| Guvnor

Enforced by: MHRA, GOC, GPhC
Status: Amended (in force with amendments)
Penalty ceiling: Imprisonment 40 of 500 obligations carry up to 2 years imprisonment. 49 carry different penalties and 411 have no criminal penalty — flagged in the list below.

Does it bind you?

Business-side roles with duties under this instrument.

Any Person184 Licence Holder83 Manufacturer75 Applicant42 Trader12 Employer6 Distributor2 Data Controller1 Employee1 Director or Officer1

Plus 93 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

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

Highways Act 1980 85 duties

Licence Holder — also bound by 225 other Acts

Petroleum (Current Model Clauses) Order 1999 318 duties

The Petroleum Licensing (Exploration and Production) (Seaward and Landward Areas) Regulations 2004 123 duties

Space Industry Regulations 2021 68 duties

The Petroleum (Production) (Landward Areas) Regulations 1991 65 duties

The Hornsea One Offshore Wind Farm Order 2014 57 duties

Manufacturer — also bound by 502 other Acts

Pressure Equipment (Safety) Regulations 2016 93 duties

Measuring Instruments Regulations 2016 85 duties

Non-Automatic Weighing Instruments Regulations 2016 78 duties

Commission Delegated Regulation (EU) 2017/654 of 19 December 2016 supplementing Regulation (EU) 2016/1628 of the European Parliament and of the Council with regard to technical and general requirements relating to emission limits and type-approval for internal combustion engines for non-road mobile machinery 76 duties

The Ecodesign for Energy-Related Products and Energy Information Regulations 2021 70 duties

Applicant — also bound by 307 other Acts

Insolvency (England and Wales) Rules 2016 46 duties

The Land Registration Rules 2003 25 duties

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

Value Added Tax Regulations 1995 18 duties

Space Industry Regulations 2021 14 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

Employer — also bound by 682 other Acts

The Income Tax (Pay As You Earn) Regulations 2003 241 duties

Provision and Use of Work Equipment Regulations 1998 120 duties

TULRCA 1992 72 duties

Income Tax (Earnings and Pensions) Act 2003 54 duties

Employment Rights (Northern Ireland) Order 1996 (current NI employment law) 53 duties

Distributor — also bound by 182 other Acts

UK REACH Regulation (retained EU law) 44 duties

The Marketing of Fruit Plant and Propagating Material (England) Regulations 2017 28 duties

The Marketing of Fruit Plant and Propagating Material (Wales) Regulations 2017 26 duties

The Marketing of Fruit Plant and Propagating Material Regulations (Northern Ireland) 2017 25 duties

Electricity Safety, Quality and Continuity Regulations 2002 21 duties

Data Controller — also bound by 35 other Acts

UK GDPR (retained EU law) 127 duties

The Town and Country Planning (Entertainment Resort Complex, Bedford) Special Development (No. 2) Order 2025 50 duties

Data Protection Act 2018 46 duties

Regulation (EU) 2018/1139 (EASA Basic Regulation) 6 duties

Privacy and Electronic Communications Regulations 2003 5 duties

Employee — also bound by 189 other Acts

Regulation (EU) No 965/2012 (Air Operations) 18 duties

Employment Rights (Northern Ireland) Order 1996 (current NI employment law) 13 duties

The Income Tax (Pay As You Earn) Regulations 2003 11 duties

Shared Parental Leave Regulations 2014 10 duties

Paternity and Adoption Leave Regulations 2002 9 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

What it requires

Regulations creating concrete business duties or carrying penalties, grouped as the instrument is structured. Titles link to the source text — blue means you’re leaving for legislation.gov.uk.

Part 1

General

0 of 10 sections shown

10 other sections in this Part — procedural and definitional

s.001 Citation and commencement

s.002 Medicinal products

s.003 Scope of these Regulations: special provisions

s.004 Special provisions for pharmacies etc

s.005 Classification of medicinal products

s.006 The licensing authority and the Ministers

s.007 Advertisements relating to medicinal products

s.008 General interpretation

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

2 of 8 sections shown

s.011 British Pharmacopoeia Commission Regulated

Other duties (1) — Crown / regulator

Ministers must appoint and maintain the British Pharmacopoeia CommissionCrown / Minister / Government department

s.014 Appointment of expert advisory groups Regulated

Other duties (1) — Crown / regulator

MHRA and advisory bodies may appoint expert advisory groupsStatutory regulator

6 other sections in this Part — procedural and definitional

s.009 Commission on Human Medicines

s.010 Functions of the Commission

s.012 Reporting to Ministers

s.013 Co-option of additional members of advisory bodies

s.015 Delegation of functions to expert advisory groups

s.016 Further provision about advisory bodies and expert advisory groups etc

Part 3

Manufacture and distribution of medicinal products and active substances

30 of 66 sections shown

s.017 Manufacturing of MM medicinal products Imprisonment

Hold a manufacturer's licence and follow a master file for MM productsAny Person

s.017 Manufacturing of POC medicinal products Imprisonment

Obtain a licence and master file to manufacture POC medicinesAny Person

s.018 Approved country for import Regulated

Other duties (1) — Crown / regulator

MHRA must maintain and review the approved countries list for medicine importsStatutory regulator

s.021 Application for manufacturer's or wholesale dealer's licence Regulated

Apply for a manufacturer's or wholesale dealer's licenceTrader

s.022 Factors relevant to determination of application for manufacturer's or wholesale dealer's licence Regulated

Other duties (1) — Crown / regulator

Licensing authority must evaluate specific safety and quality criteriaStatutory regulator

s.027 Effect of suspension or variation relating to modular unit or POC site Regulated

Do not re-approve suspended manufacturing units without a new applicationLicence Holder

s.027 Procedure where licensing authority proposes to suspend, revoke or vary licence Regulated

Other duties (1) — Crown / regulator

Licensing authority must follow specific procedures to change or cancel a licenceStatutory regulator

s.031 Certification of manufacturer's licence Regulated

Request a certificate of manufacturer's licence for exporting medicinesLicence Holder

s.033 Offence concerning data for advanced therapy medicinal products Regulated

Fail to keep or transfer ATMP data as requiredManufacturer
Fail to keep or transfer data for advanced therapy medicinal productsManufacturer

s.035 Penalties Imprisonment

Breach of regulations on advanced therapy medicinal products or starting materialsAny Person

s.037 Manufacturing and assembly of MM medicinal products: additional requirements Regulated

Comply with additional manufacturing requirements for MM medicinal productsManufacturer

s.037 Manufacturing and assembly Regulated

Comply with medicine manufacturing, sourcing, and quality standardsLicence Holder

s.038 Imports from states other than EEA States / countries other than approved countries for import Regulated

Ensure medicines and active substances meet import safety standardsLicence Holder

s.039 Further requirements for manufacturer's licence Imprisonment

Maintain adequate staff and facilities for medicine manufacturingLicence Holder

s.041 Requirements as to qualified persons Regulated

Maintain a 'Qualified Person' and notify the MHRA of changesLicence Holder

s.043 Obligations of licence holder in Great Britain supplying listed NIMAR products to Northern Ireland Regulated

Maintain supply and standards for NIMAR medicines to Northern IrelandLicence Holder

s.043 Obligations of licence holder Regulated

Comply with wholesale distribution standards and supply obligationsLicence Holder

s.045 Brokering in medicinal products Regulated

s.045 Requirement as to responsible persons where licence holder imports from an approved country for import Imprisonment

Appoint a Responsible Person (Import) for medicines from approved countriesLicence Holder

s.045 Register for responsible persons (import) Regulated

Other duties (1) — Crown / regulator

Licensing authority must maintain a register of import responsible personsStatutory regulator

s.045 Application for brokering registration Regulated

s.045 Procedure for determining an application for broker’s registration Regulated

Other duties (1) — Crown / regulator

Licensing authority must determine broker registration within 90 daysStatutory regulator

s.045 Grant or refusal of broker’s registration Regulated

Other duties (1) — Crown / regulator

Licensing authority must determine broker applications within 90 daysStatutory regulator

s.045 Provision of information Regulated

Report falsified medicines and maintain compliance systemsTrader

s.045 Variation of a broker’s registration on the application of the broker Regulated

Apply in writing to change your broker registrationAny Person

s.045 Penalties Imprisonment

Breach medicines regulations or provide false informationAny Person
Breach of regulation 45K requirements for human medicinesAny Person

s.045 Requirements for registration as an importer, manufacturer or distributor of an active substance Imprisonment

Comply with Good Practice standards for active medicinal substancesManufacturer

s.045 Variation of an active substance registration on an application from the registered person Regulated

Apply to change your active substance registrationAny Person

s.045 Requirement as to responsible persons Regulated

Appoint and notify a 'Responsible Person' for your medicines licenceLicence Holder

s.criteria of broker’s registration Criteria of broker’s registration Regulated

Maintain ongoing registration criteria as a medicines brokerTrader

36 other sections in this Part — procedural and definitional

s.017 Manufacturing of medicinal products

s.018 Wholesale dealing in medicinal products

s.019 Exemptions from requirement for wholesale dealer's licence

s.020 Mixing of medicines

s.023 Grant or refusal of licence

s.024 Standard provisions of licences

s.025 Duration of licence

s.026 General power to suspend, revoke or vary licences

s.028 Suspension of licence in cases of urgency

s.029 Variation of licence on the application of the holder

s.030 Provision of information

s.032 Sale and supply of starting materials

s.034 Offences: breach of regulations and false information and defence concerning starting materials

s.036 Conditions for manufacturer's licence

s.037 Manufacturing and assembly of POC medicinal products: additional requirements

s.040 Obligation to provide information relating to control methods

s.042 Conditions for wholesale dealer's licence

s.043 Requirement for wholesale dealers to decommission the unique identifier

s.044 Requirement for wholesale dealers to deal only with specified persons

s.045 Offences: breach of regulations and false information

s.045 Provision of information

s.045 Procedure where licensing authority proposes to suspend or vary an active substance registration or remove a person from the active substance register

s.045 Suspension of an active substance registration in cases of urgency

s.045 Offences: breach of regulations and false information

s.045 Penalties

s.criteria for importation, manufacture or distribut Criteria for importation, manufacture or distribution of active substances

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

1 of 2 sections shown

s.047 Breach of requirement Imprisonment

Sell or supply medicines without authorisationAny Person

1 other section in this Part — procedural and definitional

s.046 Requirement for authorisation

Part 5

Marketing authorisations

49 of 95 sections shown

s.050 Other applications including paediatric indications Regulated

Include safety monitoring details in paediatric medicine applicationsApplicant

s.050 Applications relating to advanced therapy medicinal products Regulated

Provide efficacy and safety follow-up plans for advanced therapy medicinesApplicant

s.050 Applications relating to conditional marketing authorisations ... Regulated

Demonstrate eligibility for a conditional marketing authorisationApplicant

s.050 Applications relating to POC medicinal products Regulated

Provide monitoring plans for Point of Care (POC) medicinal productsApplicant

s.051 Application for UKMA(NI) relating to generic medicinal products Regulated

Do not sell generic medicines in Northern Ireland before the allowed dateApplicant

s.052 Application for UKMA(NI) relating to certain medicinal products that do not qualify as generic etc Regulated

Provide specific data when applying for a Northern Ireland Marketing AuthorisationApplicant

s.053 Application for UKMA(UK) relating to similar biological medicinal products Regulated

Submit supplementary data for similar biological medicine applicationsApplicant

s.053 Application for UKMA(NI) relating to similar biological medicinal products Regulated

Provide additional data for 'biosimilar' medicine applicationsApplicant

s.055 Applications relating to new combinations of active substances Regulated

Submit trial data for new drug combinationsApplicant

s.057 Obligation to update information supplied in connection with parallel import licence application Regulated

Update the MHRA on parallel import licence informationApplicant

s.057 Obligation to update information supplied in connection with application Regulated

Update your marketing authorisation application with new informationApplicant

s.058 Publication of information relating to paediatric marketing authorisations Regulated

Other duties (1) — Crown / regulator

Licensing authority must publish paediatric medicine registers and decisionsStatutory regulator

s.058 Consideration of applications relating to orphan medicinal products Regulated

Other duties (1) — Crown / regulator

MHRA must grant orphan marketing authorisations and maintain a public listStatutory regulator

s.058 Consideration of applications relating to combined advanced therapy medicinal products Regulated

Other duties (1) — Crown / regulator

MHRA must assess and factor in device certificates for combined medicinesStatutory regulator

s.058 Consideration of applications relating to conditional marketing authorisations Regulated

Include conditional status and renewal date on medicine packaging and leafletsApplicant

s.058 Consideration of applications in relation to medicinal products containing or consisting of genetically modified organisms Regulated

Other duties (1) — Crown / regulator

Licensing authority must ensure GMO medicinal products meet safety standardsLocal authority

s.058 Consideration of application Regulated

Other duties (1) — Crown / regulator

Licensing authority must decide on marketing authorisations within 210 daysStatutory regulator

s.059 Conditions of UK marketing authorisation or parallel import licence : general Regulated

Incorporate licence conditions into your risk management systemManufacturer

s.061 Conditions of UK marketing authorisation: new obligations post-authorisation Regulated

Comply with post-authorisation obligations and update risk management systemManufacturer

s.062 Classification of UK marketing authorisation or parallel import licence Regulated

Other duties (1) — Crown / regulator

MHRA must classify medicines as prescription-only, pharmacy, or general saleStatutory regulator

s.063 Frequency of periodic safety update reports Imprisonment

Other duties (1) — Crown / regulator

Licensing authority must specify frequency for safety reports in authorisationsLocal authority

s.064 Obligation of licensing authority in case of change of classification Regulated

Other duties (1) — Crown / regulator

MHRA must protect clinical data for new medicine classifications for one yearStatutory regulator

s.064 Duties of licensing authority in connection with determination Regulated

Other duties (1) — Crown / regulator

MHRA must publish medicine authorisation details and assessment reportsStatutory regulator

s.066 Application for renewal of authorisation Regulated

Apply to renew your UK marketing authorisationApplicant

s.072 Sale etc of suspended medicinal product Imprisonment

Do not sell or supply medicines that have been suspendedAny Person

s.073 Obligation to notify placing on the market etc Regulated

Notify the MHRA when medicines are marketed or withdrawnTrader

s.074 Obligation to provide information relating to methods of manufacture and control: MM medicinal products Regulated

Share manufacturing and control information with the licence holderAny Person

s.074 Obligation to provide information relating to methods of manufacture and control: POC medicinal products Regulated

Provide manufacturing and control info to the POC licence holderManufacturer

s.074 Obligation to take account of scientific and technical progress Regulated

Review and update medicine manufacturing methods as science progressesAny Person

s.075 Obligation to provide information relating to safety etc Regulated

Report new safety info and trial results for medicinesAny Person

s.076 Obligation in relation to product information Regulated

Keep medicine product information up to date with scientific knowledgeTrader

s.077 Record-keeping obligations Regulated

Keep records to facilitate product recalls or withdrawalsAny Person

s.078 Post authorisation requirements in relation to UKMA(UK)(Category 1) for advanced therapy medicinal products Regulated

Maintain data and traceability for advanced therapy medicinal productsAny Person

s.078 Obligation to ensure appropriate and continued supplies Regulated

Ensure continuous supply of medicines to the UK marketAny Person

s.079 Failure to provide information on marketing authorisations to EMA Regulated

Fail to submit marketing authorisation information to EMAAny Person
Fail to submit required EMA information for marketing authorisationsAny Person

s.080 Urgent safety restrictions: parallel import licences Imprisonment

Fail to comply with urgent safety restrictions on parallel import licenceAny Person

s.080 Urgent safety restrictions Regulated

Fail to comply with urgent safety restrictions on medicinesAny Person

s.089 Offences in connection with withdrawal of product from the market Prosecution

Cease supply of authorised medicine without proper transfer or EMA noticeAny Person
Withdraw a paediatric medicine from the market illegallyAny Person

Unlimited fine

s.090 Failure to place on the market taking account of paediatric indication Prosecution

Fail to place paediatric medicine on the marketAny Person
Fail to place product on market with paediatric indicationAny Person

Unlimited fine

s.093 Failure to notify results of paediatric study Regulated

Fail to notify paediatric study resultsAny Person
Fail to submit paediatric study results on timeAny Person

s.094 Offences relating to Commission Regulation 2016/161 Regulated

Breach Commission Regulation 2016/161 on medicine safety featuresAny Person

s.095 Offences in connection with parallel import licence application Imprisonment

Fail to give accurate information in parallel import licence applicationAny Person
Provide false or incomplete information in parallel import licence applicationAny Person

s.095 Offences in connection with application Prosecution

Fail to give truthful information in a marketing authorisation applicationAny Person
Give false or incomplete info in a medicine licence applicationAny Person

Unlimited fine

s.096 Provision of false or misleading information Regulated

Provide false or misleading information about a medicinal productAny Person
Provide false or misleading information to regulatorsAny Person

s.097 Breach of pharmacovigilance condition Regulated

Breach of pharmacovigilance conditionAny Person
Fail to comply with pharmacovigilance conditionsAny Person

s.098 General offence of breach of provision of this Part Regulated

Breach any provision of the Human Medicines RegulationsAny Person
Breach of human medicines regulations requirementsAny Person

s.099 Penalties Imprisonment

Breach human medicines regulationsAny Person
Breach of human medicines regulations and pharmacovigilance dutiesAny Person

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. Regulated

Provide additional test or trial results for non-generic UKMA(UK) applicationsApplicant

s.condition as to the submitting of samples and othe Condition as to the submitting of samples and other information to the appropriate authority Regulated

Submit batch samples of biological medicines for testing before saleManufacturer

46 other sections in this Part — procedural and definitional

s.048 Application of this Part

s.049 Application for grant of UK marketing authorisation or parallel import licence

s.050 Agreement and modification of paediatric investigation plan

s.050 Application for paediatric use marketing authorisation

s.050 Applications relating to orphan medicinal products

s.050 Accompanying material

s.054 Applications relating to products in well-established medicinal use

s.056 Applications containing information supplied in relation to another product with consent

s.060 Conditions of UK marketing authorisation or parallel import licence : exceptional circumstances

s.065 Validity of UK marketing authorisation

s.066 Renewal of conditional marketing authorisation

s.067 Failure to place on the market etc

s.068 Revocation, variation and suspension of UK marketing authorisation or parallel import licence

s.069 Suspension of use etc of relevant medicinal product

s.070 Authorisations granted under Chapter 4 of Title III of the 2001 Directive

s.071 Withdrawal of medicinal product from the market

s.081 Obligation to update information supplied in connection with EU application

s.082 EU marketing authorisations: failure to notify placing on market etc

s.083 EU marketing authorisations: failure to take account of technical and scientific progress

s.084 EU marketing authorisations: failure to provide information as to safety etc

s.085 EU marketing authorisations: failure to update product information

s.086 EU marketing authorisations: breach of pharmacovigilance condition etc

s.087 Offences in connection with risk management systems and traceability systems

s.088 Offence concerning data for advanced therapy medicinal products

s.091 Failure to notify results of third country clinical trials

s.092 Failure of sponsor of UK paediatric clinical trial to notify results of trial

s.094 Failure to submit report to EMA

s.100 Persons liable

s.101 Defences

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 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.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

13 of 23 sections shown

s.106 Classification of certificate of registration Regulated

Other duties (1) — Crown / regulator

Licensing authority must classify medicine registration certificatesStatutory regulator

s.108 Application for renewal of certificate Regulated

Apply to renew your homeopathic medicine registrationApplicant

s.113 Obligation to notify placing on the market etc Regulated

Notify the MHRA of medicine market entry, withdrawals, and sales volumesAny Person

s.114 Obligation to take account of scientific and technical progress Regulated

Keep product manufacturing and control methods up to dateManufacturer

s.115 Obligation to provide information relating to safety etc Regulated

Report safety updates and risks to the licensing authorityManufacturer

s.116 Obligation in relation to product information Regulated

Keep medicine product information up to date with scientific knowledgeAny Person

s.117 Record-keeping obligation Regulated

Keep records to help with product recalls or withdrawalsAny Person

s.118 Obligation to ensure appropriate and continued supplies Regulated

Ensure continuous supply of registered medicines to meet patient needsAny Person

s.119 Offences in connection with applications Regulated

Fail to give correct information on homoeopathic medicine registrationAny Person
Fail to supply or provide false information in homeopathic product applicationAny Person

s.120 Provision of false or misleading information Imprisonment

Provide false or misleading information to the MHRAAny Person

s.121 General offence of breach of provision of this Part Imprisonment

Breach of human medicine registration or licensing requirementsAny Person

s.122 Penalties Imprisonment

Breach of regulations regarding herbal medicines or misleading informationAny Person
Commit an offence under the Human Medicines RegulationsAny Person

s.123 Persons liable Regulated

Be liable for employee's offence under regulation 119Employer
Employer liable for employee's application offenceEmployer

10 other sections in this Part — procedural and definitional

s.102 Application of Part

s.103 Application for certificate of registration

s.104 Consideration of application

s.105 Conditions of certificate of registration

s.107 Validity of certificate of registration

s.109 Failure to place on the market etc

s.110 Revocation, variation and suspension of certificate of registration

s.111 Certificates granted under Chapter 4 of Title III of the 2001 Directive

s.112 Withdrawal of homoeopathic medicinal product from the market

s.124 Defences

Part 7

Traditional herbal registrations

19 of 37 sections shown

s.129 Obligation to update information supplied in connection with application Regulated

Update herbal medicine registration applications with new safety dataApplicant

s.130 Procedure where less than 15 years use of traditional herbal medicinal product Regulated

Other duties (1) — Crown / regulator

MHRA may refer traditional herbal medicine applications for expert adviceStatutory regulator

s.131 Classification of traditional herbal registration Regulated

Categorise traditional herbal products for saleTrader

s.133 Application for renewal of registration Regulated

Apply to renew your traditional herbal registrationApplicant

s.141 Sale etc of suspended traditional herbal medicinal product Imprisonment

Do not sell or supply suspended traditional herbal medicinal productsAny Person

s.142 Obligation to notify placing on the market etc Regulated

Notify the MHRA when herbal products are launched or withdrawnAny Person

s.143 Obligation to take account of scientific and technical progress Regulated

Keep herbal medicine manufacturing methods up to date with scientific progressTrader

s.144 Obligation following new herbal monograph Regulated

Review and update herbal medicine registration if a new monograph is publishedAny Person

s.145 Obligation to provide information relating to safety etc Regulated

Report safety information and trial results for herbal medicinesAny Person

s.146 Obligation in relation to product information Regulated

Keep herbal medicine product information up to dateAny Person

s.147 Record-keeping obligations Regulated

Keep records to facilitate herbal product recallsAny Person

s.148 Urgent safety restrictions Regulated

Notify MHRA of urgent safety changes to herbal medicinesAny Person

s.148 Obligation to ensure appropriate and continued supplies Regulated

Ensure continuous supply of traditional herbal medicinal productsAny Person

s.149 Urgent safety restrictions Regulated

Fail to comply with urgent safety restriction duties for traditional herbal registrationsAny Person

s.150 Offences in connection with applications Regulated

Fail to provide accurate information for herbal medicine registrationAny Person
Give false or misleading info in herbal registration applicationsAny Person

s.151 Provision of false or misleading information Regulated

Provide false or misleading information about a traditional herbal productAny Person
Provide false or misleading information in herbal registrationAny Person

s.152 General offence of breach of provision of this Part Regulated

Breach any provision of the Human Medicines RegulationsAny Person
Breach of medicines regulation requirements in this PartAny Person

s.153 Penalties Imprisonment

Breach of medicines regulationsAny Person

s.154 Persons liable Regulated

Employer liability for employee's application offencesEmployer

18 other sections in this Part — procedural and definitional

s.125 Traditional herbal medicinal products

s.126 Licensing authority list as to herbal substances, preparations and combinations for use in traditional herbal medicinal products

s.126 Addition of vitamins or minerals

s.127 Application for grant of traditional herbal registration

s.128 Accompanying material

s.130 Consideration of application

s.132 Validity of traditional herbal registration

s.134 Failure to place on the market etc

s.135 Revocation, variation and suspension of traditional herbal registration

s.136 Revocation by licensing authority: further provisions

s.137 Procedures for revocation, variation or suspension

s.138 Suspension of use etc of traditional herbal medicinal product

s.139 Registrations granted under Chapter 4 of Title III of the 2001 Directive

s.140 Withdrawal of traditional herbal medicinal product from the market

s.155 Defences

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

2 of 3 sections shown

s.156 Article 126a authorisations Regulated

Other duties (1) — Crown / regulator

Licensing authority may grant special authorisations for Northern IrelandStatutory regulator

s.157 Requests from EU member States Regulated

Other duties (1) — Crown / regulator

Licensing authority must share medicine assessment reports with EU member statesLocal authority

1 other section in this Part — procedural and definitional

s.158 Application of these Regulations

Part 9

Borderline products

2 of 8 sections shown

s.161 Written representations procedure Regulated

Other duties (1) — Crown / regulator

Licensing authority must review provisional classification of a productStatutory regulator

s.164 Effect of final determination Prosecution

Stop selling products if the MHRA determines they are medicinesAny Person

Unlimited fine

6 other sections in this Part — procedural and definitional

s.159 Provisional determination

s.160 Challenge to provisional determination

s.162 Oral representations procedure

s.163 Final determination without representations

s.165 Determination in other cases

s.166 Offences relating to borderline products

Part 10

Exceptions to requirement for marketing authorisation etc

6 of 21 sections shown

s.167 EAMS medicinal products: pharmacovigilance Regulated

Monitor and report safety data for EAMS medicinal productsAny Person

s.167 Early Access to Medicines Scheme: data collection Regulated

Obtain informed consent before collecting patient data for EAMS medicinesData Controller

s.170 MM medicinal products: pharmacovigilance requirements Regulated

Maintain records and report side effects for MM medicinal productsAny Person

s.170 POC medicinal products: pharmacovigilance requirements Regulated

Maintain records and report adverse reactions for POC medicinal productsAny Person

s.175 Offences relating to exceptions Regulated

Provide false information or fail record‑keeping for special‑patient medicinesAny Person
Provide false information or fail to keep medicinal product recordsAny Person

s.176 Penalties and supplementary provision about offences Imprisonment

Breach medicines supply exceptions for emergenciesAny Person
Breach regulation 175 exceptions for human medicinesAny Person

15 other sections in this Part — procedural and definitional

s.167 NIMAR supply to Northern Ireland

s.167 List of NIMAR products

s.167 Supply to fulfil special patient needs

s.168 Use of non-prescription medicines in the course of a business

s.169 Mixing of general sale medicinal products

s.170 Record-keeping requirements

s.171 Exempt advanced therapy medicinal products

s.172 Parallel import licences

s.173 Exemption for certain radiopharmaceuticals

s.174 Supply in response to spread of pathogenic agents etc

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

29 of 43 sections shown

s.178 General obligations of the licensing authority Regulated

Other duties (1) — Crown / regulator

Licensing authority must maintain drug safety reporting and public informationStatutory regulator

s.179 Obligation on licensing authority to operate pharmacovigilance system Regulated

Other duties (1) — Crown / regulator

Licensing authority must operate a pharmacovigilance safety systemStatutory regulator

s.180 Obligation on licensing authority to audit pharmacovigilance system Regulated

Other duties (1) — Crown / regulator

Licensing authority must audit its medicines safety monitoring systemsStatutory regulator

s.182 Obligation on holder to operate pharmacovigilance system Regulated

Operate a pharmacovigilance system for monitoring medicine safetyAny Person

s.184 Obligation on holder to audit pharmacovigilance system Regulated

Audit your pharmacovigilance system and manage findingsAny Person

s.185 Recording obligations on the licensing authority Regulated

Other duties (1) — Crown / regulator

Licensing authority must record all reported suspected adverse drug reactionsStatutory regulator

s.186 The licensing authority must collaborate with the World Health Organisation... Regulated

Other duties (1) — Crown / regulator

Licensing authority must share drug safety data with the WHOStatutory regulator

s.186 Reporting obligations on the licensing authority Regulated

Other duties (1) — Crown / regulator

Licensing authority must process and report adverse drug reactionsStatutory regulator

s.187 Recording obligations on holders Imprisonment

Record and centralise reports of suspected adverse drug reactionsAny Person

s.189 Signal detection: licensing authority obligations Regulated

Other duties (1) — Crown / regulator

MHRA must monitor medicine safety data and share risks with the EMAStatutory regulator

s.191 Obligation on holder of a parallel import licence to submit periodic safety update reports Regulated

Submit periodic safety update reports for parallel import licencesLicence Holder

s.191 Obligation on holder to submit periodic safety update reports: general requirements Regulated

Submit Periodic Safety Update Reports (PSURs) for medicinesAny Person

s.193 Harmonisation of PSUR frequency or date of submission Regulated

Vary marketing authorisation after changes to safety report submissionAny Person

s.194 Responding to a single assessment of PSUR under Article 107e of the 2001 Directive Regulated

Apply for variations following a PSUR single assessmentAny Person

s.196 Major safety review by the licensing authority Regulated

Other duties (1) — Crown / regulator

MHRA must conduct and publish results of major safety reviewsStatutory regulator

s.196 Urgent action Regulated

Other duties (1) — Crown / regulator

Licensing authority must notify international bodies of urgent safety actionsStatutory regulator

s.197 EU urgent action procedure Regulated

Apply to vary medicine authorisation following EU urgent safety actionAny Person

s.199 Submission of draft study protocols for required studies Regulated

Submit draft study protocols for required safety studiesAny Person

s.200 Amendment to study protocols for required studies Regulated

Submit substantial amendments to study protocols to the MHRAAny Person

s.202 Follow-up of final study reports Regulated

Apply for a medicine authorisation variation after a final study reportAny Person

s.203 Obligations on licensing authority in relation to national medicines web-portal Regulated

Other duties (1) — Crown / regulator

Licensing authority must maintain and publish a UK medicines web-portalStatutory regulator

s.205 Further obligations in respect of pharmacovigilance activities Regulated

Maintain pharmacovigilance systems for medicinal productsAny Person

s.205 Obligations on holders in relation to public announcements Regulated

Notify regulators before making public safety announcements about medicinesAny Person

s.207 Offences Imprisonment

Fail to comply with any requirement of the Human Medicines RegulationsAny Person
Fail to comply with pharmacovigilance obligationsAny Person

s.208 False and misleading information Regulated

Provide false or misleading information to medicines regulatorsAny Person
Provide false or misleading information to the licensing authorityAny Person

s.210 Offences in relation to pharmacovigilance obligations under the Implementing Regulation and Schedule 12A Imprisonment

Fail to comply with medicine safety monitoring obligationsAny Person
Fail to meet pharmacovigilance obligationsAny Person

s.210 Offences relating to pharmacovigilance obligations under Regulation (EC) No 726/2004 Regulated

Fail to comply with pharmacovigilance obligations under EU RegulationAny Person

s.211 Persons liable Regulated

Employer liability for employee's medicine offencesEmployer

s.licensing authority power in relation to medicinal Licensing authority power in relation to medicinal products subject to additional monitoring Regulated

Include additional monitoring symbol and statement on product labels if your medicine is on the listManufacturer

14 other sections in this Part — procedural and definitional

s.177 Application of this Part and interpretation

s.181 Delegation of obligations under this Part

s.183 Exception to obligation to operate risk management system

s.188 Reporting obligations on holders

s.190 Signal detection: holder obligation

s.192 Obligation on holder to submit periodic safety update reports: derogation from general requirements

s.195 Obligation on licensing authority to assess PSURs ...

s.198 Post-authorisation safety studies: general provisions

s.201 Submission and evaluation of final study reports for required studies

s.204 Obligation on licensing authority in relation to public announcements

s.206 Infringement notices

s.209 Penalties

s.212 Transitional arrangements

s.guidance in respect of good pharmacovigilance prac Guidance in respect of good pharmacovigilance practice and post authorisation efficacy studies

Part 12

Dealings with medicinal products

12 of 60 sections shown

s.214 Sale or supply of prescription only medicines Imprisonment

Sell prescription‑only medicines without a prescriptionAny Person

s.215 Prescribing and administration by supplementary prescribers Regulated

Only prescribe or administer medicines under a clinical management planEmployee

s.220 Sale or supply of medicinal products not subject to general sale Imprisonment

Sell medicinal product not authorised for general saleAny Person

s.221 Sale or supply of medicinal products subject to general sale Regulated

Sell general sale medicines outside pharmacy without meeting conditionsAny Person
Sell or supply general‑sale medicinal product outside a registered pharmacyAny Person

s.222 Assembly or part-assembly as part of “hub and spoke” dispensing arrangements between different businesses Regulated

Establish written hub-and-spoke dispensing arrangements and notify patientsTrader

s.222 Sale of medicinal products from automatic machines Regulated

Sell medicinal products from automatic machines without general sale authorisationAny Person

s.249 Restrictions on persons to be supplied with medicinal products Regulated

Sell prescription-only or pharmacy medicines to unauthorised personsAny Person

s.251 Compliance with standards specified in certain publications Prosecution

Sell medicinal product that fails to meet monograph standardAny Person
Sell or supply non-compliant named medicinal productsAny Person

Unlimited fine

s.253 Pharmacy records Regulated

Keep records of prescription-only medicine sales and suppliesTrader

s.254 Prohibitions concerning traceability of treatment with advanced therapy medicinal products Regulated

Treat patient with advanced therapy product without traceability systemAny Person

s.255 Offences relating to dealings with medicinal products Prosecution

Breach rules on selling, prescribing, or supplying medicinesAny Person
Illegally sell or supply prescription medicinesAny Person

Unlimited fine

s.256 Disqualification on conviction Prosecution

Use pharmacy premises while disqualifiedAny Person

Unlimited fine

48 other sections in this Part — procedural and definitional

s.213 Interpretation

s.216 Exceptions to regulation 215

s.217 Requirements for prescriptions to be dispensed in an EEA state ...

s.217 Original pack dispensing: medicinal products containing a relevant substance

s.217 Requirements for prescriptions: general

s.218 Requirements for prescriptions: approved country health professional

s.219 Electronic prescriptions

s.223 Exemptions for doctors and dentists etc

s.224 Emergency sale etc by pharmacist: prescriber unable to provide prescription

s.225 Emergency sale etc by pharmacist: at patient's request

s.226 Emergency sale etc by pharmacist: pandemic diseases

s.227 Exemption for sale or supply in hospitals

s.228 Exemptions relating to prescriptions given by certain health professionals

s.229 Exemption for supply by national health service bodies and local authorities

s.230 Exemption for supply etc under a PGD to assist doctors or dentists

s.231 Exemption for supply etc under a PGD by independent hospitals etc

s.232 Exemption for supply etc under a PGD by dental practices and clinics: England and Wales

s.233 Exemption for supply etc under a PGD by person conducting a retail pharmacy business

s.234 Exemption for supply etc of products under a PGD to assist the police etc

s.235 Exemption for sale, supply or administration by certain persons

s.235 Exemption for supply or administration of certain medicines used for vaccination

s.236 Products consisting of or containing aloxiprin, aspirin or paracetamol

s.237 Products consisting of or containing pseudoephedrine salts or ephedrine base or salts

s.237 Appropriate suppliers of naloxone products

s.238 Administration of certain medicines in an emergency

s.239 Administration of smallpox vaccine

s.240 Radioactive medicinal products

s.241 Exemptions in respect of certain herbal remedies

s.242 Exemption for medicinal products at high dilution

s.243 Exemption for certain homoeopathic medicinal products

s.244 Exemption in cases involving another's default

s.245 Exemption in case of forged prescription

s.246 Exemption where requirements for prescriptions not met

s.247 Exemption for supply in the event or anticipation of pandemic disease

s.248 Exemption for certain collection and delivery arrangements

s.250 Exceptions to regulation 249

s.252 Compliance with standards specified in certain publications: supplementary

s.255 Offences relating to Commission Regulation 2016/161: management of the repository system

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 12

Sale of medicines to the public at a distance

8 of 15 sections shown

s.256 Procedure for listing persons who may supply medicinal products at a distance Regulated

Other duties (1) — Crown / regulator

Licensing authority must decide on distance selling list applicationsStatutory regulator

s.256 Provision of information to the licensing authority Imprisonment

Report falsified medicines and changes to your register entryAny Person

s.256 Grant or refusal to list a person Regulated

Other duties (1) — Crown / regulator

Licensing authority must process applications and publish listing detailsStatutory regulator

s.256 Conditions to be met by a person entered on the list Regulated

Display required links and logo for online medicine salesAny Person

s.256 Procedure where the licensing authority proposes to suspend, vary or remove a person’s entry on the list Regulated

Other duties (1) — Crown / regulator

Licensing authority must follow set procedures to change or remove a listingStatutory regulator

s.256 Variation of a person’s entry on the list on the application of that person Regulated

Other duties (1) — Crown / regulator

Licensing authority must decide on entry variations within 30 daysStatutory regulator

s.256 Offences: breach of regulations and false information Imprisonment

Breach of medicines distance selling or false information rulesAny Person
Breach of medicines regulations or give false informationAny Person

s.notification requirements for sellers of medicinal Notification requirements for sellers of medicinal products at a distance Regulated

Notify licensing authority before selling medicines onlineAny Person

7 other sections in this Part — procedural and definitional

s.256 Interpretation

s.256 Removal of a person’s entry from the list

s.256 Suspension of a person’s entry on the list in cases of urgency

s.256 Penalties

s.application of part Application of Part

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

19 of 30 sections shown

s.257 Packaging requirements: variation in accordance with regulation 68(11I) Regulated

Other duties (1) — Crown / regulator

MHRA may require specific packaging statements for Great Britain medicinesStatutory regulator

s.257 Packaging requirements: advanced therapy medicinal products Regulated

Label and package advanced therapy medicinal products correctlyManufacturer

s.257 Packaging requirements: POC medicinal products Imprisonment

Ensure correct labelling on POC medicinal product packagingManufacturer

s.257 Packaging requirements: general Imprisonment

Label and package medicinal products correctlyAny Person

s.259 Packaging requirements: information for blind and partially sighted patients Imprisonment

Provide medicine names in Braille and leaflets in accessible formatsManufacturer

s.260 Package leaflets Regulated

Provide a clear and compliant package leaflet for medicinal productsApplicant

s.261 Use of pictures and symbols etc Regulated

Ensure packaging and leaflets do not contain promotional materialManufacturer

s.262 Labelling requirements for radionuclides Imprisonment

Follow specific labelling requirements for radioactive medicinesManufacturer

s.263 Leaflets relating to radionuclides Regulated

Other duties (1) — Crown / regulator

MHRA must ensure radionuclides include detailed instruction leafletsStatutory regulator

s.264 Homoeopathic medicines Regulated

Ensure homoeopathic medicines are correctly labelled and packagedManufacturer

s.266 Language requirements etc Imprisonment

Use English for medicinal product information and packagingManufacturer

s.267 Submission of mock-ups of packaging and leaflets to licensing authority Regulated

Submit medicine packaging mock-ups and leaflets for approvalAny Person

s.268 Offence relating to packaging and package leaflets in Northern Ireland: holder of authorisation etc Imprisonment

Fail to provide compliant packaging or leaflets for medicines in NIAny Person
Sell or supply medicines in NI with incorrect packaging or leafletsAny Person

s.268 Offence relating to packaging and package leaflets in Great Britain : holder of authorisation etc Regulated

Sell medicinal product with non‑compliant packaging or leafletAny Person
Supply medicines with non-compliant packaging or leafletAny Person

s.269 Offences relating to packaging and package leaflets in Northern Ireland: other persons Imprisonment

Sell medicinal product with non‑compliant packaging or leaflet in NIAny Person
Sell or supply medicines with incorrect packaging or leaflets in Northern IrelandAny Person

s.269 Offences relating to packaging and package leaflets in Great Britain : other persons Regulated

Sell medicinal product with non‑compliant packaging or leaf‑letAny Person
Supply medicine with faulty packaging or missing leafletAny Person

s.270 Non-compliance with requirements of this Part Regulated

Fail to comply with medicines regulator improvement noticeAny Person
Fail to comply with MHRA compliance noticeAny Person

s.273 Child resistant containers for regulated medicinal products Regulated

Use child-resistant and opaque packaging for regulated medicinesTrader

s.276 Offences Imprisonment

Sell medicinal product in improper container or prohibited aspirin/paracetamolAny Person
Sell medicines in wrong packaging or banned children's painkillersAny Person

11 other sections in this Part — procedural and definitional

s.258 Packaging requirements: specific provisions

s.265 Additional requirements for traditional herbal medicinal products

s.271 Offences: penalties

s.272 Interpretation

s.274 Exemptions from regulation 273

s.275 Colouring of aspirin and paracetamol products for children

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

19 of 42 sections shown

s.279 Products without a marketing authorisation etc Regulated

Advertise medicinal product without marketing authorisationAny Person
Publish unauthorised medicinal product advertisementAny Person

s.280 General principles Regulated

Ensure all medicines advertising is accurate, objective, and approvedAny Person

s.281 Duties of authorisation holders and registration holders Regulated

Establish a scientific service and maintain advertising recordsAny Person

s.283 Products for the purpose of inducing abortions Prosecution

Publish advertisement for abortion-inducing productsAny Person
Publish advertisement likely to promote abortion medicationAny Person

Unlimited fine

s.284 Medicines with differing classification status in Great Britain and Northern Ireland Regulated

Include regional availability statements in medicine advertisementsTrader

s.286 Material relating to diagnosis Prosecution

Publish misleading diagnosis-related medical adsAny Person
Publish prohibited medicinal product advertisementAny Person

Unlimited fine

s.288 Material about status of medicinal product Prosecution

Publish misleading advertisement for a medicinal productAny Person
Publish misleading medicinal product advertisementAny Person

Unlimited fine

s.290 Advertisements directed at children Regulated

Advertise medicinal products to childrenAny Person
Publish medicinal product advertisement directed at childrenAny Person

s.293 Prohibition of supply to the public for promotional purposes Prosecution

Supply medicines to the public for promotional purposesAny Person

Unlimited fine

s.295 Abbreviated advertisements Regulated

Ensure abbreviated medicine ads include required safety info and websiteAny Person

s.298 Free samples for persons qualified to prescribe or supply medicinal products Regulated

Meet strict conditions before supplying free medicine samplesDistributor

s.301 Advertisements for registered homoeopathic medicinal products Imprisonment

Restrict content of advertisements for registered homeopathic productsAny Person

s.302 Advertisements for traditional herbal medicinal products Regulated

Include specific wording in advertisements for traditional herbal medicinesAny Person

s.304 Requirement to provide copy advertisement Regulated

Provide copies of medicinal product advertisements to Ministers upon requestAny Person

s.306 Decision about compatibility Regulated

Other duties (1) — Crown / regulator

Ministers must issue a final decision on medicine advertisement compatibilityCrown / Minister / Government department

s.307 Corrective statement Regulated

Publish a corrective statement if your medicine advertisement is ruled illegalAny Person

s.308 Offences Prosecution

Fail to comply with MHRA notice or corrective requirementAny Person
Fail to comply with regulatory notice or corrective statement requirementAny Person

Unlimited fine

s.309 Complaints to Ministers: duty to consider Regulated

Other duties (1) — Crown / regulator

Ministers must consider complaints about illegal medicine advertisementsCrown / Minister / Government department

s.313 Grant of injunction: publication of decision and corrective statement Regulated

Publish court decisions and corrective statements if orderedAny Person

23 other sections in this Part — procedural and definitional

s.277 Interpretation

s.278 Functions of the Ministers

s.282 Application of regulations 283 to 292

s.284 Prescription only medicines

s.285 Narcotic and psychotropic substances

s.287 Material about effects of medicinal product

s.289 Recommendations by scientists etc

s.291 Campaigns relating to the suspected or confirmed spread of pathogenic agents etc.

s.291 Form and content of advertisement

s.292 Exception for approved vaccination campaigns

s.294 General requirements

s.296 Exception for advertisements intended as a reminder

s.297 Written material accompanying promotions

s.299 Medical sales representatives

s.300 Inducements and hospitality

s.303 Offences

s.305 Invitation to make representations about compatibility

s.310 Complaints to Ministers: power to refer

s.311 Application for injunction

s.312 Application for injunction: accuracy of factual claim

s.314 Complaints to OFCOM

s.315 Public interest etc

s.316 Civil proceedings

Part 15

British Pharmacopoeia

2 of 5 sections shown

s.318 Lists of names Regulated

Other duties (1) — Crown / regulator

Government must publish official lists of approved medicine namesCrown / Minister / Government department

s.319 Other documents Regulated

Other duties (1) — Crown / regulator

BPC must prepare and Ministers may publish documents on medicinesStatutory regulator

3 other sections in this Part — procedural and definitional

s.317 British Pharmacopoeia and compendia

s.320 Supplementary provisions

s.321 Specified publications

Part 16

Enforcement

5 of 14 sections shown

s.324 Enforcement in Northern Ireland Regulated

Other duties (1) — Crown / regulator

Minister for Health must enforce medicines regulations in Northern IrelandCrown / Minister / Government department

s.328 Regulation 327: supplementary Regulated

Other duties (1) — Crown / regulator

Regulators must provide ID and notify owners when seizing itemsStatutory regulator

s.329 Application of sampling procedure to substance or article seized under this Part Regulated

Other duties (1) — Crown / regulator

Inspector must provide a sample of seized medicines upon requestStatutory regulator

s.331 Findings and reports of inspections Regulated

Other duties (1) — Crown / regulator

Regulators must report on inspection findings and allow business commentsStatutory regulator

s.334 Supplementary provisions and offences Prosecution

Obstruct an inspector, give false information, or unlawfully disclose informationAny Person
Obstruct inspector or refuse to comply/assistAny Person

Unlimited fine

9 other sections in this Part — procedural and definitional

s.322 Validity of decisions and proceedings

s.323 Enforcement in England, Wales and Scotland

s.325 Rights of entry

s.326 Application for warrant

s.327 Powers of inspection, sampling and seizure

s.330 Analysis of samples: other cases

s.332 Restrictions on disclosure of information

s.333 Protection for inspectors

s.guidelines on inspections Guidelines on inspections

Part 17

Miscellaneous and general

7 of 20 sections shown

s.337 Offences in relation to warranties and certificates Imprisonment

Apply false warranty or certificate to a medicineAny Person
Misuse of warranties or certificates for medicinesAny Person

s.338 Offences by bodies corporate and partnerships Imprisonment

Personal liability for directors and officers in medicines offencesDirector or Officer

s.341 Decisions under these Regulations Regulated

Other duties (1) — Crown / regulator

Licensing authority must provide reasons and appeal info for decisionsStatutory regulator

s.342 Time limits for provision of information etc Regulated

Provide information or assistance within the regulator's specified deadlineAny Person

s.344 Payment of expenses by Ministers Regulated

Other duties (1) — Crown / regulator

Government must pay enforcement expenses to regulatorsCrown / Minister / Government department

s.345 Obligation on licensing authority to maintain list of medicinal products to which derogations have applied Regulated

Other duties (1) — Crown / regulator

Licensing authority must maintain and update list of medicine exemptionsStatutory regulator

s.346 Review Regulated

Other duties (1) — Crown / regulator

Secretary of State must review medicines regulations every five yearsCrown / Minister / Government department

13 other sections in this Part — procedural and definitional

s.335 Contravention due to fault of another person

s.336 Warranty as defence

s.339 Prosecutions

s.340 Presumptions

s.343 Service of documents

s.344 Regulation making powers

s.345 Immunity from civil liability

s.347 Transitional provisions and savings

s.348 Amendments to existing law

s.349 Repeals and revocations

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

234 of 846 shown

s.003 Applications for licences under Part 3 Regulated

Submit detailed information when applying for a manufacturer's licenceApplicant

s.004 Standard provisions of licences under Part 3 Imprisonment

Comply with standard manufacturer's licence conditionsLicence Holder

s.012 Material to accompany an application for a traditional herbal registration Regulated

Submit required information for traditional herbal registrationApplicant

s.015 Requirements for specific products subject to general sale Regulated

Limit pack sizes for aspirin, paracetamol, and ibuprofen on general saleTrader

s.028 Labelling requirements for registrable homoeopathic medicinal products Imprisonment

Follow specific labelling requirements for homeopathic medicinesManufacturer

s.029 Labelling of traditional herbal medicinal products Regulated

Label traditional herbal medicinal products with required safety statementsAny Person

s.sch001 The following medicinal products shall be available only from a... Regulated

Ensure certain medicines are sold only through a pharmacyAny Person

s.sch001 The following medicinal products shall be available only from a... Regulated

Sell listed medicines only from a pharmacy unless authorised for general saleDistributor

s.sch002 The Ministers must provide each advisory body with such staff,... Regulated

Other duties (1) — Crown / regulator

Ministers must provide advisory bodies with resources to operateCrown / Minister / Government department

s.sch004 Where the manufacturer's licence relates to the assembly of a... Regulated

Inform customers about missing product labelling detailsLicence Holder

s.sch004 Where— (a) the manufacturer's licence relates to the assembly of... Regulated

Notify MHRA of changes to manufacturer or importer detailsLicence Holder

s.sch004 The licence holder must keep readily available for examination by... Regulated

Keep records of intermediate products used to make biological medicinesLicence Holder

s.sch004 Where— (a) animals are used in the production of medicinal... Regulated

House and manage production animals to match authorisation provisionsManufacturer

s.sch004 The licence holder must take all reasonable precautions and exercise... Regulated

Ensure accuracy of information provided to the licensing authorityLicence Holder

s.sch004 A licence holder— (a) in Great Britain may only supply... Regulated

Ensure cross-border special medicinal product orders comply with regulation 167Licence Holder

s.sch004 A licence holder may only manufacture or assemble EAMS medicinal... Regulated

Only manufacture EAMS medicines for the Early Access to Medicines SchemeLicence Holder

s.sch004 The licence holder must maintain an MM master file for... Regulated

Maintain an MM master file for each licensed MM medicinal productLicence Holder

s.sch004 An MM master file must contain, as a minimum, the... Regulated

Record required manufacturing and assembly details in the MM master fileLicence Holder

s.sch004 The licence holder must ensure that the information contained in... Regulated

Keep MM master file up to date and consistent with marketing authorisationLicence Holder

s.sch004 The licence holder must make the MM master file available... Regulated

Make MM master file available to licensing authority on requestLicence Holder

s.sch004 The licence holder must submit to the licensing authority, at... Regulated

Submit annual updates to your MM master fileLicence Holder

s.sch004 The licence holder must keep under review the arrangements for... Regulated

Keep your manufacturing supervision arrangements under reviewLicence Holder

s.sch004 (1) The licence holder must record all suspected adverse reactions... Regulated

Record and report suspected adverse reactions to MM medicinal productLicence Holder

s.sch004 The licence holder must maintain a POC master file for... Regulated

Maintain a POC master file for each POC medicinal productLicence Holder

s.sch004 A POC master file must contain, as a minimum, the... Regulated

Ensure POC master file contains all required informationLicence Holder

s.sch004 The licence holder must ensure that the information contained in... Regulated

Keep POC master file information up to date and consistent with marketing authorisationLicence Holder

s.sch004 The licence holder must make the POC master file available... Regulated

Make POC master file available to the licensing authority on requestLicence Holder

s.sch004 The licence holder must submit to the licensing authority, at... Regulated

Submit annual POC master file updates to the licensing authorityLicence Holder

s.sch004 The licence holder must keep under review the arrangements for... Regulated

Review and maintain adequate supervision and control at POC sitesLicence Holder

s.sch004 (1) The licence holder must record all suspected adverse reactions... Regulated

Record and report suspected adverse reactions for POC medicinal productsLicence Holder

s.sch004 The licence holder must place the quality control system referred... Regulated

Place quality control system under a notified qualified personLicence Holder

s.sch004 The licence holder must provide such information as may be... Regulated

Provide import information to the licensing authority on requestLicence Holder

s.sch004 The licence holder must— (a) keep readily available for inspection... Regulated

Keep batch documentation available for inspection and allow copiesLicence Holder

s.sch004 The licence holder must place the quality control system referred... Regulated

Place quality control system under authority of notified personLicence Holder

s.sch004 Where the licence holder has been informed by the licensing... Regulated

Withhold non-conforming batches from distribution when directedLicence Holder

s.sch004 The licence holder must ensure that any tests for determining... Regulated

Test ingredients from finished medicinal product or at approved earlier stageLicence Holder

s.sch004 (1) Where and in so far as the licence relates... Regulated

Give 28 days' notice before importing special medicinal productsLicence Holder

s.sch004 The licence holder must take all reasonable precautions and exercise... Regulated

Ensure information provided to licensing authority is not false or misleadingLicence Holder

s.sch004 A licence holder— (a) in Great Britain may only supply... Regulated

Supply special medicinal products between GB and NI only on valid ordersLicence Holder

s.sch004 A licence holder may only import EAMS medicinal products if... Regulated

Import EAMS products only when needed for the schemeLicence Holder

s.sch004 The licence holder in Great Britain must take all reasonable... Regulated

Don't provide false or misleading information to the medicines regulatorLicence Holder

s.sch004 The licence holder must ensure that the immediate packaging of... Regulated

Label immediate packaging of exempt advanced therapy medicinal products correctlyLicence Holder

s.sch004 The licence holder must ensure that the package leaflet of... Regulated

Include all required particulars in the package leafletLicence Holder

s.sch004 The licence holder must keep the data referred to in... Regulated

Keep clinical trial data for the period set by the licensing authority (over 30 years)Licence Holder

s.sch004 The licence holder must not use any premises for the... Regulated

Only use licensed or approved premises for medicines handling and storageLicence Holder

s.sch004 The licence holder must provide such information as may be... Regulated

Provide information about medicines you handle, store or distributeLicence Holder

s.sch004 The licence holder must take all reasonable precautions and exercise... Regulated

Ensure information provided to the licensing authority is not false or misleadingLicence Holder

s.sch004 Where and in so far as the licence relates to... Regulated

Only import special medicinal products from approved countries under strict conditionsLicence Holder

s.sch004 A licence holder may only import EAMS medicinal products if... Regulated

Import EAMS medicines only when required for the schemeLicence Holder

s.sch004 No later than 28 days prior to each importation of... Regulated

Notify MHRA at least 28 days before importing a special medicinal productLicence Holder

s.sch004 Where the licence holder sells or supplies special medicinal products... Regulated

Record batch numbers and adverse reactions for special medicinesLicence Holder

s.sch004 The licence holder must not, on any one occasion, import... Regulated

Limit the quantity of special medicinal products imported per occasionLicence Holder

s.sch004 The licence holder must inform the licensing authority immediately of... Regulated

Notify the MHRA immediately if an imported medicine becomes unsafeLicence Holder

s.sch004 The licence holder must provide such information as may be... Regulated

Provide information about your manufacturing activities when requested by the licensing authorityLicence Holder

s.sch004 The licence holder must not publish any advertisement, catalogue, or... Regulated

Do not advertise special or EAMS medicinal productsLicence Holder

s.sch004 The licence holder must cease importing or supplying a special... Regulated

Cease importing or supplying special/EAMS products upon written notice from licensing authorityLicence Holder

s.sch004 A licence holder— (a) in Great Britain may only supply... Regulated

Only supply special medicinal products across GB-NI border with a compliant orderLicence Holder

s.sch004 The licence holder shall keep the data referred to in... Regulated

Retain data for over 30 years as specified by licensing authorityLicence Holder

s.sch004 The licence holder must inform the licensing authority of any... Regulated

Notify MHRA of changes to key personnelLicence Holder

s.sch004 The licence holder must— (a) keep readily available for inspection... Regulated

Keep batch documentation available for inspection by licensing authorityLicence Holder

s.sch004 The licence holder must keep readily available for examination by... Regulated

Keep batch samples of finished medicinal products available for inspectionLicence Holder

s.sch004 Where the licence holder has been informed by the licensing... Regulated

Withhold non-conforming batch from distribution when directedLicence Holder

s.sch004 The licence holder must ensure that tests for determining conformity... Regulated

Test medicinal product samples after manufacturing is completeLicence Holder

s.sch005 (1) The licensing authority must— (a) appoint a panel of... Regulated

Other duties (1) — Crown / regulator

Licensing authority must appoint a review panel and provide hearing opportunityStatutory regulator

s.sch005 (1) The applicant must supply the reviewers with a written... Regulated

Submit written summary of oral representations and supporting documents within 3 monthsApplicant

s.sch005 (1) After the hearing the reviewers must provide a report... Regulated

Other duties (1) — Crown / regulator

Licensing authority must decide and notify applicant within 60 days of hearing reportStatutory regulator

s.sch006 The licence holder must secure that the data referred to... Regulated

Arrange data access with a manufacturer’s licence holder if your licence endsLicence Holder

s.sch006 The licence holder must, where an exempt advanced therapy medicinal... Regulated

Ensure traceability system meets requirements for human cells and tissuesLicence Holder

s.sch006 The licence holder must not import or export any exempt... Regulated

Do not import or export exempt advanced therapy medicinal productsLicence Holder

s.sch006 The licence holder must obtain supplies of exempt advanced therapy... Regulated

Obtain exempt advanced therapy medicinal products only from licensed suppliersLicence Holder

s.sch006 The licence holder must distribute an exempt advanced therapy medicinal... Regulated

Distribute exempt therapy products only to authorised recipientsLicence Holder

s.sch006 The licence holder must establish and maintain a system ensuring... Regulated

Set up a traceability system for advanced therapy medicinal productsLicence Holder

s.sch006 The licence holder must inform the licensing authority of any... Regulated

Report adverse reactions to exempt advanced therapy medicinesLicence Holder

s.sch006 The licence holder must, subject to paragraph 44 of Schedule... Regulated

Keep product data for 30 years after medicine expiryLicence Holder

s.sch006 The licence holder must secure that the data referred to... Regulated

Ensure medicine data stays available if your licence endsLicence Holder

s.sch006 The licence holder must inform the licensing authority of any... Regulated

Report adverse reactions to medicines to the MHRA within 15 daysLicence Holder

s.sch006 The licence holder must not import or export any exempt... Regulated

Do not import or export exempt advanced therapy medicinal productsLicence Holder

s.sch006 The licence holder must ensure, if using human cells or... Regulated

Ensure human cell/tissue donation, procurement and testing follows legal requirementsLicence Holder

s.sch006 The licence holder must ensure that any human tissue or... Regulated

Ensure imported human tissue/cells meet equivalent quality and safety standardsLicence Holder

s.sch006 The licence holder must ensure that any blood or blood... Regulated

Ensure imported blood meets UK quality and safety standardsLicence Holder

s.sch006 Where the holder of a manufacturer's licence distributes by way... Regulated

Follow EU good distribution practice for exempt advanced therapy productsManufacturer

s.sch006 The licence holder must, at the written request of the... Regulated

Set up a risk management system when the licensing authority asks in writingLicence Holder

s.sch006 The licence holder must establish and maintain a system ensuring... Regulated

Set up a traceability system for advanced therapy medicinal productsLicence Holder

s.sch006 The licence holder must, subject to paragraph 27 of Schedule... Regulated

Keep exempt advanced therapy product data for 30 years after expiryLicence Holder

s.sch007a Information to be provided for registration as an importer, manufacturer or distributor of active substances Regulated

Provide required information when registering to handle active substancesManufacturer

s.sch007a A statement as to whether the particular active substances are... Regulated

State in registration whether active substances are for special medicinal products or exportAny Person

s.sch007a The address of any premises not mentioned by virtue of... Regulated

Provide address of premises for keeping living animals or animal materialsApplicant

s.sch007a The name, address, qualifications and experience of the person whose... Regulated

Provide responsible person's details for manufacturing authorisationApplicant

s.sch008 A summary of the applicant's pharmacovigilance system which shall include... Regulated

Include pharmacovigilance system details in marketing authorization applicationApplicant

s.sch008 Where an authorisation for the medicinal product to be placed... Regulated

Provide foreign authorisation and safety data with your applicationApplicant

s.sch008 Where an authorisation for the medicinal product to be placed... Regulated

Declare any previous refusal of a marketing authorisation in your applicationApplicant

s.sch008 In the case of a medicinal product for sale or... Regulated

Keep orphan designation and Agency opinion for NI product salesAny Person

s.sch008 For medicinal products included on the list referred to— Regulated

Display additional monitoring symbol on medicinal productsManufacturer

s.sch008 In the case of an advanced therapy medicinal product for... Regulated

Include description of cells/tissues origin in product summary for advanced therapy medicinesManufacturer

s.sch008a Material to accompany an application for a parallel import licence Regulated

Submit required documents for a parallel import licence applicationApplicant

s.sch008a Details of the product to be imported if requested by... Regulated

Provide details of imported product to licensing authority on requestManufacturer

s.sch008a If requested by the licensing authority, an evaluation of the... Regulated

Provide environmental risk evaluation if requestedApplicant

s.sch008a If requested by the licensing authority, a summary of the... Regulated

Provide pharmacovigilance system summary if requestedApplicant

s.sch008a If requested by the licensing authority, the risk management plan,... Regulated

Provide risk management plan and summary when requestedApplicant

s.sch008a If requested by the licensing authority, a summary of the... Regulated

Provide summary of product characteristics if licensing authority requestsApplicant

s.sch009 The manufacturer must provide and maintain such staff, premises and... Regulated

Provide and maintain adequate staff, premises and plant for medicine manufactureManufacturer

s.sch009 The manufacturer must keep readily available for examination by a... Regulated

Keep samples of batches and starting materials for inspectionManufacturer

s.sch009 (1) The manufacturer must implement a system for recording and... Regulated

Set up a complaints and recall system for medicinal productsManufacturer

s.sch009 The manufacturer must inform the holder of the UK marketing... Regulated

Notify marketing authorisation holder of material changes to facilities, equipment, operations, and arrangementsManufacturer

s.sch009 The manufacturer must provide and maintain such staff, premises, equipment... Regulated

Provide and maintain staff, premises, equipment and facilities to prevent medicine deteriorationManufacturer

s.sch009 The manufacturer must provide and maintain a designated quality control... Regulated

Set up an independent quality control departmentManufacturer

s.sch009 The manufacturer must conduct all manufacture and assembly operations in... Regulated

Manufacture medicines to the approved quality, strength and purity standardsManufacturer

s.sch009 The manufacturer must maintain an effective pharmaceutical quality assurance system... Regulated

Maintain an effective pharmaceutical quality assurance systemManufacturer

s.sch009 Where animals are used in the production of any medicinal... Regulated

House and manage animals in compliance with marketing authorisationManufacturer

s.sch009 The manufacturer must make such adequate and suitable arrangements as... Regulated

Test your medicines for strength, quality and purity as per your licenceManufacturer

s.sch009 The manufacturer must inform the holder of the UK marketing... Regulated

Inform marketing authorisation holder of changes to premises, plant, or key personnelManufacturer

s.sch009 (1) The manufacturer shall keep readily available for inspection by... Regulated

Keep durable batch records of manufacture and testsManufacturer

s.sch010a Measures to close the procedures specified in paragraphs 6 to 8 Regulated

Other duties (1) — Crown / regulator

Regulator must tell you if your variation is accepted or rejectedStatutory regulator

s.sch010a Continuous monitoring Regulated

Send variation implementation information without delay when the licensing authority asksAny Person

s.sch010a Licensing authority recommendation on unclassified variations Regulated

Request a recommendation on unclassified variations from the MHRAManufacturer

s.sch010a Variations leading to the revision of product information Regulated

Other duties (1) — Crown / regulator

Licensing authority must consider revised product information as part of variationStatutory regulator

s.sch010a Grouping of variations Regulated

Submit each medicine variation separately unless you qualify for groupingManufacturer

s.sch010a Elements to be submitted Regulated

Include required details in medicines variation applications/notificationsApplicant

s.sch011 (1) After receiving the appropriate committee's report under paragraph 7... Regulated

Other duties (1) — Crown / regulator

Licensing authority must decide on marketing authorisation applications and notify the applicantStatutory regulator

s.sch011 (1) This paragraph applies if the appropriate committee has not... Regulated

Other duties (1) — Crown / regulator

Licensing authority must notify applicants of non-safety related decisionsCrown / Minister / Government department

s.sch011 (1) A person to whom a notification is given under... Regulated

Respond to MHRA notification within 28 days (oral review or written representations)Any Person

s.sch011 Opportunity to make representations Regulated

Other duties (1) — Crown / regulator

Licensing authority must notify applicant of proposed decision and allow representationsStatutory regulator

s.sch011 Written representations Regulated

Submit written representations within 28 daysApplicant

s.sch011 Oral representations Regulated

Provide written summary of oral representations within 28 days of requestApplicant

s.sch011 Other decisions of the appropriate committee Regulated

Other duties (1) — Crown / regulator

Committee must notify licensing authority if applicant fails to make representationsStatutory regulator

s.sch011 Decision of licensing authority Regulated

Other duties (1) — Crown / regulator

Licensing authority must decide on proposed decision and notify applicantStatutory regulator

s.sch011 (1) If the applicant requests the opportunity to make written... Regulated

Submit written representations and documents within deadline after requesting the opportunityApplicant

s.sch011 (1) If the applicant requests the opportunity to make oral... Regulated

Submit written summary and documents to committee for oral hearing requestApplicant

s.sch011 (1) This paragraph applies if the applicant— Regulated

Other duties (1) — Crown / regulator

Appropriate committee must notify licensing authority of applicant’s failure to make representationsStatutory regulator

s.sch011 (1) After receiving the appropriate committee's report under paragraph 19... Regulated

Other duties (1) — Crown / regulator

MHRA must confirm or alter decision after committee report and notify applicantStatutory regulator

s.sch011 (1) The licensing authority must notify the applicant of the... Regulated

Request representations within 28 days of proposal notificationApplicant

s.sch011 (1) If the applicant requests the opportunity to make written... Regulated

Submit written representations within the deadline if you appeal a licence decisionApplicant

s.sch011 (1) If the applicant requests the opportunity to make oral... Regulated

Provide written summary and documents if you request an oral hearingApplicant

s.sch011 (1) This paragraph applies if the applicant— Regulated

Other duties (1) — Crown / regulator

Appropriate committee must notify licensing authority if applicant fails to make representationsStatutory regulator

s.sch011 (1) After receiving the appropriate committee's report under paragraph 26... Regulated

Other duties (1) — Crown / regulator

Licensing authority must decide medicinal product applications and notify applicantsStatutory regulator

s.sch011 (1) If the appropriate committee is consulted under paragraph 2(1)... Regulated

Other duties (1) — Crown / regulator

Appropriate committee must notify you of provisional opinion in writingStatutory regulator

s.sch011 (1) If the applicant or holder requests the opportunity to... Regulated

Submit written representations within 6 months (or shorter deadline set by committee)Applicant

s.sch011 (1) If the applicant or holder requests the opportunity to... Regulated

Provide written summary of oral representations within 6 months of requestApplicant

s.sch011 (1) This paragraph applies if the applicant or holder— Regulated

Other duties (1) — Crown / regulator

Appropriate committee must notify the licensing authority when a hearing is missedStatutory regulator

s.sch012a Further provision as to the performance of pharmacovigilance activities Regulated

Maintain and update a Pharmacovigilance System Master File (PSMF)Any Person

s.sch012a Management of human resources Regulated

Manage human resources for pharmacovigilance activitiesEmployer

s.sch012a Management of human resources Regulated

Other duties (1) — Crown / regulator

Licensing authority must ensure competent personnel and training for pharmacovigilanceStatutory regulator

s.sch012a Compliance management Regulated

Other duties (1) — Crown / regulator

Licensing authority must establish pharmacovigilance procedures and processesStatutory regulator

s.sch012a Individual case safety reports Regulated

Report adverse reactions using individual case safety reports (ICSRs)Manufacturer

s.sch012a Content of the pharmacovigilance system master file Regulated

Keep a pharmacovigilance system master file with the required contentManufacturer

s.sch012a Content of the individual case safety report Regulated

Submit complete and accurate individual case safety reports to the MHRAManufacturer

s.sch012a Format of electronic transmission of suspected adverse reactions Regulated

Report suspected adverse reactions in specified electronic formatManufacturer

s.sch012a Summary of the risk management plan Regulated

Provide a public summary of your risk management plan for each medicineManufacturer

s.sch012a Updates of the risk management plan Regulated

Submit updated risk management plan to the licensing authorityAny Person

s.sch012a Format of the risk management plan Regulated

Ensure risk management plan follows prescribed formatManufacturer

s.sch012a Content of periodic safety update reports Regulated

Prepare and submit periodic safety update reports for your medicinal productsManufacturer

s.sch012a Obligations as to post-authorisation safety studies Regulated

Properly manage post-authorisation safety studies (submit and store data)Manufacturer

s.sch012a Content of the Annex to the pharmacovigilance system master file Regulated

Keep pharmacovigilance master file annex up to dateManufacturer

s.sch012a Format of the study protocol Regulated

Submit non-interventional safety study protocol in required formatManufacturer

s.sch012a Format of the abstract of the final study report Regulated

Submit your final study abstract in the required formatAny Person

s.sch012a Maintenance of the pharmacovigilance system master file Regulated

Keep pharmacovigilance system master file up to date with version controlAny Person

s.sch012a Form of the documents contained in the pharmacovigilance system master file Regulated

Keep pharmacovigilance system master file documents complete, legible, and retrievableAny Person

s.sch012a Availability and location of the pharmacovigilance system master file Regulated

Ensure permanent access to the pharmacovigilance system master file (PSMF) for qualified personsManufacturer

s.sch012a Quality system Regulated

Establish and use a quality system for pharmacovigilance activitiesManufacturer

s.sch024 The number of the UK marketing authorisation, ... Article 126a... Regulated

Include marketing authorisation number on product labelManufacturer

s.sch024 The name of the holder of the UK marketing authorisation,... Regulated

Include your name as holder on medicine product labellingAny Person

s.sch024 Where the product contains tissues and cells of human or... Regulated

State on the label if medicine contains human or animal cells or tissuesManufacturer

s.sch024 The method of use, application, administration or implantation and, if... Regulated

Include method of use and dose space on medicine labelsManufacturer

s.sch024 A special warning that the product is to be stored... Regulated

Include child-safety storage warning on medicine labelsAny Person

s.sch024 Any special warning necessary for the particular product. Regulated

Include any special warning on the product labelAny Person

s.sch024 The name and address of the holder of the UK... Regulated

Show marketing authorisation holder's name and address on medicine labellingManufacturer

s.sch024 Where the exempt advanced therapy medicinal product is for autologous... Regulated

Label exempt ATMPs with patient ID and 'for autologous use only'Manufacturer

s.sch024 Where appropriate, whether the product is intended for babies, children... Regulated

State intended age group (babies, children or adults) in medicine product informationAny Person

s.sch024 The pharmaceutical form and the contents by weight, by volume... Regulated

Include pharmaceutical form and quantity on product labelManufacturer

s.sch024 A list of— (a) where the product is injectable or... Regulated

List excipients on medicinal product labelsAny Person

s.sch024 A list of— (a) where the product is injectable or... Regulated

Include excipient list on medicine labels/leafletsManufacturer

s.sch024 Where appropriate, whether the product is intended for babies, children... Regulated

Include age group indication on product labelling when appropriateManufacturer

s.sch024 Where the product contains up to three active substances, the... Regulated

Show common name of each active substance on medicine product infoManufacturer

s.sch027 Where the product is authorised for sale or supply in... Regulated

List authorised product names for each member state in the package leafletManufacturer

s.sch027 For medicinal products included in the list referred to in... Regulated

Add black-triangle monitoring warning on qualifying medicinal productsAny Person

s.sch027 The therapeutic group, or type of activity, of the product,... Regulated

Include therapeutic group/type of activity in patient informationManufacturer

s.sch027 Where the product contains cells or tissues, a description of... Regulated

Provide description of cells/tissues and origin in product applicationApplicant

s.sch027 The product's therapeutic indications. Regulated

Include therapeutic indications in the patient information leafletManufacturer

s.sch027 A list of information which is necessary before the medicinal... Regulated

Include required safety information in medicinal product literatureManufacturer

s.sch027 The list mentioned in paragraph 25 must— Regulated

Include required information in patient information leafletManufacturer

s.sch027 Instructions for proper use of the product including in particular—... Regulated

Provide full proper-use instructions with medicinesAny Person

s.sch027 A reference to the expiry date printed on the packaging... Regulated

Include required warnings and composition in medicine package leafletManufacturer

s.sch027 The list mentioned in paragraph 7 must— Regulated

Cover special users, driving effects and key excipients in patient leafletManufacturer

s.sch030 The entries or a succinct statement of the entries (if... Regulated

Include adverse reaction, dosage and method details in advertsAny Person

s.sch031 Unless the sampling officer decides not to submit the sample... Regulated

Other duties (1) — Crown / regulator

Sampling officers must retain and submit medicine samples for testingStatutory regulator

s.sch031 (1) This paragraph applies where the sampling officer has obtained... Regulated

Other duties (1) — Crown / regulator

Sampling officer must notify UK manufacturer within 3 daysStatutory regulator

s.sch031 Where the enforcing authority that authorises the sampling officer is... Regulated

Other duties (1) — Crown / regulator

Sampling officers must send samples for analysis to designated medicine laboratoriesCrown / Minister / Government department

s.sch031 Where any other enforcing authority authorises the sampling officer, if... Regulated

Other duties (1) — Crown / regulator

Sampling officer must use approved laboratories for sample analysisStatutory regulator

s.sch031 A laboratory to which a sample is submitted under paragraph... Regulated

Analyse or examine enforcement samples without delayAny Person

s.sch031 A laboratory that has analysed or examined a sample submitted... Regulated

Send certificate of analysis results to the sampling officerAny Person

s.sch031 The sampling officer must as soon as practicable— Regulated

Other duties (1) — Crown / regulator

Sampling officers must divide, mark, seal and handle samples properlyStatutory regulator

s.sch031 (1) If, in proceedings before a magistrates' court for an... Regulated

Notify the other side if relying on a certificate or certifier as a witnessAny Person

s.sch031 (1) Where a sampling officer takes a sample in the... Regulated

Other duties (1) — Crown / regulator

Sampling officer must pay for samples taken when requiredStatutory regulator

s.sch031 If the sample was purchased by the sampling officer otherwise... Regulated

Other duties (1) — Crown / regulator

Sampling officers must give sellers one part of purchased samplesStatutory regulator

s.sch031 If the sampling officer obtained the sample from a vending... Regulated

Other duties (1) — Crown / regulator

Sampling officer must give vending machine owner part of sampleStatutory regulator

s.sch031 If the sample is a sample of goods consigned from... Regulated

Other duties (1) — Crown / regulator

Sampling officer must give one part of sample to consigneeStatutory regulator

s.sch031 If, in a case not falling within any of paragraphs... Regulated

Provide adequate first-aid equipment and facilitiesEmployer

s.sch031 If, in a case not falling within any of paragraphs... Regulated

Other duties (1) — Crown / regulator

Sampling officer must supply sample part to consignorStatutory regulator

s.sch031 In any case not falling within any of paragraphs 3... Regulated

Other duties (1) — Crown / regulator

Sampling officer must supply sample part to ownerStatutory regulator

s.sch031 In every case falling within any of paragraphs 3 to... Regulated

Other duties (1) — Crown / regulator

Sampling officer must tell sample recipient it is for analysisStatutory regulator

s.sch033a Powers of licensing authority in connection with provision of information Regulated

Provide information to licensing authority upon requestAny Person

s.sch033a Variations of converted EU marketing authorisations notified or applied for before IP completion day Regulated

Handle pre-Brexit EU variations of converted marketing authorisations under UK rulesManufacturer

s.sch033a Variations of converted EU marketing authorisations submitted to EMA after IP completion day but before the data submission date Regulated

Tell MHRA about EU variation notifications for converted marketing authorisationsAny Person

s.sch033a Variations of converted EU marketing authorisations sought in advance of the data submission date Regulated

Provide product information when requesting an early variation of a converted EU authorisationManufacturer

s.sch033a Applications for renewals of converted EU marketing authorisations made before IP completion day Regulated

Submit renewal application for converted EU marketing authorisation started before IP completion dayManufacturer

s.sch033a Applications for renewals of converted EU marketing authorisations made after IP completion day Regulated

Submit baseline data with renewal application for converted EU marketing authorisationManufacturer

s.sch033a Renewals of converted EU marketing authorisations sought in advance of the data submission date Regulated

Provide specified product information with early renewal applicationsManufacturer

s.sch033a Article 61(3) notifications made before IP completion day in relation to converted EU marketing authorisations Regulated

Notify MHRA of EMA-notified labelling changes for converted EU marketing authorisationsAny Person

s.sch033a Wholesale dealer's licence used to distribute a medicinal product imported from an EEA State before IP completion day Regulated

Notify MHRA within 6 months to continue importing medicines from approved countries after BrexitLicence Holder

s.sch033a Article 61(3) notifications made in relation to converted EU marketing authorisations after IP completion day but before the data submission date Regulated

Notify MHRA of EMA-labelling changes in baseline data and stop if opposedManufacturer

s.sch033a Article 61(3) notifications sought in advance of the data submission date Regulated

Notify MHRA of proposed changes to labelling or package leaflet before data submission dateAny Person

s.sch033a Inclusion of the batch testing condition in relevant UK marketing authorisations, and batch testing of biological medicinal products in the EEA before IP completion day (regulation 60A) Regulated

Understand batch testing conditions for biological medicines after BrexitManufacturer

s.sch033a Approved country for import list on IP completion day (regulation 18A) Regulated

Other duties (1) — Crown / regulator

Licensing authority must publish and maintain an approved‑country list including all EEA states during the transitional periodStatutory regulator

s.sch033a Applications made for a UK marketing authorisation before IP completion day to which Chapter 4 of Title III of the 2001 Directive applied Regulated

Other duties (1) — Crown / regulator

Licensing authority must decide UK marketing authorisation applications within set timelinesStatutory regulator

s.sch033a Transitional provision in respect of Plasma Master Files Regulated

Notify MHRA of Plasma Master File updates and changes from EMAAny Person

s.sch033a Referrals made under Article 31 of the 2001 Directive concerning the suspension, variation or revocation of an EU marketing authorisation or a UK marketing authorisation that have not concluded before IP completion day Regulated

Other duties (1) — Crown / regulator

MHRA must finalise outstanding EU Article 31 referral procedures for UK marketing authorisationsCrown / Minister / Government department

s.sch033a Application or notification made before IP completion day in respect of a variation under Chapter II of Regulation (EC) No 1234/2008 (variations to marketing authorisations granted in accordance with Chapter 4 of the 2001 Directive) Regulated

Other duties (1) — Crown / regulator

MHRA must assess pending variation applications under UK rules post-BrexitStatutory regulator

s.sch033a Qualified persons and approved country for batch testing list on IP completion day (Schedule 7) Regulated

Other duties (1) — Crown / regulator

Licensing authority must publish and maintain batch testing country listStatutory regulator

s.sch033a Place of establishment for holders of certificates of registration established in EEA before IP completion day Regulated

Appoint a UK contact person and notify MHRAAny Person

s.sch033a Applications made for a certificate of registration for a registrable homoeopathic product before IP completion day to which Chapter 4 of Title III of the 2001 Directive applied Regulated

Other duties (1) — Crown / regulator

MHRA must grant or determine pending homoeopathic product applications within specified timelinesStatutory regulator

s.sch033a Referrals made under Article 31 of the 2001 Directive concerning the suspension, variation or revocation of a certificate of registration that have not concluded before IP completion day Regulated

Other duties (1) — Crown / regulator

MHRA must decide on incomplete EU referrals and act on certificatesStatutory regulator

s.sch033a Place of establishment for holders of traditional herbal registrations established in EEA before IP completion day Regulated

Notify MHRA of a UK-based contact person for your traditional herbal registrationAny Person

s.sch033a List of countries with equivalent regulatory standards as to the manufacturing of active substances on IP completion day (regulation 45O(6) to (9)) Regulated

Other duties (1) — Crown / regulator

MHRA must publish list of equivalent countries for active substance importStatutory regulator

s.sch033a List of approved countries for traditional use of a herbal medicinal product on IP completion day Regulated

Other duties (1) — Crown / regulator

Licensing authority must keep EEA states on approved countries list for traditional herbal medicines during transitional periodCrown / Minister / Government department

s.sch033a Applications made for a traditional herbal registration before IP completion day to which Chapter 4 of Title III of the 2001 Directive applied Regulated

Other duties (1) — Crown / regulator

Licensing authority must decide pending traditional herbal registration applications quicklyStatutory regulator

s.sch033a Referrals made under Article 31 of the 2001 Directive concerning the suspension, variation or revocation of a traditional herbal registration that have not concluded before IP completion day Regulated

Other duties (1) — Crown / regulator

Licensing authority must finalise outstanding Article 31 referrals for traditional herbal registrationsStatutory regulator

s.sch033a Proposals to refer an application for a traditional herbal registration to the Committee for Herbal Medicinal Products and the procedure in Part 3 of Schedule 11 that were on-going at IP completion day Regulated

Other duties (1) — Crown / regulator

MHRA must decide pending traditional herbal registration applications after Brexit dayStatutory regulator

s.sch033a Referrals made under Article 107i of the 2001 Directive concerning the evaluation of data from pharmacovigilance activities which are not concluded before IP completion day Regulated

Other duties (1) — Crown / regulator

Licensing authority must decide unfinished EU pharmacovigilance referrals for UK medicinesCrown / Minister / Government department

s.sch033a Matters on-going at IP completion day in respect of periodic safety update reports Regulated

Provide further information to MHRA if requested during ongoing PSUR assessmentAny Person

s.sch033a Matters on-going at IP completion day in relation to draft study protocols under Article 107n and 107o of the 2001 Directive (submission of, and amendment to, draft study protocols for required studies) Regulated

Provide MHRA requested information on ongoing study protocolsAny Person

s.sch033a Matters on-going at IP completion day in respect of the follow up of final study reports Regulated

Complete follow-up steps for pending final study reports after IP completion dayAny Person

s.sch033a Classification of converted EU marketing authorisations Regulated

Holders of converted EU marketing authorisations must ensure medicines are prescription-onlyAny Person

s.sch033a Obligations of holders of converted EU marketing authorisations Regulated

Submit baseline data for converted EU marketing authorisationsManufacturer

s.sch034 In section 123(1)(b) (offences in relation to warranties and certificates... Prosecution

Give a false warranty or certificate of analysisAny Person

Unlimited fine

612 other schedules

s.001 Further provisions for classification of medicinal products

s.002 Supplementary provision relating to advisory bodies and expert advisory groups

s.008 Material to accompany an application for a UK marketing authorisation

s.010 National homoeopathic products

s.sch001 The following medicinal products shall be available only on prescription—...

s.sch001 In this Part “cyanogenic substances” means preparations which—

s.sch001 A medicinal product shall be available only from a pharmacy...

s.sch002 (1) The person appointed to chair an advisory body is...

s.sch002 If an action is brought against a person arising out...

s.sch002 Paragraphs 8 to 10 shall have effect in relation to...

s.sch002 An advisory body or expert advisory group is not to...

s.sch002 (1) A member of an advisory body, other than its...

s.sch002 (1) The person appointed to chair an expert advisory group...

s.sch002 (1) This paragraph applies to a member of an expert...

s.sch002 The validity of any proceedings of an advisory body or...

s.sch002 (1) An advisory body may, subject to approval by the...

s.sch002 The Ministers may pay to the members of each advisory...

s.sch002 The Ministers must defray any expenses incurred with their approval...

s.sch002a Modifications of Commission Directive 2003/94/EC

s.sch003 (1) This paragraph applies to an application for a manufacturer's...

s.sch003 (1) This paragraph applies to an application for a manufacturer’s...

s.sch003 (1) This paragraph applies to an application for a manufacturer's...

s.sch003 (1) This paragraph applies to an application for a wholesale...

s.sch003 (1) If an application does not include information or other...

s.sch004 The provisions of this Part are standard provisions of a...

s.sch004 The provisions of paragraphs 14D to 14K are incorporated as...

s.sch004 An MM master file may relate to one MM medicinal...

s.sch004 The provisions of paragraphs 14M to 14T are incorporated as...

s.sch004 A POC master file may relate to one POC medicinal...

s.sch004 The provisions of this Part are standard provisions of a...

s.sch004 The licence holder may use a contract laboratory pursuant to...

s.sch004 The provisions of paragraphs 25 to 27 are incorporated as...

s.sch004 The provisions of this Part are standard provisions of a...

s.sch004 The licence holder may use a contract laboratory pursuant to...

s.sch004 The provisions of paragraphs 33 to 42 are incorporated as...

s.sch004 The licence holder may not import the special medicinal product...

s.sch004 The licence holder may import the special medicinal product referred...

s.sch004 In this Part— “British approved name” means the name which...

s.sch004 The provisions of paragraph 44 are incorporated as additional standard...

s.sch005 (1) This Schedule applies if a person (“the applicant”) mentioned...

s.sch005 (1) Both the applicant and the licensing authority may make...

s.sch006 The requirements in paragraphs 2 to 12 apply to a...

s.sch006 The requirements in paragraphs 14 to 20 apply to a...

s.sch007 A person must satisfy the requirements in paragraphs 2 and...

s.sch007 (1) This paragraph applies to a person who—

s.sch007 If a person to whom paragraph 10 applies acquired the...

s.sch007 (1) In Great Britain, the qualified person is responsible for...

s.sch007 (1) In Northern Ireland, the qualified person is responsible for...

s.sch007 In the case of an MM medicinal product or a...

s.sch007 (1) This paragraph applies in Northern Ireland where—

s.sch007 (1) This paragraph applies where— (a) medicinal products are imported...

s.sch007 (1) The qualified person is responsible for ensuring, in relation...

s.sch007 The person must have a degree, diploma or other formal...

s.sch007 A qualification satisfies the requirements of this Part if it...

s.sch007 (1) A course should include at least the following core...

s.sch007 If the course referred to in paragraph 3 is followed...

s.sch007 If two university courses, or courses recognised as of university...

s.sch007 If the person's formal qualifications do not satisfy the requirements...

s.sch007 (1) The person must (subject to sub-paragraph (2)) have at...

s.sch007 (1) This paragraph applies to a person who has acted...

s.sch007a The name and address of the applicant.

s.sch007a The name, address and qualifications of the person to be...

s.sch007a For each active substance to be manufactured, imported, or distributed—...

s.sch007a Details of the operations to which the registration relates, including...

s.sch007a A statement of the facilities and equipment available at each...

s.sch007a A separate statement in respect of each of the premises...

s.sch007a A statement of the authority conferred on the person responsible...

s.sch007a A description of the arrangements for the identification and storage...

s.sch007a The name and address of the person (if any) making...

s.sch007a A description of the arrangements at each of the premises...

s.sch007a A description of the arrangements for maintaining—

s.sch007a A description of the arrangements for keeping reference samples of—...

s.sch007a Where the application relates to active substances intended for use...

s.sch007a Details of— (a) any manufacturing, importation, storage or distribution operations,...

s.sch007a The address of each of the premises where any operations...

s.sch007a The address of each of the premises where active substances...

s.sch007a The address of each of the premises where any testing...

s.sch007a The name, address, qualifications and experience of the person who...

s.sch007a The name, address, qualifications and experience of the person whose...

s.sch008 The name or corporate name and permanent address of the...

s.sch008 The results of the following in relation to the medicinal...

s.sch008 A detailed summary of those results prepared and signed by...

s.sch008 The risk management plan, together with a summary, that—

s.sch008 Where any clinical trials have been carried out outside the...

s.sch008 A summary of the product characteristics for the medicinal product...

s.sch008 (1) Subject to sub-paragraph (2), a mock-up, in accordance with...

s.sch008 A document showing that the manufacturer of the medicinal product...

s.sch008 Where— (a) in the case of a UKMA(NI) or a...

s.sch008 The name of the medicinal product. This may be—

s.sch008 Where , in the case of a medicinal product for...

s.sch008 The name of the medicinal product followed by its strength...

s.sch008 The qualitative and quantitative composition, using the usual common name...

s.sch008 The pharmaceutical form of the medicinal product.

s.sch008 Clinical particulars in relation to the medicinal product, covering—

s.sch008 The pharmacological properties of the medicinal product, covering—

s.sch008 Pharmaceutical particulars in relation to the medicinal product, covering—

s.sch008 Qualitative and quantitative particulars of the constituents of the medicinal...

s.sch008 The holder of the UK marketing authorisation.

s.sch008 The number of the UK marketing authorisation.

s.sch008 The date of the first UK marketing authorisation or, where...

s.sch008 The date of any revisions of the text of the...

s.sch008 For radiopharmaceuticals, full details of internal radiation dosimetry.

s.sch008 For radiopharmaceuticals, additional detailed instructions for extemporaneous preparation and quality...

s.sch008 In the case of an advanced therapy medicinal product for...

s.sch008 An evaluation of the potential environmental risks posed by the...

s.sch008 A description of the methods of manufacturing the medicinal product....

s.sch008 The therapeutic indications and contra-indications for the medicinal product and...

s.sch008 The posology and pharmaceutical form of the medicinal product, its...

s.sch008 The reasons for any precautionary and safety measures to be...

s.sch008 A description of the control methods employed by the manufacturer....

s.sch008 Except in the case of an active substance that contains...

s.sch008a The name or corporate name and permanent address of the...

s.sch008a The name of the medicinal product. This may be—

s.sch008a Details of the UK reference product.

s.sch008a A mock-up, in accordance with Part 13 (packaging and leaflets)...

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.sch008c A copy of the application submitted in connection with the...

s.sch008c A copy of all material submitted in support of the...

s.sch008c A copy of the EU marketing authorisation or UKMA(NI) which...

s.sch009a Meaning of terms used in the orphan criteria and in regulation 58D

s.sch009a Prevalence of a condition in the United Kingdom

s.sch009a Potential for return on investment

s.sch009a Existence of other methods of diagnosis, prevention or treatment

s.sch009a Increased safety or effectiveness and clinical superiority

s.sch009a (1) This paragraph applies for the purposes of the definition...

s.sch010 (1) In this Schedule “national homoeopathic product” means a homoeopathic...

s.sch010 (1) An application for the grant of a UK marketing...

s.sch010 (1) The applicant must submit data as to the safety...

s.sch010 (1) The applicant does not need to submit data as...

s.sch010 (1) The applicant must submit data as to the efficacy...

s.sch010a Variations to a UK marketing authorisation

s.sch010a Interpretation

s.sch010a Extensions of marketing authorisations

s.sch010a Human influenza vaccines

s.sch010a Pandemic situation with respect to human influenza

s.sch010a Urgent safety restrictions

s.sch010a Amendments to the decision granting the marketing authorisation

s.sch010a Implementation of variations

s.sch010a Classification of variations

s.sch010a Notification procedure for minor variations of type IA

s.sch010a Notification procedure for minor variations of type IB

s.sch010a Prior approval procedure for major variations of type II

s.sch011 (1) This Part of this Schedule applies to—

s.sch011 (1) A person to whom a notification is given under...

s.sch011 Application of this Part

s.sch011 Right to review after paragraph 13F notification

s.sch011 This Part applies— (a) to an application (a “Type II...

s.sch011 (1) In paragraph 14(b)(i) “complex variation application” means an application...

s.sch011 (1) In paragraph 14(b)(ii) “new excipient variation application” means an...

s.sch011 In relation to an application for a UKMA(NI) or THR(NI),...

s.sch011 (1) This paragraph applies if the licensing authority notifies the...

s.sch011 (1) The licensing authority must consult the appropriate committee if...

s.sch011 (1) This paragraph applies if the licensing authority notifies the...

s.sch011 (1) This Part applies if the licensing authority proposes to...

s.sch011 (1) Paragraph 2 does not apply to a proposal to...

s.sch011 (1) This paragraph applies if the licensing authority notifies the...

s.sch011 This Schedule does not apply to an application for the...

s.sch011 This Schedule ceases to apply if at any time the...

s.sch011 This Schedule does not apply to an application for a...

s.sch011 This Schedule does not apply if the application or proposal...

s.sch011 This Schedule does not apply if— (a) the licensing authority...

s.sch011 (1) Paragraph 2 does not apply to a proposal to...

s.sch011 (1) An applicant or holder notified under paragraph 5 may,...

s.sch012 The name or corporate name and permanent address of the...

s.sch012 Results of pre-clinical (toxicological and pharmacological) tests in relation to...

s.sch012 A detailed summary of those results prepared and signed by...

s.sch012 A summary of the product characteristics for the medicinal product...

s.sch012 A mock-up, in accordance with Part 13 (packaging and leaflets)...

s.sch012 A document showing that the manufacturer of the medicinal product...

s.sch012 Where the medicinal product consists of a combination of one...

s.sch012 Details of any authorisation or registration obtained by the applicant...

s.sch012 Details of any decision in a country other than the...

s.sch012 Bibliographical or expert evidence of the traditional use of the...

s.sch012 A bibliographic review of safety data.

s.sch012 The name of the medicinal product. This may be—

s.sch012 An expert report on safety.

s.sch012 For medicinal products included on the list referred to in...

s.sch012 The name of the medicinal product followed by its strength...

s.sch012 The qualitative and quantitative composition, using the usual common name...

s.sch012 The pharmaceutical form of the medicinal product.

s.sch012 The pharmacological properties of the medicinal product, covering—

s.sch012 Pharmaceutical particulars of the medicinal product, covering—

s.sch012 The holder of the traditional herbal registration.

s.sch012 The number of the traditional herbal registration.

s.sch012 The date of the first traditional herbal registration or, where...

s.sch012 Qualitative and quantitative particulars of the constituents of the medicinal...

s.sch012 The date of any revisions of the text of the...

s.sch012 An evaluation of the potential environmental risks posed by the...

s.sch012 A description of the methods of manufacturing the medicinal product....

s.sch012 The therapeutic indications and contra-indications for the medicinal product and...

s.sch012 The posology and pharmaceutical form of the medicinal product, its...

s.sch012 The reasons for any precautionary and safety measures to be...

s.sch012 A description of the control methods employed by the manufacturer....

s.sch012a Structure of the pharmacovigilance system master file

s.sch012a Compliance management

s.sch012a Record management and data retention

s.sch012a Audit

s.sch012a Record management and data retention

s.sch012a Audit

s.sch012a Use of internationally agreed terminology, formats and standards

s.sch012a Content of the risk management plan

s.sch012a Format of periodic safety update reports

s.sch012a Scope and interpretation

s.sch012a Format of the final study report

s.sch012a Subcontracting

s.sch012a Performance indicators

s.sch013 Co-danthramer Capsules NPF Co-danthramer Capsules Strong NPF Co-danthramer Oral Suspension...

s.sch014 A clinical management plan must contain the following particulars—

s.sch015 A medicinal product that contains aloxiprin, aspirin or paracetamol (or,...

s.sch015 A medicinal product that contains ibuprofen and that is in...

s.sch016 The period during which the direction is to have effect....

s.sch016 The applicable dosage or maximum dosage.

s.sch016 The route of administration.

s.sch016 The frequency of administration.

s.sch016 Any minimum or maximum period of administration applicable to medicinal...

s.sch016 Whether there are any relevant warnings to note and, if...

s.sch016 Whether there is any follow up action to be taken...

s.sch016 Arrangements for referral for medical advice.

s.sch016 Details of the records to be kept of the supply,...

s.sch016 The description or class of medicinal product to which the...

s.sch016 The clinical situations which medicinal products of that description or...

s.sch016 Whether there are any restrictions on the quantity of medicinal...

s.sch016 The clinical criteria under which a person is to be...

s.sch016 Whether any class of person is excluded from treatment under...

s.sch016 Whether there are circumstances in which further advice should be...

s.sch016 The pharmaceutical form or forms in which medicinal products of...

s.sch016 The strength, or maximum strength, at which medicinal products of...

s.sch018 Ammonium bromide Calcium bromide Calcium bromidolactobionate Embutramide Fencamfamin hydrochloride Fluanisone...

s.sch019 Adrenaline 1:1000 up to 1mg for intramuscular use in anaphylaxis...

s.sch022 Doctors

s.sch022 Dentists

s.sch022 Persons lawfully conducting a retail pharmacy business within the meaning...

s.sch022 Authorities or persons carrying on the business of—

s.sch022 Holders of wholesale dealer's licences or persons to whom the...

s.sch022 Ministers of the Crown and Government departments.

s.sch022 Scottish Ministers.

s.sch022 Welsh Ministers.

s.sch022 A Northern Ireland Minister.

s.sch022 An NHS trust.

s.sch022 An NHS foundation trust.

s.sch022 The Common Services Agency.

s.sch022 A health authority or a special health authority.

s.sch022 A person other than an excepted person who carries on...

s.sch022 In this Schedule “excepted person” means— (a) a doctor or...

s.sch023 Paragraph 2 applies, subject to paragraph 3, where the sale...

s.sch023 In such a case, the particulars referred to in regulation...

s.sch023 Where the sale or supply is in pursuance of a...

s.sch023 Where the sale or supply of a prescription only medicine...

s.sch023 Paragraph 6 applies where— (a) the sale or supply of...

s.sch023 In such a case, the particulars referred to in regulation...

s.sch024 The name of the medicinal product.

s.sch024 A warning that the product must be stored out of...

s.sch024 Any special warning applicable to the product.

s.sch024 The product's expiry date (month and year), in clear terms....

s.sch024 Any special storage precautions relating to the product.

s.sch024 Any special precautions relating to the disposal of an unused...

s.sch024 The name and address of the holder of the UK...

s.sch024 The manufacturer's batch number.

s.sch024 In the case of a product that is not a...

s.sch024 In the case of a medicinal product, other than a...

s.sch024 The words “UK only”.

s.sch024 The name of the medicinal product.

s.sch024 The strength and pharmaceutical form of the product.

s.sch024 Where appropriate, whether the product is intended for babies, children...

s.sch024 Where the product contains up to three active substances, the...

s.sch024 The product's expiry date (month and year), in clear terms....

s.sch024 The manufacturer's batch number.

s.sch024 The name of the medicinal product.

s.sch024 The strength and pharmaceutical form of the product.

s.sch024 Where appropriate, whether the product is intended for babies, children...

s.sch024 Where the product contains up to three active substances, the...

s.sch024 Where appropriate, whether the product is intended for babies, children...

s.sch024 The method of administration of the product and if necessary...

s.sch024 The product's expiry date (month and year), in clear terms....

s.sch024 The manufacturer's batch number.

s.sch024 The contents of the packaging by weight, by volume or...

s.sch024 The name of the advanced therapy medicinal product which is...

s.sch024 Where appropriate, whether the product is intended for babies, children...

s.sch024 The expiry date in clear terms including the year and...

s.sch024 A description of the active substance, expressed qualitatively and quantitatively....

s.sch024 The pharmaceutical form and the contents by weight, volume or...

s.sch024 Where the product contains up to three active substances, the...

s.sch024 A list of excipients, including preservative systems.

s.sch024 Any special storage precautions.

s.sch024 Specific precautions relating to the disposal of the unused product...

s.sch024 The UK marketing authorisation number.

s.sch024 The manufacturer's batch number.

s.sch024 The unique donation code assigned by a tissue establishment pursuant...

s.sch024 A statement of the active substances in the product, expressed...

s.sch024 The information specified in Part 2.

s.sch024 The unique donation code assigned by a tissue establishment pursuant...

s.sch024 Where the exempt advanced therapy medicinal product is for autologous...

s.sch024 The name of the medicinal product.

s.sch024 The strength and pharmaceutical form of the product.

s.sch024 The expiry date, including the year and month and, if...

s.sch024 Where the product contains up to three active substances, the...

s.sch024 A statement of the active substances in the product, expressed...

s.sch024 The pharmaceutical form and the contents by weight, by volume...

s.sch024 The method of administration of the product and if necessary...

s.sch024 Where appropriate, space for the prescribed dose to be indicated....

s.sch024 A warning that the product must be stored out of...

s.sch024 Any special warning applicable to the product.

s.sch024 Any special precautions relating to the disposal of an unused...

s.sch024 The name and address of the holder of the UK...

s.sch024 The number of the UK marketing authorisation for placing the...

s.sch024 The manufacturer’s batch number or other product identifier.

s.sch024 The patient’s name and unique patient identifier.

s.sch024 The name of the medicinal product.

s.sch024 The strength and pharmaceutical form of the product.

s.sch024 The expiry date, including the year and month and, if...

s.sch024 The method of administration of the product and if necessary...

s.sch024 The name of the holder of the UK marketing authorisation...

s.sch024 The manufacturer’s batch number or other product identifier.

s.sch024 The contents of the packaging by weight, by volume or...

s.sch024 The method of administration of the product and if necessary...

s.sch024 The patient’s name and unique patient identifier.

s.sch024 Where appropriate, space for the prescribed dose to be indicated....

s.sch025 Where the product is to be administered to a particular...

s.sch025 Paragraph 11 applies if a pharmacy medicine is—

s.sch025 Where this paragraph applies, the capital letter “P” within a...

s.sch025 Paragraph 13 applies if a prescription only medicine is—

s.sch025 Where this paragraph applies, the capital letters “POM” within a...

s.sch025 If the product contains paracetamol, except where the name of...

s.sch025 If the product contains paracetamol the words “Do not take...

s.sch025 If the product contains paracetamol, unless the product is wholly...

s.sch025 If the product contains paracetamol and is wholly or mainly...

s.sch025 If the product is required by this Part of this...

s.sch025 The name and address of the person who sells or...

s.sch025 The date on which the product is sold or supplied....

s.sch025 Unless paragraph 5, applies, such of the following particulars as...

s.sch025 This paragraph applies if the pharmacist, in the exercise of...

s.sch025 Where paragraph 5 applies, the pharmacist may include such particulars,...

s.sch025 Where a product is to be sold or supplied in...

s.sch025 Any special requirements for the storage and handling of the...

s.sch025 The expiry date of the product.

s.sch025 The manufacturer's batch number.

s.sch026 Where the product is to be administered to a particular...

s.sch026 Where paragraph 9 applies, the pharmacist may include such particulars,...

s.sch026 Where a product is to be sold or supplied in...

s.sch026 Where the product is not prescribed by an appropriate practitioner,...

s.sch026 The name and address of the person who sells or...

s.sch026 The date on which the product is sold or supplied....

s.sch026 Such of the following particulars as the person under whose...

s.sch026 Where a product is to be sold or supplied in...

s.sch026 Where the product is to be administered to a particular...

s.sch026 The name and address of the person who sells or...

s.sch026 The date on which the product is sold or supplied....

s.sch026 Where the product is prescribed by an appropriate practitioner, such...

s.sch026 This paragraph applies if a pharmacist, in the exercise of...

s.sch027 The name of the medicinal product.

s.sch027 A description of the adverse reactions which may occur in...

s.sch027 A reference to the expiry date printed on the packaging...

s.sch027 A standardised text relating to adverse event reporting in accordance...

s.sch027 The date on which the package leaflet was last revised....

s.sch027 If a medicinal product contains paracetamol, unless the product is...

s.sch027 If a medicinal product contains paracetamol and is wholly or...

s.sch027 The name of the advanced therapy medicinal product.

s.sch027 Where appropriate, whether the product is intended for babies, children...

s.sch027 The strength and pharmaceutical form of the product.

s.sch027 The common name of the advanced therapy medicinal product.

s.sch027 Where the product contains medical devices or active implantable medical...

s.sch027 A description of the adverse reactions which may occur in...

s.sch027 Where appropriate, whether the product is intended for babies, children...

s.sch027 The date on which the package leaflet was last revised....

s.sch027 Where the product contains up to three active substances, the...

s.sch027 The pharmaco-therapeutic group, or type of activity, of the product,...

s.sch027 The product's therapeutic indications.

s.sch027 A list of— (a) contra-indications; (b) appropriate precautions for use;...

s.sch027 Instructions for proper use of the product including in particular—...

s.sch028 The scientific name of the stock or stocks (which may...

s.sch028 The number of the certificate of registration.

s.sch028 The words “homoeopathic medicinal product without therapeutic indications”.

s.sch028 A warning advising the user to consult a doctor if...

s.sch028 The scientific name of the stock or stocks (which may...

s.sch028 The name and address of the holder of the certificate...

s.sch028 The product's expiry date (month and year), in clear terms....

s.sch028 The manufacturer's batch number.

s.sch028 The words “homoeopathic medicinal product without therapeutic indications”.

s.sch028 The scientific name of the stock or stocks (which may...

s.sch028 The name and address of the holder of the certificate...

s.sch028 The method and, if necessary, route of administration.

s.sch028 The product's expiry date (month and year), in clear terms....

s.sch028 The contents of the presentation, specified by weight, volume or...

s.sch028 The manufacturer's batch number.

s.sch028 The words “homoeopathic medicinal product without therapeutic indications”.

s.sch028 The method and, if necessary, route of administration.

s.sch028 The product's expiry date (month and year), in clear terms....

s.sch028 The product's pharmaceutical form.

s.sch028 The contents of the presentation, specified by weight, volume or...

s.sch028 Special storage precautions, if any.

s.sch028 A special warning, if necessary in relation to the product....

s.sch028 The manufacturer's batch number.

s.sch029 A statement to the effect that the product is a...

s.sch029 A statement that the user should consult a doctor or...

s.sch029 Subject to the provisions of regulation 265(2), paragraph 4 applies...

s.sch029 Where this paragraph applies, the outer packaging and the immediate...

s.sch030 The number of the UK marketing authorisation , EU marketing...

s.sch030 The name and address of the holder of the temporary...

s.sch030 In relation to an advertisement in Great Britain (other than...

s.sch030 The classification of the medicinal product as—

s.sch030 The name of the medicinal product.

s.sch030 A list of the active ingredients of the medicinal product...

s.sch030 One or more of the indications for the medicinal product...

s.sch030 The cost excluding value added tax of—

s.sch030 (1) The particulars specified in paragraph 7 must be printed...

s.sch031 (1) This Schedule has effect where a person authorised by...

s.sch031 If a sample consists of substances or articles in unopened...

s.sch031 Regulation 343(1)(a) to (d) has effect in relation to supplying...

s.sch031 If after reasonable inquiry the sampling officer is unable to...

s.sch031 (1) Arrangements of the kind mentioned in paragraphs 15(b) and...

s.sch031 A person to whom a part of the sample is...

s.sch031 (1) In proceedings for an offence under these Regulations, a...

s.sch031 In proceedings for an offence under these Regulations, a document...

s.sch031 (1) This paragraph applies where proceedings for an offence under...

s.sch031 The costs of analysis or examination under paragraph 24 are...

s.sch031 (1) In relation to England and Wales section 9 of...

s.sch032 (1) This paragraph applies where any provision of these Regulations...

s.sch032 (1) This paragraph applies to a marketing authorisation that—

s.sch032 (1) This paragraph applies to a product licence of right....

s.sch032 (1) Sub-paragraph (3) applies to a UK marketing authorisation granted...

s.sch032 No provision of these Regulations that applies only to advanced...

s.sch032 Regulation 9 (amendment of the Medicines for Human Use (Clinical...

s.sch032 (1) Section 60 of the Medicines Act 1968 (“the Act”)...

s.sch033 Pharmacovigilance system master file

s.sch033 The reference to “the EMA” in regulations 191(1) (obligation on...

s.sch033 Regulation 210(3)(b) (offences relating to pharmacovigilance obligations under Regulation (...

s.sch033 Post-authorisation safety studies

s.sch033 Regulation 210(3)(g) (offences relating to pharmacovigilance obligations under Regulation (EC)...

s.sch033 Reporting obligations

s.sch033 The references to “the Eudravigilance database” in regulation 188(1)(a) and...

s.sch033 The licensing authority must ensure that all reports and updated...

s.sch033 Regulations 186(1)(e) (reporting obligations on licensing authority in relation to...

s.sch033 Periodic safety update reports

s.sch033a Transitional provision in relation to EU Exit

s.sch033a In this Schedule— “ the COMP ” means the Committee...

s.sch033a Applications for renewals of conditional marketing authorisations made before IP completion day

s.sch033a Applications for renewals of conditional marketing authorisations made after IP completion day

s.sch033a Place of establishment for converted EU marketing authorisation holder established in EEA state before IP completion day

s.sch033a Temporary exemption as to packaging requirements for converted EU marketing authorisations

s.sch033a Referrals made under Article 20 of Regulation (EC) No 726/2004 that have not concluded or been implemented before IP completion day

s.sch033a Enforcement

s.sch033a Place of establishment for UK marketing authorisation holder or parallel import licence holder established in an EEA State before IP completion day

s.sch033a Status of certain UK marketing authorisations granted before IP completion day

s.sch033a Temporary exemption as to packaging requirements: change of place of establishment

s.sch033a Status of parallel import licences granted before IP completion day

s.sch033a Conversion of parallel distribution notices in to parallel import licences

s.sch033a Application of the batch testing requirement to relevant EU marketing authorisations, and batch testing of biological medicinal products in the EEA before IP completion day (regulation 60B)

s.sch033a Existing data and marketing exclusivity and global marketing authorisations

s.sch033a Applications for EU marketing authorisations made before IP completion day

s.sch033a Place of establishment for UK marketing authorisation holder established in EEA state before IP completion day (pre-exit EU marketing authorisation applications)

s.sch033a Packaging in relation to UK marketing authorisations granted in response to application for EU marketing authorisation made before IP completion day

s.sch033a Suspensions of UK marketing authorisations that have effect immediately before IP completion day that were imposed under Chapter 4 of Title III of the 2001 Directive or Regulation (EC) No 726/2004

s.sch033a Application or notification made before IP completion day in respect of a variation under Chapter IIa of Regulation (EC) No 1234/2008 (variations to purely national marketing authorisations)

s.sch033a Application or notification in respect of a variations made before IP completion day under Article 20 of Regulation (EC) No 1234/2008 (work-sharing procedure)

s.sch033a Transitional provision in relation to applications made to EMA before IP completion day under the Paediatric Regulation

s.sch033a Transitional provision in relation to global marketing authorisations under the 2001 Directive

s.sch033a List of countries for the purposes of the definition of “homoeopathic medicinal product” on IP completion day

s.sch033a Temporary exemption as to packaging requirements: change of place of establishment

s.sch033a Suspensions of certificates of registration that have effect immediately before IP completion day that were imposed under Chapter 4 of Title III of the 2001 Directive

s.sch033a Temporary exemption as to packaging requirements: change of place of establishment

s.sch033a Suspensions of traditional herbal registrations that have effect immediately before IP completion day that were imposed under Chapter 4 of Title III of the 2001 Directive

s.sch033a Conversion of EU marketing authorisations in force before IP completion day

s.sch033a Approved country health professional list on IP completion day (regulation 214(6A))

s.sch033a Licensing authority power to require information

s.sch033a Obligations of licensing authority in connection with converted EU marketing authorisations

s.sch033b Transitional Provision in relation to the Windsor Framework

s.sch033b Existing marketing authorisations

s.sch033b Existing applications for marketing authorisation

s.sch033b Post-authorisation processes

s.sch034 The Medicines Act 1968 is amended as follows.

s.sch034 In section 72 (representative of pharmacist in case of death...

s.sch034 (1) The Co-ordination of Regulatory Enforcement (Regulatory Functions in Scotland...

s.sch034 In Schedule 1(3) to the Single Use Carrier Bags Charge...

s.sch034 For regulation 3(2)(b)(i) of the Control of Pesticides Regulations (Northern...

s.sch034 In rule 4 of the Prison and Young Offenders Centre...

s.sch034 In the Schedule to the Diseases of Animals (Importation of...

s.sch034 In Part 2 of Schedule 2 to the Pharmaceutical Services...

s.sch034 In Schedule 1, Chapter 4, Section 4.8, Part C of...

s.sch034 The Products of Animal Origin (Import and Export) Regulations (Northern...

s.sch034 In article 5(a) of the Importation of Animal Pathogens Order...

s.sch034 In Schedule 2 to the Biocidal Products Regulations (Northern Ireland)...

s.sch034 In section 82(4) (pharmacies: procedure relating to disqualification) for “Pharmaceutical...

s.sch034 (1) The Misuse of Drugs Regulations (Northern Ireland) 2002 are...

s.sch034 In regulation 5(2)(c) of the Control of Substances Hazardous to...

s.sch034 In paragraph 2 of Schedule 1 to the Waste Management...

s.sch034 (1) The Health and Personal Social Services (General Medical Services...

s.sch034 In regulation 13(6)(b) of the Nursing Homes Regulations (Northern Ireland)...

s.sch034 In regulation 20(4)(b) of the Children's Homes Regulations (Northern Ireland)...

s.sch034 In regulation 3(1) of the Healthy Start Scheme and Day...

s.sch034 In regulation 71(3)(a) of the Avian Influenza and Influenza of...

s.sch034 In regulation 13(6)(b) of the Day Care Setting Regulations (Northern...

s.sch034 In section 87 (requirements as to containers)—

s.sch034 In regulation 13(4)(b) of the Residential Family Centres Regulations (Northern...

s.sch034 In regulation 3(1)(a) of the Natural Mineral Water, Spring Water...

s.sch034 In article 5(2)(b) of the Specified Animal Pathogens Order (Northern...

s.sch034 In regulation 2(2) of the Controlled Drugs (Supervision of Management...

s.sch034 In regulation 4(b) of the Private Water Supplies Regulations (Northern...

s.sch034 In section 88(1) (distinctive colours, shapes and markings of medicinal...

s.sch034 In section 91 (offences under Part V, and supplementary provisions)—...

s.sch034 In section 104 (application of Act to certain articles and...

s.sch034 In section 105 (application of Act to certain other substances...

s.sch034 In section 107 (validity of decisions and proceedings relating thereto)—...

s.sch034 (1) Section 108 (enforcement in England and Wales) is amended...

s.sch034 In section 109 (enforcement in Scotland)— (a) in subsection (2)—...

s.sch034 For the text of section 1 (Ministers responsible for the...

s.sch034 In section 110 (enforcement in Northern Ireland)—

s.sch034 In section 111 (rights of entry)— (a) in subsection (1)...

s.sch034 In section 113(1) (application of sampling procedure to substance or...

s.sch034 In section 114(1) (supplementary provisions as to rights of entry...

s.sch034 In section 121(4) (contravention due to default of other person),...

s.sch034 In section 122(2) (warranty as defence), for the words “section...

s.sch034 In section 125 (prosecutions)— (a) in subsection (4)—

s.sch034 In section 126 (presumptions)— (a) in subsection (1), omit paragraph...

s.sch034 In section 128 (financial provisions)— (a) in subsection (1), for...

s.sch034 In section 10 (exemptions for pharmacists)— (a) in subsection (1)...

s.sch034 In section 129 (orders and regulations)— (a) in subsection (2),...

s.sch034 In section 130 (meaning of medicinal product and related expressions)—...

s.sch034 In section 131(5) (meaning of “wholesale dealing”, “retail sale” and...

s.sch034 In section 132 (general interpretation provisions)— (a) for subsection (1)...

s.sch034 In Schedule 3 (sampling)— (a) omit paragraphs 5 to 7;...

s.sch034 In Schedule 4 (provisions relating to Northern Ireland)—

s.sch034 (1) The Medicines Act 1971 shall have effect as follows....

s.sch034 In section 2(5)(b) (trade descriptions) of the Trade Descriptions Act...

s.sch034 In Part II (bodies of which all members are disqualified)...

s.sch034 In section 15 (provision for extending or modifying exemptions)—

s.sch034 Section 19(1) (interpretation of Part II) of the Consumer Protection...

s.sch034 In section 142(7) (powers to obtain information about potentially hazardous...

s.sch034 In Part II of Schedule 8 (zero-rating) to the Value...

s.sch034 In section 60(2A)(c) (regulation of health care and associated professions)...

s.sch034 In section 368R(1) (interpretation of Part 4A) of the Communications...

s.sch034 In section 7 (interpretation) of the Christmas Day and New...

s.sch034 The Health and Personal Social Services (Northern Ireland) Order 1972...

s.sch034 In article 2(2) of the Pharmacy (Northern Ireland) Order 1976...

s.sch034 In article 38 of the Diseases of Animals (Northern Ireland)...

s.sch034 In section 58 (medicinal products on prescription only)—

s.sch034 In article 33(6) of the Waste and Contaminated Land (Northern...

s.sch034 In article 4(3) of the Shops (Sunday Trading &c.) (Northern...

s.sch034 The Medicines for Human Use (Clinical Trials) Regulations 2004 are...

s.sch034 In regulation 2(1) (interpretation)— (a) before the definition “the Act”...

s.sch034 In regulation 4(3) (responsibility for functions under the Directive) for...

s.sch034 In regulation 19(10) (authorisation procedure for clinical trials involving medicinal...

s.sch034 In regulation 46(2)(c) (labelling) for words from “Schedule 5” to...

s.sch034 In regulation 47 (application of enforcement provisions of the Act)—...

s.sch034 In regulation 48(5) (infringement notices) for “sections 108 to 110...

s.sch034 In regulation 49(5) (offences) for “the Act” substitute “ the...

s.sch034 In section 58A(1) (requirement to specify certain products as prescription-only...

s.sch034 In regulation 53(3) (construction of references to specified publications) for...

s.sch034 In paragraph 4(2) of Schedule 5 (procedural provisions relating to...

s.sch034 In Schedule 7 (standard provisions for manufacturing authorisations)—

s.sch034 In paragraph 5(2) of Schedule 8 (procedural provisions relating to...

s.sch034 For Schedule 9 substitute the following Schedule— SCHEDULE 9 MODIFICATIONS OF...

s.sch034 In regulation 8(1) of the Medicines (Administration of Radioactive Substances)...

s.sch034 In the Schedule to the Importation of Animal Products and...

s.sch034 In rule 2 of The Medicines Act (Hearings by Persons...

s.sch034 (1) The Medicines (Fixing of Fees Relating to Medicinal Products...

s.sch034 In section 62 (prohibition of sale or supply, or importation,...

s.sch034 In regulation 1(2) of the Medical Devices (Consultation Requirements) (Fees)...

s.sch034 (1) The Prescription Only Medicines (Human Use) Order 1997 is...

s.sch034 In rule 7B(b) of the Schedule to the General Optical...

s.sch034 The National Health Service (Charges for Drugs and Appliances) Regulations...

s.sch034 In Schedule 2 to the Biocidal Products Regulations 2001 —...

s.sch034 In article 4(4) of the Medicines (Aristolochia and Mu Tong...

s.sch034 In regulation 2(1) of the Misuse of Drugs Regulations 2001...

s.sch034 In paragraph (d) of article 3 of the Medicines for...

s.sch034 In article 1(3) of the Medicines and Healthcare Products Regulatory...

s.sch034 In the column “specified UK laws” of the Schedule to...

s.sch034 In section 64(5) (protection for purchasers of medicinal products) for...

s.sch034 In the Schedule to the Enterprise Act 2002 (Part 8...

s.sch034 In article 6 of the Health Professions (Parts of and...

s.sch034 (1) The Unlicensed Medicinal Products for Human Use (Transmissible Spongiform...

s.sch034 (1) The National Health Service (General Medical Services Contracts) (Scotland)...

s.sch034 (1) The National Health Service (Primary Medical Services Section 17C...

s.sch034 (1) The National Health Service (General Medical Services Contracts) Regulations...

s.sch034 (1) The National Health Service (General Medical Services Contracts) (Wales)...

s.sch034 (1) The National Health Service (Personal Medical Services Agreements) Regulations...

s.sch034 In Schedule 2 to the National Health Service (General Medical...

s.sch034 (1) The Contracting Out (Functions relating to Broadcast Advertising) and...

s.sch034 (1) Section 67 (offences under Part III) is amended as...

s.sch034 In the Table in rule 10 of the Schedule to...

s.sch034 (1) The National Health Service (Free Prescriptions and Charges for...

s.sch034 In regulation 2(3) of the Human Tissue (Quality and Safety...

s.sch034 (1) The Schedule to the Legislative and Regulatory Reform (Regulatory...

s.sch034 In paragraph (d) of article 3 of the Medicines for...

s.sch034 In article 5(2) of the Specified Animal Pathogens Order 2008...

s.sch034 In article 5(2) of the Specified Animal Pathogens (Wales) Order...

s.sch034 In regulation 1(2) of the Health Service Branded Medicines (Control...

s.sch034 In article 5(2) of the Specified Animal Pathogens (Scotland) Order...

s.sch034 (1) The National Health Service (Pharmaceutical Services) (Scotland) Regulations 2009...

s.schedule/16/part/4/paragraph/wrapper5n2 Pharmacists. Registered chiropodists and podiatrists. Registered dental hygienist. Registered dental...

s.schedule/21/part/1/paragraph/wrapper8n2 schedule/21/part/1/paragraph/wrapper8n2

s.schedule/21/part/2/paragraph/wrapper9n2 schedule/21/part/2/paragraph/wrapper9n2

s.schedule/21/part/3/paragraph/wrapper10n2 schedule/21/part/3/paragraph/wrapper10n2

s.schedule/21/part/4/paragraph/wrapper138n2 schedule/21/part/4/paragraph/wrapper138n2

Help complying

Guvnor’s practical routes through this instrument.

Run a healthcare business

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How to obtain MHRA authorisation for medicines and medical devices in the UK. Covers Marketing Authorisations, wholesale dealer licences, manufacturer licences, and …

MHRA licensing for medicines and medical devices

MHRA licensing requirements for manufacturing, distributing, and importing medicines and medical devices in the UK.

Medicines and controlled drugs compliance

Legal requirements for handling, storing and administering medicines including controlled drugs in healthcare settings.

9 more guides that reference this instrument

Get authorised to manufacture medicines: MHRA licensing, active-substance registration and GMP Pharmaceutical manufacturer: compliance checklist Run a retail pharmacy or optical business Running clinical trials in the UK Which medicines manufacturing authorisation applies Wholesale licences for controlled and excise goods Healthcare professional registration requirements Specialist retail licences and registrations Start a clinical laboratory service

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

Human Medicines Regulations 2012

Does it bind you?

Other Acts binding the same actors

What it requires

General

Administration

Manufacture and distribution of medicinal products and active substances

Requirement for authorisation

Marketing authorisations

Certification of homoeopathic medicinal products

Traditional herbal registrations

Article 126a authorisations

Borderline products

Exceptions to requirement for marketing authorisation etc

Pharmacovigilance

Dealings with medicinal products

Sale of medicines to the public at a distance

Packaging and leaflets

Advertising

British Pharmacopoeia

Enforcement

Miscellaneous and general

Schedules

Help complying

Run a healthcare business

Healthcare compliance quick check

Start a retail business - compliance essentials

Respond to a medicines or controlled drugs incident

Run a retail business

MHRA authorisation for medicines and medical devices

MHRA licensing for medicines and medical devices

Medicines and controlled drugs compliance