| Guvnor

Enforced by: MHRA, GOC, GPhC, VMD
Status: Amended (in force with amendments)
Penalty ceiling: Imprisonment 9 of 28 obligations carry up to 2 years imprisonment. 3 carry different penalties and 16 have no criminal penalty — flagged in the list below.

Does it bind you?

Business-side roles with duties under this instrument.

Any Person7 Trader4 Director or Officer3 Landlord1 Applicant1

Plus 12 duties on the regulator, Crown ministers and public bodies — folded into the section list below.

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

Trader — also bound by 825 other Acts

Value Added Tax Regulations 1995 416 duties

Companies Act 2006 243 duties

The Large and Medium-sized Companies and Groups (Accounts and Reports) Regulations 2008 133 duties

Companies Act 1985 85 duties

Insolvency (England and Wales) Rules 2016 62 duties

Director or Officer — also bound by 429 other Acts

Insolvency (England and Wales) Rules 2016 162 duties

Companies Act 2006 126 duties

Insolvency Act 1986 77 duties

The Large and Medium-sized Companies and Groups (Accounts and Reports) Regulations 2008 68 duties

Building Societies Act 1986 32 duties

Landlord — also bound by 224 other Acts

Renting Homes (Wales) Act 2016 74 duties

Housing Act 1985 55 duties

Housing Act 1996 30 duties

The Service Charges (Consultation Requirements) (England) Regulations 2003 27 duties

The Service Charges (Consultation Requirements) (Wales) Regulations 2004 26 duties

Applicant — also bound by 307 other Acts

Insolvency (England and Wales) Rules 2016 46 duties

Human Medicines Regulations 2012 42 duties

The Land Registration Rules 2003 25 duties

Regulation (EU) No 1178/2011 (Aircrew) 20 duties

Value Added Tax Regulations 1995 18 duties

What it requires

Sections 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

Administration

0 of 6 sections shown

6 other sections in this Part — procedural and definitional

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 2

Licences and Certificates Relating to Medicinal Products

0 of 47 sections shown

47 other sections in this Part — procedural and definitional

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 3

Further Provisions relating to Dealings with Medicinal Products

3 of 26 sections shown

s.063 Adulteration of medicinal products. Imprisonment

Do not adulterate medicinal products or sell adulterated medicinesAny Person

s.064 Protection of purchasers of medicinal products. Imprisonment

Ensure medicinal products meet the quality and nature requested by customersAny Person

s.067 Offences under Part III. Imprisonment

Breach regulations on prescribing, selling, or possessing medicinal productsAny Person

23 other sections in this Part — procedural and definitional

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 4

Pharmacies

10 of 33 sections shown

s.071 Business carried on by body corporate Regulated

Appoint a Superintendent and Responsible Pharmacist for pharmacy businessesDirector or Officer

s.072 The superintendent Prosecution

Ensure safe and effective running of your retail pharmacy businessDirector or Officer

Unlimited fine

s.074 Registration of premises: Great Britain Imprisonment

Other duties (1) — Crown / regulator

s.074 Supplementary provision in respect of registration of premises: Great Britain Regulated

Apply to restore a pharmacy premises to the registerLandlord

s.074 Giving of notice by registrar: Great Britain Regulated

Other duties (1) — Crown / regulator

Registrar must provide written confirmation or refusal of pharmacy registrationStatutory regulator

s.075 Registration of premises : Northern Ireland. Regulated

s.076 Supplementary provisions as to registration of premises : Northern Ireland. Regulated

Pay annual pharmacy retention fee and notify of ownership changesTrader

s.077 Annual return of premises to registrar. Prosecution

Submit annual return of pharmacy premises in Northern IrelandTrader

Fine up to £1,000

s.078 Restrictions on use of titles, descriptions and emblems. Prosecution

Use protected pharmacy titles and descriptions only if registeredAny Person

Unlimited fine

s.082 Procedure relating to disqualification. Regulated

Other duties (1) — Crown / regulator

High Court or Court of Session must determine appeals against disqualificationTribunal / Court

23 other sections in this Part — procedural and definitional

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 5

Containers, Packages and Identification of Medicinal Products

2 of 7 sections shown

s.087 Requirements as to containers. Imprisonment

Ensure medicinal product containers meet legal safety and quality standardsTrader

s.088 Distinctive colours, shapes and markings of medicinal products. Regulated

Do not sell medicines with illegal colours, shapes, or markingsTrader

5 other sections in this Part — procedural and definitional

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 6

Promotion of Sales of Medicinal Products

0 of 6 sections shown

6 other sections in this Part — procedural and definitional

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 7

British Pharmacopoeia and Other Publications

3 of 6 sections shown

s.101 Other publications.

amended 2 times (opens in a new tab)

s.102 Supplementary provisions.

amended 6 times (opens in a new tab)

s.103 Construction of references to specified publications.

amended 3 times (opens in a new tab)

3 other sections in this Part — procedural and definitional

s.098 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..

s.099 New editions of British Pharmacopoeia, and other compendia.

s.100 Lists of names.

Part 8

Miscellaneous and Supplementary Provisions

31 of 34 sections shown

s.104 Application of the 2012 Regulations to certain articles and substances.

amended 4 times (opens in a new tab)

s.105 Application of the 2012 Regulations to certain other substances which are not medicinal products.

amended 4 times (opens in a new tab)

s.107 Validity of decisions and proceedings relating thereto.

amended 7 times (opens in a new tab)

s.108 Enforcement in England and Wales. Regulated

Other duties (1) — Crown / regulator

GPhC must enforce medicine retail and supply regulationsStatutory regulator

amended 38 times (opens in a new tab)

s.109 Enforcement in Scotland. Regulated

Other duties (1) — Crown / regulator

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

amended 10 times (opens in a new tab)

s.110 Enforcement in Northern Ireland. Regulated

Other duties (1) — Crown / regulator

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

amended 29 times (opens in a new tab)

s.111 Rights of entry.

amended 10 times (opens in a new tab)

s.112 Power to inspect, take samples and seize goods and documents.

amended 1 time (opens in a new tab)

s.113 Application of sampling procedure to substance or article seized under s. 112.

amended 1 time (opens in a new tab)

s.114 Supplementary provisions as to rights of entry and related rights. Imprisonment

Obstructing inspectors or providing false informationAny Person

2 years imprisonment · amended 3 times (opens in a new tab)

s.116 Liability to forfeiture under Customs and Excise Act 1952.

amended 1 time (opens in a new tab)

s.117 Special enforcement and sampling provisions relating to animal feeding stuffs.

amended 1 time (opens in a new tab)

s.118 Restrictions on disclosure of information. Imprisonment

Unlawfully disclose trade secrets or manufacturing dataAny Person

2 years imprisonment · amended 6 times (opens in a new tab)

s.119 Protection for officers of enforcement authorities.

amended 7 times (opens in a new tab)

s.120 Compensation for loss of employment or loss or diminution of emoluments.

amended 1 time (opens in a new tab)

s.121 Contravention due to default of other person.

amended 3 times (opens in a new tab)

s.122 Warranty as defence.

amended 3 times (opens in a new tab)

s.123 Offences in relation to warranties and certificates of analysis. Imprisonment

Provide false warranties or misuse analysis certificatesAny Person

2 years imprisonment · amended 1 time (opens in a new tab)

s.124 Offences by bodies corporate. Imprisonment

Personal liability for directors and officers for company offencesDirector or Officer

2 years imprisonment · amended 3 times (opens in a new tab)

s.125 Prosecutions.

amended 6 times (opens in a new tab)

s.126 Presumptions.

amended 14 times (opens in a new tab)

s.127 Service of documents.

amended 4 times (opens in a new tab)

s.128 Financial provisions.

amended 5 times (opens in a new tab)

s.129 Orders and regulations.

amended 18 times (opens in a new tab)

s.130 Meaning of “medicinal product" and related expressions.

amended 19 times (opens in a new tab)

s.131 Meaning of “wholesale dealing", “retail sale" and related expressions.

amended 5 times (opens in a new tab)

s.132 General interpretation provisions.

amended 46 times (opens in a new tab)

s.133 General provisions as to operation of Act.

amended 2 times (opens in a new tab)

s.134 Special provisions as to Northern Ireland.

amended 4 times (opens in a new tab)

s.135 Minor and consequential amendments and repeals.

amended 1 time (opens in a new tab)

s.136 Short title, extent and commencement.

amended 1 time (opens in a new tab)

3 other sections in this Part — procedural and definitional

s.106 Extension of references to carrying on business.

s.115 Analysis of samples in other cases.

s.115 Facilities for microbiological examinations.

Schedules

6 of 83 shown

s.sch003 Any such arrangements as are mentioned in paragraph 15(b) or... Regulated

Other duties (1) — Crown / regulator

Enforcement authorities must obtain Secretary of State approval for certain arrangementsStatutory regulator

s.sch003 (1) Subject to the following sub-paragraph, the person to whom... Regulated

Other duties (1) — Crown / regulator

Promptly analyse or examine submitted samplesLocal authority

s.sch003 (1) A public analyst who has analysed a sample submitted... Regulated

Other duties (1) — Crown / regulator

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

s.sch003 (1) Where a sampling officer takes a sample in the... Regulated

Other duties (1) — Crown / regulator

Sampling officers must pay for samples when demandedStatutory regulator

s.sch003 In any case not falling within any of paragraphs 3... Regulated

Other duties (1) — Crown / regulator

Sampling officer must give one part of sample to the ownerStatutory regulator

s.sch003 In every case falling within any of paragraphs 3, 4,... Regulated

Other duties (1) — Crown / regulator

Sampling officer must inform recipient that sample is for analysisStatutory regulator

77 other schedules

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.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 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 (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 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.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 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.

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

Healthcare compliance quick check

Quick compliance check for experienced healthcare providers. Covers CQC registration, professional registrations, DBS checks, medicines audit, controlled drugs register, IPC audit, fire …

Respond to a medicines or controlled drugs incident

What to do when a medicines incident occurs: medication error, controlled drug discrepancy, or CD theft/loss. Covers securing the patient and evidence, …

6 more guides that reference this instrument

MHRA authorisation for medicines and medical devices MHRA licensing for medicines and medical devices Medicines and controlled drugs compliance Run a retail pharmacy or optical business Running clinical trials in the UK Healthcare professional registration requirements

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

Medicines Act 1968

Does it bind you?

Other Acts binding the same actors

What it requires

Administration

Licences and Certificates Relating to Medicinal Products

Further Provisions relating to Dealings with Medicinal Products

Pharmacies

Containers, Packages and Identification of Medicinal Products

Promotion of Sales of Medicinal Products

British Pharmacopoeia and Other Publications

Miscellaneous and Supplementary Provisions

Schedules

Help complying

Run a healthcare business

Healthcare compliance quick check

Respond to a medicines or controlled drugs incident