UK Statutory Instrument 2012 United Kingdom

Human Medicines Regulations 2012

View on legislation.gov.uk (opens in a new tab) Ask Guv about this Act

At a glance

Enforced by

MHRA, GOC, GPhC

What's here

222 compliance obligations, 12 practical guides · 5 journeys

Penalty landscape

76 of 222 obligations carry up to 2 years imprisonment. 4 carry different penalties and 142 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.

  • Any Person 110
  • Applicant 20
  • Manufacturer 14
  • Trader 12
  • Licence Holder 11
  • Employer 3
  • Data Controller 1
  • Director or Officer 1

Plus 50 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

3 guides

Supporting — topic alignment

6 guides

Mentioned in related content

3 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.

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)
Traders also bound by 219 other Acts (top 5 shown)
Licence Holders also bound by 50 other Acts (top 5 shown)
Employers also bound by 171 other Acts (top 5 shown)
Data Controllers also bound by 7 other Acts (top 5 shown)
Directors and Officers also bound by 224 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 — General

Browse 5 other sections in this Part — procedural / definitional / commencement
s.definition of advanced therapy medicinal product e

Definition of advanced therapy medicinal product etc.

s.preparation and assembly of medicinal products use

Preparation and assembly of medicinal products used for vaccination or immunisation against coronavirus or in the reformulation of such products

Part 2 — Administration

s.011

British Pharmacopoeia Commission

Other duties (1) — Crown / regulator
  • Ministers must appoint and maintain the British Pharmacopoeia Commission Crown / Minister / Government department
Browse 2 other sections in this Part — procedural / definitional / commencement

Part 3 — Manufacture and distribution of medicinal products and active substances

s.application for brokering registration

Application for brokering registration

  • Register as a broker of medicinal products Any Person
s.approved country for import

Approved country for import

Other duties (1) — Crown / regulator
  • MHRA must maintain and review the approved countries list for medicine imports Statutory regulator
s.brokering in medicinal products

Brokering in medicinal products

  • Register as a medicine broker and follow distribution guidelines Any Person
s.effect of suspension or variation relating to modu

Effect of suspension or variation relating to modular unit or POC site

  • Do not re-approve suspended manufacturing units without a new application Licence Holder
s.grant or refusal of broker’s registration

Grant or refusal of broker’s registration

Other duties (1) — Crown / regulator
  • Licensing authority must determine broker applications within 90 days Statutory regulator
s.manufacturing and assembly of mm medicinal product

Manufacturing and assembly of MM medicinal products: additional requirements

  • Comply with additional manufacturing requirements for MM medicinal products Manufacturer
s.manufacturing of mm medicinal products

Manufacturing of MM medicinal products

2 years imprisonment
  • Hold a manufacturer's licence and follow a master file for MM products Any Person
s.manufacturing of poc medicinal products

Manufacturing of POC medicinal products

2 years imprisonment
  • Obtain a licence and master file to manufacture POC medicines Any Person
s.obligations of licence holder in great britain sup

Obligations of licence holder in Great Britain supplying listed NIMAR products to Northern Ireland

  • Maintain supply and standards for NIMAR medicines to Northern Ireland Licence Holder
s.penalties

Penalties

2 years imprisonment
  • Breach of regulation 45K requirements for human medicines Any Person
s.procedure for determining an application for broke

Procedure for determining an application for broker’s registration

Other duties (1) — Crown / regulator
  • Licensing authority must determine broker registration within 90 days Statutory regulator
s.provision of information

Provision of information

  • Report falsified medicines and maintain compliance systems Trader
s.register for responsible persons (import)

Register for responsible persons (import)

Other duties (1) — Crown / regulator
  • Licensing authority must maintain a register of import responsible persons Statutory regulator
s.requirement as to responsible persons where licenc

Requirement as to responsible persons where licence holder imports from an approved country for import

2 years imprisonment
  • Appoint a Responsible Person (Import) for medicines from approved countries Licence Holder
s.requirements for registration as an importer, manu

Requirements for registration as an importer, manufacturer or distributor of an active substance

2 years imprisonment
  • Comply with Good Practice standards for active medicinal substances Manufacturer
s.variation of a broker’s registration on the applic

Variation of a broker’s registration on the application of the broker

  • Apply in writing to change your broker registration Any Person
s.variation of an active substance registration on a

Variation of an active substance registration on an application from the registered person

  • Apply to change your active substance registration Any Person
Browse 27 other sections in this Part — procedural / definitional / commencement
s.criteria for importation, manufacture or distribut

Criteria for importation, manufacture or distribution of active substances

s.criteria of broker’s registration

Criteria of broker’s registration

s.guidelines on good manufacturing practice and good

Guidelines on good manufacturing practice and good distribution practice

s.interpretation

Interpretation

s.power to suspend or vary a broker’s registration o

Power to suspend or vary a broker’s registration or remove a broker from the register

s.power to suspend or vary or remove an active subst

Power to suspend or vary or remove an active substance registration

s.procedure where licensing authority proposes to su

Procedure where licensing authority proposes to suspend or vary a broker’s registration or remove a broker from the register

s.registration in relation to active substances

Registration in relation to active substances

s.regulations on good manufacturing practice

Regulations on good manufacturing practice

s.suspension of a broker registration in cases of ur

Suspension of a broker registration in cases of urgency

s.variation of mm master file

Variation of MM master file

s.variation of poc master file

Variation of POC master file

Part 4 — Requirement for authorisation

Browse 2 other sections in this Part — procedural / definitional / commencement

Part 5 — Marketing authorisations

s.058

Consideration of application

Other duties (1) — Crown / regulator
  • Licensing authority must decide on marketing authorisations within 210 days Statutory regulator
s.099

Penalties

2 years imprisonment
  • Breach of human medicines regulations and pharmacovigilance duties Any Person
s.application for ukma(uk) relating to similar biolo

Application for UKMA(UK) relating to similar biological medicinal products

  • Submit supplementary data for similar biological medicine applications Applicant
s.applications relating to advanced therapy medicina

Applications relating to advanced therapy medicinal products

  • Provide efficacy and safety follow-up plans for advanced therapy medicines Applicant
s.applications relating to conditional marketing aut

Applications relating to conditional marketing authorisations ...

  • Demonstrate eligibility for a conditional marketing authorisation Applicant
s.applications relating to poc medicinal products

Applications relating to POC medicinal products

  • Provide monitoring plans for Point of Care (POC) medicinal products Applicant
s.consideration of applications in relation to medic

Consideration of applications in relation to medicinal products containing or consisting of genetically modified organisms

Other duties (1) — Crown / regulator
  • Licensing authority must ensure GMO medicinal products meet safety standards Local authority
s.consideration of applications relating to combined

Consideration of applications relating to combined advanced therapy medicinal products

Other duties (1) — Crown / regulator
  • MHRA must assess and factor in device certificates for combined medicines Statutory regulator
s.consideration of applications relating to conditio

Consideration of applications relating to conditional marketing authorisations

  • Include conditional status and renewal date on medicine packaging and leaflets Applicant
s.consideration of applications relating to orphan m

Consideration of applications relating to orphan medicinal products

Other duties (1) — Crown / regulator
  • MHRA must grant orphan marketing authorisations and maintain a public list Statutory regulator
s.obligation of licensing authority in case of chang

Obligation of licensing authority in case of change of classification

Other duties (1) — Crown / regulator
  • MHRA must protect clinical data for new medicine classifications for one year Statutory regulator
s.obligation to provide information relating to meth

Obligation to provide information relating to methods of manufacture and control: MM medicinal products

  • Share manufacturing and control information with the licence holder Any Person
s.obligation to update information supplied in conne

Obligation to update information supplied in connection with parallel import licence application

  • Update the MHRA on parallel import licence information Applicant
s.offences in connection with parallel import licenc

Offences in connection with parallel import licence application

2 years imprisonment
  • Fail to give accurate information in parallel import licence application Any Person
s.offences relating to commission regulation 2016/16

Offences relating to Commission Regulation 2016/161

2 years imprisonment
  • Breach Commission Regulation 2016/161 Any Person
s.other applications including paediatric indication

Other applications including paediatric indications

  • Include safety monitoring details in paediatric medicine applications Applicant
s.post authorisation requirements in relation to ukm

Post authorisation requirements in relation to UKMA(UK)(Category 1) for advanced therapy medicinal products

  • Maintain data and traceability for advanced therapy medicinal products Any Person
s.publication of information relating to paediatric

Publication of information relating to paediatric marketing authorisations

Other duties (1) — Crown / regulator
  • Licensing authority must publish paediatric medicine registers and decisions Statutory regulator
s.urgent safety restrictions: parallel import licenc

Urgent safety restrictions: parallel import licences

2 years imprisonment
  • Fail to comply with urgent safety restrictions on parallel import licence Any Person
Browse 42 other sections in this Part — procedural / definitional / commencement
s.application for renewal of a parallel import licen

Application for renewal of a parallel import licence

s.application for ukma(gb) relating to certain medic

Application for UKMA(GB) relating to certain medicinal products that do not qualify as generic etc

s.application for ukma(gb) relating to generic medic

Application for UKMA(GB) relating to generic medicinal products

s.application for ukma(gb) relating to similar biolo

Application for UKMA(GB) relating to similar biological medicinal products

s.application for ukma(uk) relating to certain medic

Application for UKMA(UK) relating to certain medicinal products that do not qualify as generic etc.

s.application for ukma(uk) relating to generic medic

Application for UKMA(UK) relating to generic medicinal products

s.application of regulations 89 to 94

Application of regulations 89 to 94

s.applications in relation to medicinal products con

Applications in relation to medicinal products containing or consisting of genetically modified organisms

s.condition as to the submitting of samples and othe

Condition as to the submitting of samples and other information to the appropriate authority

s.deferral of initiation or completion of measures i

Deferral of initiation or completion of measures in paediatric investigation plan

s.orphan rewards

Orphan rewards

s.paediatric rewards

Paediatric rewards

s.post authorisation requirements in relation to uk

Post authorisation requirements in relation to UK marketing authorisations to which paediatric specific provisions apply

s.requirement for certain applications to include re

Requirement for certain applications to include results of paediatric investigation plan

s.submitting of samples and other information: eu ma

Submitting of samples and other information: EU marketing authorisations

s.validity of conditional marketing authorisation

Validity of conditional marketing authorisation

s.validity of parallel import licence

Validity of parallel import licence

s.variation of a ukma(gb) or a ukma(uk)(category 1)

Variation of a UKMA(GB) or a UKMA(UK)(Category 1)

s.waiver of production of information in a paediatri

Waiver of production of information in a paediatric investigation plan

Part 6 — Certification of homoeopathic medicinal products

s.122

Penalties

2 years imprisonment
  • Breach of regulations regarding herbal medicines or misleading information Any Person
s.123

Persons liable

2 years imprisonment
  • Employer liable for employee's application offence Employer
Browse 9 other sections in this Part — procedural / definitional / commencement

Part 7 — Traditional herbal registrations

s.149

Urgent safety restrictions

2 years imprisonment
  • Fail to comply with urgent safety restriction duties for traditional herbal registrations Any Person
s.153

Penalties

2 years imprisonment
  • Breach of human medicines regulations Any Person
s.154

Persons liable

2 years imprisonment
  • Employer liable for employee's medicines application offence Employer
s.procedure where less than 15 years use of traditio

Procedure where less than 15 years use of traditional herbal medicinal product

Other duties (1) — Crown / regulator
  • MHRA may refer traditional herbal medicine applications for expert advice Statutory regulator
s.urgent safety restrictions

Urgent safety restrictions

  • Notify MHRA of urgent safety changes to herbal medicines Any Person
Browse 16 other sections in this Part — procedural / definitional / commencement
s.establishment of herbal monographs

Establishment of herbal monographs

s.interpretation of this part

Interpretation of this Part

s.list of approved countries for traditional use of

List of approved countries for traditional use of a herbal medicinal product

Part 8 — Article 126a authorisations

s.156

Article 126a authorisations

Other duties (1) — Crown / regulator
  • Licensing authority may grant special authorisations for Northern Ireland Statutory regulator
s.157

Requests from EU member States

Other duties (1) — Crown / regulator
  • Licensing authority must share medicine assessment reports with EU member states Local authority
Browse 1 other section in this Part — procedural / definitional / commencement

Part 9 — Borderline products

s.161

Written representations procedure

Other duties (1) — Crown / regulator
  • Licensing authority must review provisional classification of a product Statutory regulator
Browse 6 other sections in this Part — procedural / definitional / commencement

Part 10 — Exceptions to requirement for marketing authorisation etc

s.eams medicinal products: pharmacovigilance

EAMS medicinal products: pharmacovigilance

  • Monitor and report safety data for EAMS medicinal products Any Person
s.early access to medicines scheme: data collection

Early Access to Medicines Scheme: data collection

  • Obtain informed consent before collecting patient data for EAMS medicines Data Controller
s.mm medicinal products: pharmacovigilance requireme

MM medicinal products: pharmacovigilance requirements

  • Maintain records and report side effects for MM medicinal products Any Person
s.poc medicinal products: pharmacovigilance requirem

POC medicinal products: pharmacovigilance requirements

  • Maintain records and report adverse reactions for POC medicinal products Any Person
Browse 13 other sections in this Part — procedural / definitional / commencement
s.advertising of eams medicinal products

Advertising of EAMS medicinal products

s.conditions of temporary authorisations under regul

Conditions of temporary authorisations under regulation 174

s.eams medicinal products: manufacture, assembly, im

EAMS medicinal products: manufacture, assembly, importation, distribution and supply

s.eams scientific opinions ceasing to have effect

EAMS scientific opinions ceasing to have effect

s.early access to medicines scheme: establishment an

Early Access to Medicines Scheme: establishment and licensing authority functions

Part 11 — Pharmacovigilance

s.196

Urgent action

Other duties (1) — Crown / regulator
  • Licensing authority must notify international bodies of urgent safety actions Statutory regulator
s.207

Offences

2 years imprisonment
  • Fail to comply with any requirement of the Human Medicines Regulations Any Person
s.211

Persons liable

2 years imprisonment
  • Employer liable for employee's medicines offence Employer
s.further obligations in respect of pharmacovigilanc

Further obligations in respect of pharmacovigilance activities

  • Maintain pharmacovigilance systems for medicinal products Any Person
s.major safety review by the licensing authority

Major safety review by the licensing authority

Other duties (1) — Crown / regulator
  • MHRA must conduct and publish results of major safety reviews Statutory regulator
s.obligation on holder of a parallel import licence

Obligation on holder of a parallel import licence to submit periodic safety update reports

  • Submit periodic safety update reports for parallel import licences Trader
s.offences in relation to pharmacovigilance obligati

Offences in relation to pharmacovigilance obligations under the Implementing Regulation and Schedule 12A

2 years imprisonment
  • Fail to meet pharmacovigilance obligations Any Person
s.(unknown)

(unknown)

Other duties (1) — Crown / regulator
  • Licensing authority must share drug safety data with the WHO Statutory regulator
Browse 13 other sections in this Part — procedural / definitional / commencement
s.guidance in respect of good pharmacovigilance prac

Guidance in respect of good pharmacovigilance practice and post authorisation efficacy studies

s.licensing authority power in relation to medicinal

Licensing authority power in relation to medicinal products subject to additional monitoring

Part 12 — Dealings with medicinal products

s.253

Pharmacy records

  • Keep records of prescription-only medicine sales and supplies Trader
s.assembly or part-assembly as part of “hub and spok

Assembly or part-assembly as part of “hub and spoke” dispensing arrangements between different businesses

  • Establish written hub-and-spoke dispensing arrangements and notify patients Trader
Browse 41 other sections in this Part — procedural / definitional / commencement
s.electronic prescriptions: approved country health

Electronic Prescriptions: approved country health professionals

s.enforcement notices relating to commission regulat

Enforcement notices relating to Commission Regulation 2016/161: persons authorised to supply medicinal products to the public

s.exception to article 25 of commission regulation 2

Exception to Article 25 of Commission Regulation 2016/161: health care institutions

s.hub and spoke arrangements: sharing of data betwee

Hub and spoke arrangements: sharing of data between different businesses

s.original pack dispensing

Original pack dispensing

s.original pack dispensing: medicinal products conta

Original pack dispensing: medicinal products containing a relevant substance: Northern Ireland

s.original pack dispensing: northern ireland

Original pack dispensing: Northern Ireland

s.protocols relating to coronavirus and influenza va

Protocols relating to coronavirus and influenza vaccinations and immunisations

s.sale etc by a pharmacist in accordance with a seri

Sale etc by a pharmacist in accordance with a serious shortage protocol

s.sale or supply of items dispensed by a pharmacist

Sale or supply of items dispensed by a pharmacist who is absent or treated as absent

Part 12A — Sale of medicines to the public at a distance

s.conditions to be met by a person entered on the li

Conditions to be met by a person entered on the list

  • Display required links and logo for online medicine sales Any Person
s.grant or refusal to list a person

Grant or refusal to list a person

Other duties (1) — Crown / regulator
  • Licensing authority must process applications and publish listing details Statutory regulator
s.offences: breach of regulations and false informat

Offences: breach of regulations and false information

2 years imprisonment
  • Breach of medicines regulations or give false information Any Person
s.procedure for listing persons who may supply medic

Procedure for listing persons who may supply medicinal products at a distance

Other duties (1) — Crown / regulator
  • Licensing authority must decide on distance selling list applications Statutory regulator
s.procedure where the licensing authority proposes t

Procedure where the licensing authority proposes to suspend, vary or remove a person’s entry on the list

Other duties (1) — Crown / regulator
  • Licensing authority must follow set procedures to change or remove a listing Statutory regulator
s.provision of information to the licensing authorit

Provision of information to the licensing authority

2 years imprisonment
  • Report falsified medicines and changes to your register entry Any Person
s.variation of a person’s entry on the list on the a

Variation of a person’s entry on the list on the application of that person

Other duties (1) — Crown / regulator
  • Licensing authority must decide on entry variations within 30 days Statutory regulator
Browse 4 other sections in this Part — procedural / definitional / commencement
s.application of part

Application of Part

s.notification requirements for sellers of medicinal

Notification requirements for sellers of medicinal products at a distance

s.person who may sell medicinal products by informat

Person who may sell medicinal products by information society services

s.power to suspend, vary or remove a person’s entry

Power to suspend, vary or remove a person’s entry on the list

Part 13 — Packaging and leaflets

s.260

Package leaflets

  • Provide a clear and compliant package leaflet for medicinal products Applicant
s.263

Leaflets relating to radionuclides

Other duties (1) — Crown / regulator
  • MHRA must ensure radionuclides include detailed instruction leaflets Statutory regulator
s.266

Language requirements etc

2 years imprisonment
  • Use English for medicinal product information and packaging Manufacturer
s.276

Offences

2 years imprisonment
  • Sell medicinal product in improper container or prohibited aspirin/paracetamol Any Person
s.offence relating to packaging and package leaflets

Offence relating to packaging and package leaflets in Northern Ireland: holder of authorisation etc

2 years imprisonment
  • Fail to provide compliant packaging or leaflets for medicines in NI Any Person
s.offences relating to packaging and package leaflet

Offences relating to packaging and package leaflets in Northern Ireland: other persons

2 years imprisonment
  • Sell medicinal product with non‑compliant packaging or leaflet in NI Any Person
s.packaging requirements: advanced therapy medicinal

Packaging requirements: advanced therapy medicinal products

  • Label and package advanced therapy medicinal products correctly Manufacturer
s.packaging requirements: poc medicinal products

Packaging requirements: POC medicinal products

2 years imprisonment
  • Ensure correct labelling on POC medicinal product packaging Manufacturer
s.packaging requirements: variation in accordance wi

Packaging requirements: variation in accordance with regulation 68(11I)

Other duties (1) — Crown / regulator
  • MHRA may require specific packaging statements for Great Britain medicines Statutory regulator
Browse 9 other sections in this Part — procedural / definitional / commencement
s.guidance as to packaging and package leaflets

Guidance as to packaging and package leaflets

s.packaging requirements: medicinal products require

Packaging Requirements: medicinal products required to bear safety features

s.regulation-making power as to certain forms of lab

Regulation-making power as to certain forms of labelling

s.transitional arrangements

Transitional arrangements

s.transitional arrangements

Transitional Arrangements

Part 14 — Advertising

s.280

General principles

  • Ensure all medicines advertising is accurate, objective, and approved Any Person
s.306

Decision about compatibility

Other duties (1) — Crown / regulator
  • Ministers must issue a final decision on medicine advertisement compatibility Crown / Minister / Government department
s.307

Corrective statement

  • Publish a corrective statement if your medicine advertisement is ruled illegal Any Person
s.308

Offences

2 years imprisonment
  • Fail to comply with MHRA notice or corrective requirement Any Person
s.medicines with differing classification status in

Medicines with differing classification status in Great Britain and Northern Ireland

  • Include regional availability statements in medicine advertisements Trader
Browse 19 other sections in this Part — procedural / definitional / commencement

Part 15 — British Pharmacopoeia

s.318

Lists of names

Other duties (1) — Crown / regulator
  • Government must publish official lists of approved medicine names Crown / Minister / Government department
s.319

Other documents

Other duties (1) — Crown / regulator
  • BPC must prepare and Ministers may publish documents on medicines Statutory regulator
Browse 1 other section in this Part — procedural / definitional / commencement

Part 16 — Enforcement

s.324

Enforcement in Northern Ireland

Other duties (1) — Crown / regulator
  • Minister for Health must enforce medicines regulations in Northern Ireland Crown / Minister / Government department
s.328

Regulation 327: supplementary

Other duties (1) — Crown / regulator
  • Regulators must provide ID and notify owners when seizing items Statutory regulator
s.331

Findings and reports of inspections

Other duties (1) — Crown / regulator
  • Regulators must report on inspection findings and allow business comments Statutory regulator
Browse 8 other sections in this Part — procedural / definitional / commencement
s.guidelines on inspections

Guidelines on inspections

Part 17 — Miscellaneous and general

s.341

Decisions under these Regulations

Other duties (1) — Crown / regulator
  • Licensing authority must provide reasons and appeal info for decisions Statutory regulator
s.344

Payment of expenses by Ministers

Other duties (1) — Crown / regulator
  • Government must pay enforcement expenses to regulators Crown / Minister / Government department
s.346

Review

Other duties (1) — Crown / regulator
  • Secretary of State must review medicines regulations every five years Crown / Minister / Government department
s.obligation on licensing authority to maintain list

Obligation on licensing authority to maintain list of medicinal products to which derogations have applied

Other duties (1) — Crown / regulator
  • Licensing authority must maintain and update list of medicine exemptions Statutory regulator
Browse 10 other sections in this Part — procedural / definitional / commencement
s.modifications to deal with serious shortages

Modifications to deal with serious shortages

s.transitional provision in relation to eu exit

Transitional provision in relation to EU exit

s.transitional provision relating to the windsor fra

Transitional provision relating to the Windsor Framework

Schedules

s.sch007a

Information to be provided for registration as an importer, manufacturer or distributor of active substances

  • Provide required information when registering to handle active substances Manufacturer
s.sch008a

Material to accompany an application for a parallel import licence

  • Submit required documents for a parallel import licence application Applicant
s.sch012a

Further provision as to the performance of pharmacovigilance activities

  • Maintain and update a Pharmacovigilance System Master File (PSMF) Any Person
Browse 11 other Schedules — structural / supplementary
s.sch002a

Modifications of Commission Directive 2003/94/EC

s.sch008b

Modifications of Annex I to the 2001 Directive

s.sch008c

Material to accompany an application for a UK marketing authorisation under the unfettered access route

s.sch009a

Meaning of terms used in the orphan criteria and in regulation 58D

s.sch010a

Variations to a UK marketing authorisation

s.sch033a

Transitional provision in relation to EU Exit

s.sch033b

Transitional Provision in relation to the Windsor Framework

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

Primary

Medicines and Healthcare products Regulatory Agency

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

GOC

General Optical Council

Statutory regulator for optometrists, dispensing opticians, student opticians, and optical businesses in the UK. Registers individuals and businesses, sets standards, and investigates …

GPhC

General Pharmaceutical Council

Statutory regulator for pharmacists, pharmacy technicians, and pharmacy premises in Great Britain. Sets standards for pharmacy education, ethics, and practice. Inspects registered …

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