Run a healthcare business
- 5 steps
UK Act of Parliament
1968
United Kingdom
Medicines Act 1968
At a glance
Who this Act binds
Business-side actors with duties under this Act, ranked by how often they appear.
- Any Person 8
- Trader 4
- Director or Officer 3
- Landlord 1
- Applicant 1
Plus 6 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.
Healthcare compliance quick check
- 2 steps
Respond to a medicines or controlled drugs incident
- 1 step
Relevant guidance
Practical guides for businesses affected by this Act, ordered by how closely they engage with it.
Supporting — topic alignment
5 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.
Any Person also bound by 749 other Acts (top 5 shown)
- Human Medicines Regulations 2012 2012 110 duties
- Licensing Act 2003 2003 105 duties
- Merchant Shipping Act 1995 1995 97 duties
- Road Traffic Act 1988 1988 95 duties
- Air Navigation Order 2016 2016 86 duties
Traders also bound by 219 other Acts (top 5 shown)
- Value Added Tax Regulations 1995 1995 952 duties
- TULRCA 1992 1992 39 duties
- Companies Act 2006 2006 39 duties
- Consumer Contracts (Information, Cancellation and Additional Charges) Regulations 2013 2013 39 duties
- The Customs (Import Duty) (EU Exit) Regulations 2018 2018 33 duties
Directors and Officers also bound by 224 other Acts (top 5 shown)
- Insolvency (England and Wales) Rules 2016 2016 75 duties
- Companies Act 2006 2006 63 duties
- Insolvency Act 1986 1986 46 duties
- CCBSA 2014 2014 22 duties
- CAICEA 2004 2004 18 duties
Landlords also bound by 70 other Acts (top 5 shown)
- Fire Safety (England) Regulations 2022 2022 59 duties
- Renting Homes (Wales) Act 2016 2016 33 duties
- Housing Act 1985 1985 31 duties
- Housing (Scotland) Act 2006 2006 14 duties
- Energy Efficiency (Private Rented Property) (England and Wales) Regulations 2015 2015 10 duties
Applicants also bound by 146 other Acts (top 5 shown)
- Insolvency (England and Wales) Rules 2016 2016 22 duties
- Value Added Tax Regulations 1995 1995 20 duties
- Human Medicines Regulations 2012 2012 20 duties
- Space Industry Regulations 2021 2021 12 duties
- Infrastructure Planning (Environmental Impact Assessment) Regulations 2017 2017 10 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
Ministers responsible for administration of Act.
Establishment of Medicines Commission.
Establishment of the Commission on Human Medicines
Functions of the Commission
Establishment of committees.
Supplementary provisions as to Commission and committees.
Part II — Licences and Certificates Relating to Medicinal Products
Offences under Part II.
2 years imprisonment- Breach of medicinal product licensing requirements Any Person
Browse 46 other sections in this Part — procedural / definitional / commencement
The licensing authority.
General provisions as to dealing with medicinal products.
Provisions as to manufacture and wholesale dealing.
Exemptions for doctors and dentists
Exemptions for pharmacists.
Exemption for nurses and midwives.
Exemptions in respect of herbal remedies.
Exemptions for imports.
Exemption for re-exports.
Provision for extending or modifying exemptions.
Transitional exemptions.
Termination of transitional exemptions.
Application for licence.
Factors relevant to determination of application for licence.
Grant or refusal of licence.
Procedure on reference to appropriate committee
Procedure in other cases.
Hearing before person appointed
Special provisions as to effect of manufacturer’s licence.
Duration and renewal of licence.
Entitlement to licence of right.
Scope of licence of right in different cases.
Proceedings on application for licence of right.
General power to suspend, revoke or vary licences.
Procedure where licensing authority propose to suspend, revoke or vary licence under s. 28.
Variation of licence on application of holder.
Clinical trials.
Medicinal tests on animals.
Exemptions in respect of medicinal tests on animals.
Restrictions as to animals on which medicinal tests have been carried out.
Supplementary provisions as to clinical trials and medicinal tests on animals.
Application for, and issue of, certificate.
Transitional provisions as to clinical trials and medicinal tests on animals.
Duration and renewal of certificate.
Suspension, revocation or variation of certificate.
Medicated animal feeding stuffs.
Extension of s. 7 to certain special circumstances.
Provision of information to licensing authority.
Special defences under s. 45.
Standard provisions for licences
Postponement of restrictions in relation to exports.
Special provisions in respect of exporting certain products.
Special provisions in respect of exporting certain products to member States
Special provisions in respect of exporting certain products to EEA State s
Certificates for exporters of medicinal products.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..
Part III — Further Provisions relating to Dealings with Medicinal Products
Adulteration of medicinal products.
2 years imprisonment- Do not adulterate medicinal products or sell adulterated medicines Any Person
Protection of purchasers of medicinal products.
2 years imprisonment- Ensure medicinal products meet the quality and nature requested by customers Any Person
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
General sale lists.
Sale or supply of medicinal products not on general sale list.
Sale or supply of medicinal products on general sale list.
Sale of medicinal products from automatic machines.
Exemptions for doctors and dentists etc
Exemptions in respect of herbal remedies.
Power to extend or modify exemptions.
Medicinal products on prescription only.
Requirement to specify certain products as prescription-only products
Requirement to specify certain products for veterinary use as prescription-only products.
Special provisions in relation to new medicinal products.
Restricted sale, supply and administration of certain medicinal products.
Special restrictions on persons to be supplied with medicinal products.
Prohibition of sale or supply, or importation, of medicinal products of specified description ....
Compliance with standards specified in monographs in certain publications.
Further powers to regulate dealings with medicinal products.
Defence to offence of contravening section 63(a) or (b): product not sold or supplied
Defence to offence of contravening section 63(a) or (b): product sold or supplied
Defence to offence of contravening section 64
Defences under sections 67A, 67B and 67C: evidence etc.
Sections 67A to 67D: “adulteration” and “registrant”
Sections 67A to 67D: “relevant pharmacy service”
Disqualification on conviction of certain offences.
Part IV — Pharmacies
Business carried on by body corporate
- Appoint a Superintendent and Responsible Pharmacist for pharmacy businesses Director or Officer
The superintendent
Unlimited fine- Ensure safe and effective running of your retail pharmacy business Director or Officer
Registration of premises: Great Britain
2 years imprisonmentOther duties (1) — Crown / regulator
- Register and renew pharmacy premises in Great Britain Statutory regulator
Supplementary provision in respect of registration of premises: Great Britain
- Apply to restore a pharmacy premises to the register Landlord
Giving of notice by registrar: Great Britain
Other duties (1) — Crown / regulator
- Registrar must provide written confirmation or refusal of pharmacy registration Statutory regulator
Registration of premises : Northern Ireland.
- Register pharmacy premises in Northern Ireland Applicant
Supplementary provisions as to registration of premises : Northern Ireland.
- Pay annual pharmacy retention fee and notify of ownership changes Trader
Annual return of premises to registrar.
Fine up to £1,000- Submit annual return of pharmacy premises in Northern Ireland Trader
Restrictions on use of titles, descriptions and emblems.
Unlimited fine- Use protected pharmacy titles and descriptions only if registered Any Person
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
General provisions.
Business carried on by individual pharmacist or by partners.
Representative of pharmacist in case of death or disability.
The responsible pharmacist
Sections 72A and 72AA: supplementary
Power to extend or modify conditions.
Meaning of “registered pharmacy".
Conditions for registration: Great Britain
Conditional registration: Great Britain
Supplementary provision in respect of conditional registration: Great Britain
Voluntary removal from the register: Great Britain
Registration of pharmacies
Supplementary provision in respect of change of ownership of retail pharmacy business: Great Britain
Temporary registration with regard to emergencies involving loss of human life or human illness etc.
Temporary annotations with regard to emergencies involving loss of human life or human illness etc.
Evidence of registration: Great Britain
Provision for modifying or extending restrictions under s. 78.
Power for relevant disciplinary committee to disqualify and direct removal from register.
Grounds for disqualification in certain cases.
Interim measures
Revocation of disqualification.
Offences under Part IV.
Rules by the General Pharmaceutical Council
Part V — Containers, Packages and Identification of Medicinal Products
Requirements as to containers.
2 years imprisonment- Ensure medicinal product containers meet legal safety and quality standards Trader
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
Part VI — Promotion of Sales of Medicinal Products
Browse 6 other sections in this Part — procedural / definitional / commencement
Scope of Part VI.
False or misleading advertisements and representations.
Advertisements requiring consent of holder of product licence.
Powers to regulate advertisements and representations.
Advertisements and representations directed to practitioners.
Power for licensing authority to require copies of advertisements.
Part VII — British Pharmacopoeia and Other Publications
Other publications.
Amended 2 timesSupplementary provisions.
Amended 6 timesConstruction of references to specified publications.
Amended 3 timesBrowse 3 other sections in this Part — procedural / definitional / commencement
Part VIII — Miscellaneous and Supplementary Provisions
Application of the 2012 Regulations to certain articles and substances.
Amended 4 timesApplication of the 2012 Regulations to certain other substances which are not medicinal products.
Amended 4 timesValidity of decisions and proceedings relating thereto.
Amended 7 timesEnforcement in England and Wales.
Amended 38 timesOther duties (1) — Crown / regulator
- GPhC must enforce medicine retail and supply regulations Statutory regulator
Enforcement in Scotland.
Amended 10 timesOther duties (1) — Crown / regulator
- Secretary of State must ensure enforcement of medicines law in Scotland Crown / Minister / Government department
Enforcement in Northern Ireland.
Amended 29 timesOther duties (1) — Crown / regulator
- Minister and Pharmaceutical Society must enforce medicines laws in NI Crown / Minister / Government department
Rights of entry.
Amended 10 timesPower to inspect, take samples and seize goods and documents.
Amended 1 timeApplication of sampling procedure to substance or article seized under s. 112.
Amended 1 timeSupplementary provisions as to rights of entry and related rights.
2 years imprisonment Amended 3 times- Obstructing inspectors or providing false information Any Person
Liability to forfeiture under Customs and Excise Act 1952.
Amended 1 timeSpecial enforcement and sampling provisions relating to animal feeding stuffs.
Amended 1 timeRestrictions on disclosure of information.
2 years imprisonment Amended 6 times- Unlawfully disclose trade secrets or manufacturing data Any Person
Protection for officers of enforcement authorities.
Amended 7 timesCompensation for loss of employment or loss or diminution of emoluments.
Amended 1 timeContravention due to default of other person.
Amended 3 timesWarranty as defence.
Amended 3 timesOffences in relation to warranties and certificates of analysis.
2 years imprisonment Amended 1 time- Provide false warranties or misuse analysis certificates Any Person
Offences by bodies corporate.
2 years imprisonment Amended 3 times- Personal liability for directors and officers for company offences Director or Officer
Prosecutions.
Amended 6 timesPresumptions.
Amended 14 timesService of documents.
Amended 4 timesFinancial provisions.
Amended 5 timesOrders and regulations.
Amended 18 timesMeaning of “medicinal product" and related expressions.
Amended 19 timesMeaning of “wholesale dealing", “retail sale" and related expressions.
Amended 5 timesGeneral interpretation provisions.
Amended 46 timesGeneral provisions as to operation of Act.
Amended 2 timesSpecial provisions as to Northern Ireland.
Amended 4 timesMinor and consequential amendments and repeals.
Amended 1 timeShort title, extent and commencement.
Amended 1 timeBrowse 3 other sections in this Part — procedural / definitional / commencement
Extension of references to carrying on business.
Analysis of samples in other cases.
Facilities for microbiological examinations.
Schedules
Browse 8 other Schedules — structural / supplementary
SAMPLING
Provisions Relating to Medicines Commission and Committees
PROVISIONS RELATING TO COMMISSION AND COMMITTEES
SUSPENSION, REVOCATION OR VARIATION OF LICENCE
Provisions relating to Northern Ireland
Amendments of Enactments of Parliament of United Kingdom.
Enactments of Parliament of United Kingdom Repealed.
Enactments of Parliament of Northern Ireland Repealed.
Official guidance
Authoritative sources published by regulators or government explaining this legislation.
- Windsor Framework device guidance (opens in a new tab) Detailed Guidance
- GMP guidance (opens in a new tab) 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
PrimaryMedicines and Healthcare products Regulatory Agency
Regulates medicines, medical devices, and blood components. Ensures safety, quality, and efficacy. Issues marketing authorisations.
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 …
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 …
Veterinary Medicines Directorate
Executive agency of Defra. Regulates veterinary medicinal products in the UK. Authorises veterinary medicines, monitors safety, and enforces requirements for the manufacture, …
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Regulators
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