at all times provide...
- Provide and maintain resources for qualified person duties Manufacturer
The holder of the authorisation shall only manufacture or assemble...
- Only manufacture EAMS products as needed for the scheme Manufacturer
The holder of the authorisation shall maintain and make available...
- Maintain a master file for each MM investigational medicinal product Manufacturer
The holder of the authorisation shall ensure that the information...
- Keep MM (IMP) master file information up to date Manufacturer
The holder of the authorisation shall conduct regular reviews of...
- Conduct regular reviews of supervision and control at each modular unit Manufacturer
The holder of a manufacturing authorisation (MM) shall ensure that—...
- Comply with modular manufacturing rules in your MM authorisation Manufacturer
The holder of the authorisation shall maintain and make available...
- Maintain a POC (IMP) master file for each product and make available to MHRA Manufacturer
The holder of the authorisation shall ensure that the information...
- Keep your POC (IMP) master file information up to date Manufacturer
The holder of a manufacturing authorisation (POC) shall ensure that—...
- Manufacture only authorised POC medicines at specified sites Manufacturer
The holder of the authorisation shall inform the licensing authority...
- Notify MHRA before making material alterations to IMP control site premises or operations Manufacturer
The holder of the authorisation shall inform the licensing authority...
- Notify MHRA before altering premises, plant or operations at POC control site Manufacturer
The holder of the authorisation shall only import EAMS medicinal...
- Only import EAMS medicinal products when needed for the scheme Manufacturer
(1) If the applicant or holder gives notice under paragraph...
- Provide written summary and documents before the hearing Applicant
List of countries for the purpose of the definition of “marketing authorization” on IP completion day (regulation 2A)
Other duties (1) — Crown / regulator
- MHRA must keep EEA states on the marketing authorisation list during the 2-year transition Statutory regulator
List of countries where a sponsor of a clinical trial, or their legal representative, may be established on IP completion day (regulation 3(11A))
Other duties (1) — Crown / regulator
- MHRA must keep EEA States on sponsor establishment list for 2 years Statutory regulator
Approved country for import list on IP completion day (regulation 43A)
Other duties (1) — Crown / regulator
- MHRA must keep EEA States on the approved country list for imports Statutory regulator
Browse 84 other Schedules — structural / supplementary
CONDITIONS AND PRINCIPLES OF GOOD CLINICAL PRACTICE AND FOR THE PROTECTION OF CLINICAL TRIAL SUBJECTS
REVOCATIONS
TRANSITIONAL PROVISIONS
Except where it would be a contravention of these Regulations,...
The investigator and sponsor must have regard to all relevant...
In this Schedule— “appointing authority” means— in relation to an...
Expenses
The appointing authority may pay to members of ethics committees...
(1) Within the period six months from the end of...
(1) This paragraph applies where— (a) recognition of an ethics...
(1) The provisions of this Schedule shall not apply in...
Membership
A member of an ethics committee shall hold and vacate...
(1) The appointing authority shall appoint— (a) one of the...
(1) An ethics committee may— (a) appoint sub-committees consisting of...
Deputies and co-opted members
(1) At any meeting of an ethics committee, the committee...
(1) The appointing authority shall make arrangements for the appointment...
The protocol for the proposed trial.
(1) Subject to sub-paragraph (7), a dossier on each investigational...
A description or sample of the labelling which is to...
The name and address of the person responsible for the...
(1) The address of any premises at which any batch...
A description of the proposed clinical trial.
(1) Subject to the following sub-paragraphs, where the United Kingdom...
Where a direction is given in accordance with paragraph 1(1)(a)—...
(1) An appeal panel appointed pursuant to paragraph 1(1)(b) shall...
(1) An appeal panel shall consider an ethics committee opinion...
If an appeal panel gives a favourable opinion, the condition...
The Authority may pay to members of an appeal panel...
Licensing authority decision
Right to be heard by a person appointed
The name and address of the applicant, and, where the...
Where the application relates to an MM investigational medicinal product,...
Where the application relates to a POC investigational medicinal product,...
A statement describing the types of investigational medicinal product in...
A statement of the manufacturing, assembling or importation operations to...
Where the application relates to the inactivation of viral or...
(1) Except where the application relates to an MM investigational...
A statement of any manufacturing operations, other than those to...
(1) The name and address and qualifications and experience of...
A description of the arrangements for the identification and storage...
A description of the arrangements— (a) for maintaining production or...
The provisions of paragraphs 14C to 14I are incorporated as...
Each master file may relate to one MM investigational medicinal...
An MM (IMP) master file shall contain, as a minimum,...
The holder of the authorisation shall submit to the licensing...
The provisions of paragraphs 14K to 14Q are incorporated as...
Each master file may relate to one POC investigational medicinal...
A POC (IMP) master file shall contain, as a minimum,...
The holder of the authorisation shall submit to the licensing...
The holder of the authorisation shall conduct regular reviews of...
The holder of a manufacturing authorisation (MM) shall not use...
The holder of a manufacturing authorisation (POC) shall not use...
In this Schedule— “authorisation” means a manufacturing authorisation; and “time...
Subject to paragraph 6, if the licensing authority propose—
Any notification given under paragraph 2 shall include a statement...
(1) Subject to sub-paragraph (2), the applicant or holder to...
(1) Paragraph 2 shall not apply to the suspension of...
The modifications of the 2012 Regulations mentioned in regulation 47...
In regulation 2 (medicinal products)— (a) at the beginning of...
In regulation 8(1) (interpretation)— (a) the definition “assemble” is substituted...
In regulation 322(1) (validity of decisions and proceedings) omit “or”...
In regulation 325(1) (rights of entry) insert after sub-paragraph (b)...
(1) Regulation 327 (powers of inspection, sampling and seizure) is...
In section 132 of the Act (general interpretation provisions)—
In section 1 of the Medicines Act 1971 (fees payable...
Section 51 of the Adults with Incapacity (Scotland) Act 2000...
(1) This sub-paragraph applies where— (a) a clinical trial is...
(1) This sub-paragraph applies where a person has made an...
Clinical trial exemptions or notifications prior to 1st May 2004
(1) This sub-paragraph applies where— (a) a clinical trial is...
(1) This sub-paragraph applies where— (a) a clinical trial is...
(1) This sub-paragraph applies where— (a) a clinical trial is...
(1) This sub-paragraph applies where— (a) an application for a...
Import of investigational medicinal products into Great Britain from EEA States during the transitional period
Interpretation
Application of the old rules to the authorisation etc of existing clinical trials
Application of Good Clinical Practice to old rules clinical trials
Pharmacovigilance in respect of old rules clinical trials
Manufacture and importation of investigational medicinal products used in old rules clinical trials
Labelling of investigational medicinal products used in old rules clinical trials
Enforcement etc
In this Schedule— “ Commission Delegated Regulation 2017/1569 ”, in...
Other sections — not classified into a Part
These sections sit outside the numbered Parts — usually provisions added or moved by later amendments.
sch. 7 para. 1
- Provide and maintain staff, premises and equipment for clinical trial product manufacture Manufacturer
sch. 7 para. 2
- Maintain quality of trial medicines with adequate staff, premises and records Manufacturer
sch. 7 para. 3
- Place quality control system under the responsible person Any Person
sch. 7 para. 4
- Notify MHRA before changing premises or your qualified person Client
sch. 7 para. 5
- Provide information about manufactured medicines to the MHRA on request Manufacturer
sch. 7 para. 6
- Notify MHRA before making material changes to premises, operations or key personnel Manufacturer
sch. 7 para. 7
- Keep batch documentation available for MHRA inspection Manufacturer
sch. 7 para. 8
- Keep batch samples of bulk formulated products available for MHRA inspection Manufacturer
Browse 16 other sections
Principles
sch. 1 para. 14
sch. 1 para. 15
sch. 1 para. 16
sch. 1 para. 5
sch. 1 para. 7
sch. 1 para. 8
sch. 3 para. 1
sch. 3 para. 3
sch. 3 para. 4
sch. 3 para. 5
sch. 7 para. 9
(1) The conditions and principles specified in Part 2 apply...
The minor has received information according to his capacity of...
The clinical trial is necessary to validate data obtained—
The corresponding scientific guidelines of the European Medicines Agency are...
Official guidance
Authoritative sources published by regulators or government explaining this legislation.
- Licensing exemptions | Human Tissue Authority (opens in a new tab) from HTA Detailed Guidance
- Code E: Consent | Human Tissue Authority (opens in a new tab) from HTA Code of Practice
- Consent to research - professional standards - GMC (opens in a new tab) from GMC Detailed Guidance
- Making decisions - professional standards - GMC (opens in a new tab) from GMC Detailed Guidance
- HRA clinical trials reform guidance (opens in a new tab) Detailed Guidance
Enforcement and responsible bodies
The regulators that administer or enforce this legislation.
Medicines and Healthcare products Regulatory Agency
Regulates medicines, medical devices, and blood components. Ensures safety, quality, and efficacy. Issues marketing authorisations.
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Regulators
Learn more about the bodies that enforce this legislation.