| Guvnor

Enforced by: MHRA
Status: Amended (in force with amendments)
Penalty ceiling: Imprisonment 1 of 2 obligations carry up to 2 years imprisonment. 1 has no criminal penalty — flagged in the list below.

Does it bind you?

Business-side roles with duties under this instrument.

Any Person1 Client1

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

Human Medicines Regulations 2012 184 duties

Merchant Shipping Act 1995 144 duties

Insolvency (England and Wales) Rules 2016 104 duties

Communications Act 2003 92 duties

Road Traffic Act 1988 92 duties

Client — also bound by 62 other Acts

Construction (Design and Management) Regulations 2015 32 duties

The Building (Higher-Risk Buildings Procedures) (Wales) Regulations 2025 19 duties

Building (Higher-Risk Buildings Procedures) (England) Regulations 2023 17 duties

Building Regulations (Northern Ireland) 2012 14 duties

Building Regulations 2010 12 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

General

0 of 2 sections shown

2 other sections in this Part — procedural and definitional

s.001 Citation, commencement and extent

s.002 Amendment of the Medicines for Human Use (Clinical Trials) Regulations 2004

Part 2

Amendment to Part 1 (Introductory Provisions)

0 of 3 sections shown

3 other sections in this Part — procedural and definitional

s.003 Amendment to regulation 2

s.004 Amendment to regulation 3

s.005 Insertion of new regulation 3B

Part 3

Amendment to Part 2 (Ethics Committees)

0 of 4 sections shown

4 other sections in this Part — procedural and definitional

s.006 Amendment to regulation 5

s.007 Amendment to regulation 6

s.008 Omission of regulations 7 and 8

s.009 Substitution of regulation 9

Part 4

Amendment to Part 3 (Authorisation for Clinical Trials and Ethics Committee Opinion)

0 of 7 sections shown

7 other sections in this Part — procedural and definitional

s.010 Substitution of regulation 11

s.011 Insertion of new regulations 11A and 11B

s.012 Amendment to regulation 12

s.013 Amendment to regulation 13

s.014 Substitution of regulations 14 to 26

s.015 Amendment to regulation 27A

s.016 Substitution of regulation 27B

Part 5

Amendment to Part 4 (Good Clinical Practice and the Conduct of Clinical Trials)

0 of 6 sections shown

6 other sections in this Part — procedural and definitional

s.017 Amendment to regulation 28

s.018 Amendment to regulation 29

s.019 Amendment to regulation 29A

s.020 Amendment to regulation 30

s.021 Amendment to regulation 31

s.022 Amendment to regulation 31A

Part 6

Amendment to Part 5 (Pharmacovigilance)

1 of 4 sections shown

s.023 Insertion of new regulation A32 Regulated

Keep and evaluate records of serious adverse events during clinical trialsClient

3 other sections in this Part — procedural and definitional

s.024 Amendment to regulation 32

s.025 Amendment to regulation 33

s.026 Amendment to regulation 35

Part 7

Amendment to Part 6 (Manufacture and Importation of Investigational Medicinal Products)

0 of 4 sections shown

4 other sections in this Part — procedural and definitional

s.027 Amendment to regulation 36

s.028 Insertion of new regulation 37A

s.029 Amendment to regulation 40

s.030 Amendment to regulation 43

Part 8

Insertion of new Part 6A (Non-Investigational Medicinal and Non-Medicinal Products)

0 of 1 section shown

1 other section in this Part — procedural and definitional

s.031 Insertion of new Part 6A

Part 9

Substitution of Part 7 (Labelling of Investigational Medicinal Products)

0 of 1 section shown

1 other section in this Part — procedural and definitional

s.032 Substitution of Part 7

Part 10

Amendment to Part 8 (Enforcement and Related Provisions)

1 of 3 sections shown

s.034 Amendment to regulation 49 Imprisonment

Supply non‑investigational medicinal product with non‑compliant labeling for a clinical trialAny Person

2 other sections in this Part — procedural and definitional

s.033 Amendment to regulation 48

s.035 Amendment to regulation 50

Part 11

Amendment to Part 9 (Miscellaneous Provisions)

0 of 1 section shown

1 other section in this Part — procedural and definitional

s.036 Amendment to regulation 58

Part 12

Amendment to the Schedules

0 of 6 sections shown

6 other sections in this Part — procedural and definitional

s.037 Amendment to Schedule 1

s.038 Omission of Schedule 2

s.039 Amendment to Schedule 3

s.040 Amendment to Schedule 4

s.041 Amendment to Schedule 5

s.042 Amendment to Schedule 7

Part 13

Consequential provisions

0 of 1 section shown

1 other section in this Part — procedural and definitional

s.043 Amendment of the Medicines (Products for Human Use) (Fees) Regulations 2016

Part 14

Transitional provisions

0 of 2 sections shown

2 other sections in this Part — procedural and definitional

s.044 Amendment to regulation 56

s.045 Insertion of Schedule 14

Help complying

Guvnor’s practical routes through this instrument.

Run a healthcare business

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

1 more guide that reference this instrument

Running clinical trials in the UK

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

Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025

Does it bind you?

Other Acts binding the same actors

What it requires

General

Amendment to Part 1 (Introductory Provisions)

Amendment to Part 2 (Ethics Committees)

Amendment to Part 3 (Authorisation for Clinical Trials and Ethics Committee Opinion)

Amendment to Part 4 (Good Clinical Practice and the Conduct of Clinical Trials)

Amendment to Part 5 (Pharmacovigilance)

Amendment to Part 6 (Manufacture and Importation of Investigational Medicinal Products)

Insertion of new Part 6A (Non-Investigational Medicinal and Non-Medicinal Products)

Substitution of Part 7 (Labelling of Investigational Medicinal Products)

Amendment to Part 8 (Enforcement and Related Provisions)

Amendment to Part 9 (Miscellaneous Provisions)

Amendment to the Schedules

Consequential provisions

Transitional provisions

Help complying

Run a healthcare business