UK Statutory Instrument 2004 United Kingdom

Medicines for Human Use (Clinical Trials) Regulations 2004

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At a glance

Enforced by

MHRA

What's here

24 compliance obligations, 2 practical guides · 1 journey

Penalty landscape

4 of 24 obligations carry up to 2 years imprisonment. 20 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.

  • Client 10
  • Any Person 8
  • Applicant 2
  • Manufacturer 1

Plus 3 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 guides

Mentioned in related content

1 guides

Other 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.

Clients also bound by 30 other Acts (top 5 shown)
Any Person also bound by 749 other Acts (top 5 shown)
Applicants also bound by 146 other Acts (top 5 shown)
Manufacturers also bound by 82 other Acts (top 5 shown)

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

s.list of countries for the purpose of the definitio

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
s.sponsor’s responsibility for the investigator’s br

Sponsor’s responsibility for the investigator’s brochure

  • Maintain and update the Clinical Trial Investigator’s Brochure Client
Browse 2 other sections in this Part — procedural / definitional / commencement

Part 2 — ETHICS COMMITTEES

Browse 5 other sections in this Part — procedural / definitional / commencement

Part 3 — AUTHORISATION FOR CLINICAL TRIALS AND ETHICS COMMITTEE OPINION

Browse 12 other sections in this Part — procedural / definitional / commencement
s.information sharing

Information sharing

s.publication of information

Publication of information

Part 4 — GOOD CLINICAL PRACTICE AND THE CONDUCT OF CLINICAL TRIALS

s.notification of serious breaches

Notification of serious breaches

  • Notify MHRA of serious breaches in clinical trials Client
s.trial master file and archiving

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

Browse 1 other section in this Part — procedural / definitional / commencement

Part 6 — MANUFACTURE AND IMPORTATION OF INVESTIGATIONAL MEDICINAL PRODUCTS

s.approved country for import

Approved country for import

Other duties (1) — Crown / regulator
  • MHRA must maintain and review the list of approved countries for import Statutory regulator
Browse 11 other sections in this Part — procedural / definitional / commencement
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 6A — NON-INVESTIGATIONAL MEDICINAL AND NON-MEDICINAL PRODUCTS

No sections of this Part have been ingested yet.

Part 7 — LABELLING

Browse 1 other section in this Part — procedural / definitional / commencement

Part 8 — ENFORCEMENT AND RELATED PROVISIONS

s.049

Offences

2 years imprisonment
  • Breach listed clinical‑trial regulations Any Person
s.052

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

Browse 3 other Schedules — structural / supplementary
Read the full Act on legislation.gov.uk (opens in a new tab)

Official guidance

Authoritative sources published by regulators or government explaining this legislation.

Enforcement and responsible bodies

The regulators that administer or enforce this legislation.

MHRA

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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Browse legislation

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Regulators

Learn more about the bodies that enforce this legislation.