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.

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

Traders also bound by 826 other Acts (top 5 shown)

Value Added Tax Regulations 1995 1995 413 duties
Companies Act 2006 2006 243 duties
The Large and Medium-sized Companies and Groups (Accounts and Reports) Regulations 2008 2008 114 duties
Insolvency (England and Wales) Rules 2016 2016 62 duties
Building Societies Act 1986 1986 56 duties

Directors and Officers also bound by 425 other Acts (top 5 shown)

Insolvency (England and Wales) Rules 2016 2016 161 duties
Companies Act 2006 2006 108 duties
Insolvency Act 1986 1986 72 duties
The Large and Medium-sized Companies and Groups (Accounts and Reports) Regulations 2008 2008 55 duties
The Housing Administration (England and Wales) Rules 2018 2018 26 duties

Landlords also bound by 216 other Acts (top 5 shown)

Renting Homes (Wales) Act 2016 2016 74 duties
Housing Act 1985 1985 53 duties
Housing Act 1996 1996 30 duties
The Service Charges (Consultation Requirements) (England) Regulations 2003 2003 27 duties
The Service Charges (Consultation Requirements) (Wales) Regulations 2004 2004 26 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 I — Administration

Browse 6 other sections in this Part — procedural / definitional / commencement

s.001

Ministers responsible for administration of Act.

s.002

Establishment of Medicines Commission.

s.002

Establishment of the Commission on Human Medicines

s.003

Functions of the Commission

s.004

Establishment of committees.

s.005

Supplementary provisions as to Commission and committees.

Part II — Licences and Certificates Relating to Medicinal Products

Browse 47 other sections in this Part — procedural / definitional / commencement

s.006

The licensing authority.

s.007

General provisions as to dealing with medicinal products.

s.008

Provisions as to manufacture and wholesale dealing.

s.009

Exemptions for doctors and dentists

s.010

Exemptions for pharmacists.

s.011

Exemption for nurses and midwives.

s.012

Exemptions in respect of herbal remedies.

s.013

Exemptions for imports.

s.014

Exemption for re-exports.

s.015

Provision for extending or modifying exemptions.

s.016

Transitional exemptions.

s.017

Termination of transitional exemptions.

s.018

Application for licence.

s.019

Factors relevant to determination of application for licence.

s.020

Grant or refusal of licence.

s.021

Procedure on reference to appropriate committee

s.022

Procedure in other cases.

s.022

Hearing before person appointed

s.023

Special provisions as to effect of manufacturer’s licence.

s.024

Duration and renewal of licence.

s.025

Entitlement to licence of right.

s.026

Scope of licence of right in different cases.

s.027

Proceedings on application for licence of right.

s.028

General power to suspend, revoke or vary licences.

s.029

Procedure where licensing authority propose to suspend, revoke or vary licence under s. 28.

s.030

Variation of licence on application of holder.

s.031

Clinical trials.

s.032

Medicinal tests on animals.

s.033

Exemptions in respect of medicinal tests on animals.

s.034

Restrictions as to animals on which medicinal tests have been carried out.

s.035

Supplementary provisions as to clinical trials and medicinal tests on animals.

s.036

Application for, and issue of, certificate.

s.037

Transitional provisions as to clinical trials and medicinal tests on animals.

s.038

Duration and renewal of certificate.

s.039

Suspension, revocation or variation of certificate.

s.040

Medicated animal feeding stuffs.

s.043

Extension of s. 7 to certain special circumstances.

s.044

Provision of information to licensing authority.

s.045

Offences under Part II.

s.046

Special defences under s. 45.

s.047

Standard provisions for licences

s.048

Postponement of restrictions in relation to exports.

s.049

Special provisions in respect of exporting certain products.

s.049

Special provisions in respect of exporting certain products to member States

s.049

Special provisions in respect of exporting certain products to EEA State s

s.050

Certificates for exporters of medicinal products.

s.4142

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..

Part III — Further Provisions relating to Dealings with Medicinal Products

s.063

Adulteration of medicinal products.

2 years imprisonment

Do not adulterate medicinal products or sell adulterated medicines Any Person

s.064

Protection of purchasers of medicinal products.

2 years imprisonment

Ensure medicinal products meet the quality and nature requested by customers Any Person

s.067

Offences under Part III.

2 years imprisonment

Breach regulations on prescribing, selling, or possessing medicinal products Any Person

Browse 23 other sections in this Part — procedural / definitional / commencement

s.051

General sale lists.

s.052

Sale or supply of medicinal products not on general sale list.

s.053

Sale or supply of medicinal products on general sale list.

s.054

Sale of medicinal products from automatic machines.

s.055

Exemptions for doctors and dentists etc

s.056

Exemptions in respect of herbal remedies.

s.057

Power to extend or modify exemptions.

s.058

Medicinal products on prescription only.

s.058

Requirement to specify certain products as prescription-only products

s.058

Requirement to specify certain products for veterinary use as prescription-only products.

s.059

Special provisions in relation to new medicinal products.

s.060

Restricted sale, supply and administration of certain medicinal products.

s.061

Special restrictions on persons to be supplied with medicinal products.

s.062

Prohibition of sale or supply, or importation, of medicinal products of specified description ....

s.065

Compliance with standards specified in monographs in certain publications.

s.066

Further powers to regulate dealings with medicinal products.

s.067

Defence to offence of contravening section 63(a) or (b): product not sold or supplied

s.067

Defence to offence of contravening section 63(a) or (b): product sold or supplied

s.067

Defence to offence of contravening section 64

s.067

Defences under sections 67A, 67B and 67C: evidence etc.

s.067

Sections 67A to 67D: “adulteration” and “registrant”

s.067

Sections 67A to 67D: “relevant pharmacy service”

s.068

Disqualification on conviction of certain offences.

Part IV — Pharmacies

s.071

Business carried on by body corporate

Appoint a Superintendent and Responsible Pharmacist for pharmacy businesses Director or Officer

s.072

The superintendent

Unlimited fine

Ensure safe and effective running of your retail pharmacy business Director or Officer

s.074

Registration of premises: Great Britain

2 years imprisonment

Other duties (1) — Crown / regulator

s.074

Supplementary provision in respect of registration of premises: Great Britain

Apply to restore a pharmacy premises to the register Landlord

s.074

Giving of notice by registrar: Great Britain

Other duties (1) — Crown / regulator

Registrar must provide written confirmation or refusal of pharmacy registration Statutory regulator

s.075

Registration of premises : Northern Ireland.

s.076

Supplementary provisions as to registration of premises : Northern Ireland.

Pay annual pharmacy retention fee and notify of ownership changes Trader

s.077

Annual return of premises to registrar.

Fine up to £1,000

Submit annual return of pharmacy premises in Northern Ireland Trader

s.078

Restrictions on use of titles, descriptions and emblems.

Unlimited fine

Use protected pharmacy titles and descriptions only if registered Any Person

s.082

Procedure relating to disqualification.

Other duties (1) — Crown / regulator

High Court or Court of Session must determine appeals against disqualification Tribunal / Court

Browse 23 other sections in this Part — procedural / definitional / commencement

s.069

General provisions.

s.070

Business carried on by individual pharmacist or by partners.

s.072

Representative of pharmacist in case of death or disability.

s.072

The responsible pharmacist

s.072

Sections 72A and 72AA: supplementary

s.073

Power to extend or modify conditions.

s.074

Meaning of “registered pharmacy".

s.074

Conditions for registration: Great Britain

s.074

Conditional registration: Great Britain

s.074

Supplementary provision in respect of conditional registration: Great Britain

s.074

Voluntary removal from the register: Great Britain

s.074

Registration of pharmacies

s.074

Supplementary provision in respect of change of ownership of retail pharmacy business: Great Britain

s.074

Temporary registration with regard to emergencies involving loss of human life or human illness etc.

s.074

Temporary annotations with regard to emergencies involving loss of human life or human illness etc.

s.074

Evidence of registration: Great Britain

s.079

Provision for modifying or extending restrictions under s. 78.

s.080

Power for relevant disciplinary committee to disqualify and direct removal from register.

s.081

Grounds for disqualification in certain cases.

s.082

Interim measures

s.083

Revocation of disqualification.

s.084

Offences under Part IV.

s.084

Rules by the General Pharmaceutical Council

Part V — Containers, Packages and Identification of Medicinal Products

s.087

Requirements as to containers.

2 years imprisonment

Ensure medicinal product containers meet legal safety and quality standards Trader

s.088

Distinctive colours, shapes and markings of medicinal products.

Do not sell medicines with illegal colours, shapes, or markings Trader

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

s.085

Labelling and marking of containers and packages.

s.086

Leaflets.

s.089

Display of information on automatic machines.

s.090

Provisions as to medicated animal feeding stuffs.

s.091

Offences under Part V, and supplementary provisions.

Part VI — Promotion of Sales of Medicinal Products

Browse 6 other sections in this Part — procedural / definitional / commencement

s.092

Scope of Part VI.

s.093

False or misleading advertisements and representations.

s.094

Advertisements requiring consent of holder of product licence.

s.095

Powers to regulate advertisements and representations.

s.096

Advertisements and representations directed to practitioners.

s.097

Power for licensing authority to require copies of advertisements.

Part VII — British Pharmacopoeia and Other Publications

s.101

Other publications.

Amended 2 times

s.102

Supplementary provisions.

Amended 6 times

s.103

Construction of references to specified publications.

Amended 3 times

Browse 3 other sections in this Part — procedural / definitional / commencement

s.098

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..

s.099

New editions of British Pharmacopoeia, and other compendia.

s.100

Lists of names.

Part VIII — Miscellaneous and Supplementary Provisions

s.104

Application of the 2012 Regulations to certain articles and substances.

Amended 4 times

s.105

Application of the 2012 Regulations to certain other substances which are not medicinal products.

Amended 4 times

s.107

Validity of decisions and proceedings relating thereto.

Amended 7 times

s.108

Enforcement in England and Wales.

Amended 38 times

Other duties (1) — Crown / regulator

GPhC must enforce medicine retail and supply regulations Statutory regulator

s.109

Enforcement in Scotland.

Amended 10 times

Other duties (1) — Crown / regulator

Secretary of State must ensure enforcement of medicines law in Scotland Crown / Minister / Government department

s.110

Enforcement in Northern Ireland.

Amended 29 times

Other duties (1) — Crown / regulator

Minister and Pharmaceutical Society must enforce medicines laws in NI Crown / Minister / Government department

s.111

Rights of entry.

Amended 10 times

s.112

Power to inspect, take samples and seize goods and documents.

Amended 1 time

s.113

Application of sampling procedure to substance or article seized under s. 112.

Amended 1 time

s.114

Supplementary provisions as to rights of entry and related rights.

2 years imprisonment Amended 3 times

Obstructing inspectors or providing false information Any Person

s.116

Liability to forfeiture under Customs and Excise Act 1952.

Amended 1 time

s.117

Special enforcement and sampling provisions relating to animal feeding stuffs.

Amended 1 time

s.118

Restrictions on disclosure of information.

2 years imprisonment Amended 6 times

Unlawfully disclose trade secrets or manufacturing data Any Person

s.119

Protection for officers of enforcement authorities.

Amended 7 times

s.120

Compensation for loss of employment or loss or diminution of emoluments.

Amended 1 time

s.121

Contravention due to default of other person.

Amended 3 times

s.122

Warranty as defence.

Amended 3 times

s.123

Offences in relation to warranties and certificates of analysis.

2 years imprisonment Amended 1 time

Provide false warranties or misuse analysis certificates Any Person

s.124

Offences by bodies corporate.

2 years imprisonment Amended 3 times

Personal liability for directors and officers for company offences Director or Officer

s.125

Prosecutions.

Amended 6 times

s.126

Presumptions.

Amended 14 times

s.127

Service of documents.

Amended 4 times

s.128

Financial provisions.

Amended 5 times

s.129

Orders and regulations.

Amended 18 times

s.130

Meaning of “medicinal product" and related expressions.

Amended 19 times

s.131

Meaning of “wholesale dealing", “retail sale" and related expressions.

Amended 5 times

s.132

General interpretation provisions.

Amended 46 times

s.133

General provisions as to operation of Act.

Amended 2 times

s.134

Special provisions as to Northern Ireland.

Amended 4 times

s.135

Minor and consequential amendments and repeals.

Amended 1 time

s.136

Short title, extent and commencement.

Amended 1 time

Browse 3 other sections in this Part — procedural / definitional / commencement

s.106

Extension of references to carrying on business.

s.115

Analysis of samples in other cases.

s.115

Facilities for microbiological examinations.

Schedules

s.sch003

(1) Subject to the following sub-paragraph, the person to whom...

Other duties (1) — Crown / regulator

Promptly analyse or examine submitted samples Local authority

s.sch003

(1) A public analyst who has analysed a sample submitted...

Other duties (1) — Crown / regulator

Public analysts and lab managers must issue certificates of analysis to sampling officers Local authority

Browse 81 other Schedules — structural / supplementary

s.003

SAMPLING

s.sch001

Provisions Relating to Medicines Commission and Committees

s.sch001

The Ministers may make provision by regulations with respect to...

s.sch001

The Ministers shall provide the Commission and each committee established...

s.sch001

The validity of any proceedings of the Commission or of...

s.sch001

The Commission and any such committee or sub-committee shall have...

s.sch001

The Ministers may pay to the members of the Commission...

s.sch001

The Ministers shall defray any expenses incurred with their approval...

s.sch001

Neither the Commission nor any such committee or sub-committee shall...

s.sch001a

PROVISIONS RELATING TO COMMISSION AND COMMITTEES

s.sch001a

Interpretation

s.sch001a

Remuneration and expenses of members

s.sch001a

Expenses of Advisory Bodies and Expert Advisory Groups

s.sch001a

Status

s.sch001a

Co-opted members

s.sch001a

Expert Advisory Groups

s.sch001a

Appointment by the Commission of Expert Advisory Groups

s.sch001a

Delegation of functions by Advisory Bodies

s.sch001a

Terms of office of members

s.sch001a

Staff, premises and facilities

s.sch001a

Validity of proceedings

s.sch001a

Proceedings

s.sch002

SUSPENSION, REVOCATION OR VARIATION OF LICENCE

s.sch002

SUSPENSION, REVOCATION OR VARIATION OF LICENCE

s.sch002

SUSPENSION, REVOCATION OR VARIATION OF LICENCE

s.sch002

SUSPENSION, REVOCATION OR VARIATION OF LICENCE

s.sch002

SUSPENSION, REVOCATION OR VARIATION OF LICENCE

s.sch002

SUSPENSION, REVOCATION OR VARIATION OF LICENCE

s.sch002

SUSPENSION, REVOCATION OR VARIATION OF LICENCE

s.sch002

SUSPENSION, REVOCATION OR VARIATION OF LICENCE

s.sch002

SUSPENSION, REVOCATION OR VARIATION OF LICENCE

s.sch002

SUSPENSION, REVOCATION OR VARIATION OF LICENCE

s.sch002

SUSPENSION, REVOCATION OR VARIATION OF LICENCE

s.sch002

SUSPENSION, REVOCATION OR VARIATION OF LICENCE

s.sch002

SUSPENSION, REVOCATION OR VARIATION OF LICENCE

s.sch003

(1) The provisions of this Schedule shall have effect where...

s.sch003

Of the remaining parts of the sample into which the...

s.sch003

Where a sample consists of substances or articles enclosed in...

s.sch003

Section 127 of this Act shall have effect in relation...

s.sch003

If after reasonable inquiry the sampling officer is unable to...

s.sch003

(1) Where it appears to the sampling officer that a...

s.sch003

If the sampling officer decides to submit the sample for...

s.sch003

Where the relevant enforcement authority is a Minister or the...

s.sch003

Any such arrangements as are mentioned in paragraph 15(b) or...

s.sch003

The sampling officer shall forthwith divide the sample into three...

s.sch003

(1) Any person to whom, in accordance with paragraphs 2...

s.sch003

In any proceedings for an offence under this Act a...

s.sch003

In any proceedings for an offence under this Act a...

s.sch003

(1) If in any such proceedings before a magistrates’ court...

s.sch003

(1) In any proceedings for an offence under this Act,...

s.sch003

The costs of any analysis or examination under paragraph 24...

s.sch003

In relation to England and Wales section 9 of the...

s.sch003

The Ministers may by order provide that, in relation to...

s.sch003

(1) Where a sampling officer takes a sample in the...

s.sch003

Where a medicinal product is taken as a sample by...

s.sch003

If the sample was purchased by the sampling officer, otherwise...

s.sch003

If the sampling officer obtained the sample from an automatic...

s.sch003

If the sample is of goods consigned from outside the...

s.sch003

If, in a case not falling within any of paragraphs...

s.sch003

If, in a case not falling within any of paragraphs...

s.sch003

In any case not falling within any of paragraphs 3...

s.sch003

In every case falling within any of paragraphs 3, 4,...

s.sch004

Provisions relating to Northern Ireland

s.sch004

(1) the Minister for Health, Social Services and Public Safety...

s.sch004

In this Act any reference to the Department of Health,...

s.sch004

The Statutory Rules (Northern Ireland) Order 1979, except article 5(2)(a)...

s.sch004

Provisions relating to Northern Ireland

s.sch004

Provisions relating to Northern Ireland

s.sch004

Provisions relating to Northern Ireland

s.sch004

Provisions relating to Northern Ireland

s.sch004

The appropriate Northern Ireland Minister may in relation to Northern...

s.sch004

Where an order is made by virtue of paragraph 6...

s.sch004

Every order or regulation under this Act made by the...

s.sch004

In this Schedule “the appropriate Northern Ireland Minister”—

s.sch005

Amendments of Enactments of Parliament of United Kingdom.

s.sch005

Schedule 5 para.1

s.sch005

Schedule 5 para.10

s.sch005

Schedule 5 para.16

s.sch005

In section 22, in subsection (2), after the words “the...

s.sch006

Enactments of Parliament of United Kingdom Repealed.

s.sch008

Enactments of Parliament of Northern Ireland Repealed.

Read the full Act on legislation.gov.uk

Official guidance

Authoritative sources published by regulators or government explaining this legislation.

MHRA — medicines and healthcare products regulation (opens in a new tab) Detailed Guidance
General Optical Council (opens in a new tab) Detailed Guidance
Appendix 1: Extracts from relevant UK legislation (opens in a new tab) from Ofcom Detailed Guidance
Information note on Regulation 3 - Drinking Water Inspectorate (opens in a new tab) from DWI Detailed Guidance
Nodyn gwybodaeth ar Reoliad 3 (Cymru) - Drinking Water Inspectorate (opens in a new tab) from DWI Detailed Guidance
Information note on Regulation 3 (Wales) - Drinking Water Inspectorate (opens in a new tab) from DWI Detailed Guidance
Windsor Framework device guidance (opens in a new tab) from MHRA Detailed Guidance
GMP guidance (opens in a new tab) from MHRA 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.

MHRA

Primary

Medicines and Healthcare products Regulatory Agency

Regulates medicines, medical devices, and blood components. Ensures safety, quality, and efficacy. Issues marketing authorisations.