Run a healthcare business
- 5 steps
UK Statutory Instrument
2012
United Kingdom
Human Medicines Regulations 2012
At a glance
Who this Act binds
Business-side actors with duties under this Act, ranked by how often they appear.
- Any Person 169
- Licence Holder 76
- Manufacturer 50
- Applicant 30
- Trader 13
- Employer 5
- Data Controller 1
- Distributor 1
- Employee 1
- Director or Officer 1
Plus 80 non-business duties on Crown ministers, regulators, local authorities or tribunals — shown collapsed under each section below.
Step-by-step journeys using this legislation
Walkthroughs that take you from a real business situation to compliance.
Healthcare compliance quick check
- 2 steps
Start a retail business - compliance essentials
- 1 step
Respond to a medicines or controlled drugs incident
- 1 step
Run a retail business
- 1 step
Relevant guidance
Practical guides for businesses affected by this Act, ordered by how closely they engage with it.
Direct — cites this Act
3 guidesSupporting — topic alignment
6 guidesGet 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
Mentioned in related content
3 guidesOther Acts binding the same actors
For each actor bound by this Act, the other UK Acts that bind them most often. Useful for understanding the full compliance landscape facing each role.
Any Person also bound by 2338 other Acts (top 5 shown)
- Merchant Shipping Act 1995 1995 144 duties
- Insolvency (England and Wales) Rules 2016 2016 101 duties
- Road Traffic Act 1988 1988 95 duties
- Air Navigation Order 2016 2016 95 duties
- Communications Act 2003 2003 89 duties
Licence Holders also bound by 221 other Acts (top 5 shown)
- Petroleum (Current Model Clauses) Order 1999 1999 317 duties
- The Petroleum Licensing (Exploration and Production) (Seaward and Landward Areas) Regulations 2004 2004 123 duties
- Space Industry Regulations 2021 2021 68 duties
- The Petroleum (Production) (Landward Areas) Regulations 1991 1991 65 duties
- The Petroleum Licensing (Exploration and Production) (Landward Areas) Regulations 2014 2014 51 duties
Manufacturers also bound by 472 other Acts (top 5 shown)
- Pressure Equipment (Safety) Regulations 2016 2016 91 duties
- Lifts Regulations 2016 2016 70 duties
- The Ecodesign for Energy-Related Products and Energy Information Regulations 2021 2021 70 duties
- Non-Automatic Weighing Instruments Regulations 2016 2016 67 duties
- Pyrotechnic Articles (Safety) Regulations 2015 2015 64 duties
Applicants also bound by 294 other Acts (top 5 shown)
- Insolvency (England and Wales) Rules 2016 2016 46 duties
- The Land Registration Rules 2003 2003 25 duties
- Value Added Tax Regulations 1995 1995 18 duties
- Space Industry Regulations 2021 2021 14 duties
- Infrastructure Planning (Environmental Impact Assessment) Regulations 2017 2017 10 duties
Traders also bound by 826 other Acts (top 5 shown)
- Value Added Tax Regulations 1995 1995 413 duties
- Companies Act 2006 2006 243 duties
- The Large and Medium-sized Companies and Groups (Accounts and Reports) Regulations 2008 2008 114 duties
- Insolvency (England and Wales) Rules 2016 2016 62 duties
- Building Societies Act 1986 1986 56 duties
Employers also bound by 694 other Acts (top 5 shown)
- The Income Tax (Pay As You Earn) Regulations 2003 2003 236 duties
- Provision and Use of Work Equipment Regulations 1998 1998 120 duties
- TULRCA 1992 1992 72 duties
- Employment Rights (Northern Ireland) Order 1996 (current NI employment law) 1996 52 duties
- Income Tax (Earnings and Pensions) Act 2003 2003 50 duties
Data Controllers also bound by 38 other Acts (top 5 shown)
- UK GDPR (retained EU law) 2016 126 duties
- The Town and Country Planning (Entertainment Resort Complex, Bedford) Special Development (No. 2) Order 2025 2025 50 duties
- Data Protection Act 2018 2018 46 duties
- Regulation (EU) 2018/1139 (EASA Basic Regulation) 2018 6 duties
- Commission Delegated Regulation (EU) No 231/2013 of 19 December 2012 supplementing Directive 2011/61/EU of the European Parliament and of the Council with regard to exemptions, general operating conditions, depositaries, leverage, transparency and supervision (Text with EEA relevance) 2013 5 duties
Distributors also bound by 177 other Acts (top 5 shown)
- The Marketing of Fruit Plant and Propagating Material (England) Regulations 2017 2017 28 duties
- The Marketing of Fruit Plant and Propagating Material (Wales) Regulations 2017 2017 26 duties
- The Marketing of Fruit Plant and Propagating Material Regulations (Northern Ireland) 2017 2017 25 duties
- Electricity Safety, Quality and Continuity Regulations 2002 2002 21 duties
- THE ELECTRICITY SAFETY, QUALITY AND CONTINUITY REGULATIONS (NORTHERN IRELAND) 2012 2012 19 duties
Employees also bound by 182 other Acts (top 5 shown)
- Employment Rights (Northern Ireland) Order 1996 (current NI employment law) 1996 13 duties
- Regulation (EU) No 965/2012 (Air Operations) 2012 12 duties
- Shared Parental Leave Regulations 2014 2014 10 duties
- The Income Tax (Pay As You Earn) Regulations 2003 2003 10 duties
- Paternity and Adoption Leave Regulations 2002 2002 9 duties
Directors and Officers also bound by 425 other Acts (top 5 shown)
- Insolvency (England and Wales) Rules 2016 2016 161 duties
- Companies Act 2006 2006 108 duties
- Insolvency Act 1986 1986 72 duties
- The Large and Medium-sized Companies and Groups (Accounts and Reports) Regulations 2008 2008 55 duties
- The Housing Administration (England and Wales) Rules 2018 2018 26 duties
What this Act requires
Sections that create concrete duties on businesses or carry penalties. Procedural and definitional sections are folded into the “Browse other sections” expander at the bottom of each group. Click any section title to read the source text on legislation.gov.uk.
Part 1 — General
Browse 10 other sections in this Part — procedural / definitional / commencement
Citation and commencement
Medicinal products
Scope of these Regulations: special provisions
Special provisions for pharmacies etc
Classification of medicinal products
The licensing authority and the Ministers
Advertisements relating to medicinal products
General interpretation
Definition of advanced therapy medicinal product etc.
Preparation and assembly of medicinal products used for vaccination or immunisation against coronavirus or in the reformulation of such products
Part 2 — Administration
British Pharmacopoeia Commission
Other duties (1) — Crown / regulator
- Ministers must appoint and maintain the British Pharmacopoeia Commission Crown / Minister / Government department
Appointment of expert advisory groups
Other duties (1) — Crown / regulator
- MHRA and advisory bodies may appoint expert advisory groups Statutory regulator
Browse 6 other sections in this Part — procedural / definitional / commencement
Commission on Human Medicines
Functions of the Commission
Reporting to Ministers
Co-option of additional members of advisory bodies
Delegation of functions to expert advisory groups
Further provision about advisory bodies and expert advisory groups etc
Part 3 — Manufacture and distribution of medicinal products and active substances
Manufacturing of MM medicinal products
2 years imprisonment- Hold a manufacturer's licence and follow a master file for MM products Any Person
Manufacturing of POC medicinal products
2 years imprisonment- Obtain a licence and master file to manufacture POC medicines Any Person
Approved country for import
Other duties (1) — Crown / regulator
- MHRA must maintain and review the approved countries list for medicine imports Statutory regulator
Application for manufacturer's or wholesale dealer's licence
- Apply for a manufacturer's or wholesale dealer's licence Trader
Factors relevant to determination of application for manufacturer's or wholesale dealer's licence
Other duties (1) — Crown / regulator
- Licensing authority must evaluate specific safety and quality criteria Statutory regulator
Effect of suspension or variation relating to modular unit or POC site
- Do not re-approve suspended manufacturing units without a new application Licence Holder
Procedure where licensing authority proposes to suspend, revoke or vary licence
Other duties (1) — Crown / regulator
- Licensing authority must follow specific procedures to change or cancel a licence Statutory regulator
Certification of manufacturer's licence
- Request a certificate of manufacturer's licence for exporting medicines Licence Holder
Offence concerning data for advanced therapy medicinal products
- Fail to keep or transfer ATMP data as required Manufacturer
- Fail to keep or transfer data for advanced therapy medicinal products Manufacturer
Penalties
2 years imprisonment- Breach of regulations on advanced therapy medicinal products or starting materials Any Person
Manufacturing and assembly of MM medicinal products: additional requirements
- Comply with additional manufacturing requirements for MM medicinal products Manufacturer
Manufacturing and assembly
- Comply with medicine manufacturing, sourcing, and quality standards Licence Holder
Imports from states other than EEA States / countries other than approved countries for import
- Ensure medicines and active substances meet import safety standards Licence Holder
Further requirements for manufacturer's licence
2 years imprisonment- Maintain adequate staff and facilities for medicine manufacturing Licence Holder
Requirements as to qualified persons
- Maintain a 'Qualified Person' and notify the MHRA of changes Licence Holder
Obligations of licence holder in Great Britain supplying listed NIMAR products to Northern Ireland
- Maintain supply and standards for NIMAR medicines to Northern Ireland Licence Holder
Obligations of licence holder
- Comply with wholesale distribution standards and supply obligations Licence Holder
Brokering in medicinal products
- Register as a medicine broker and follow distribution guidelines Any Person
Requirement as to responsible persons where licence holder imports from an approved country for import
2 years imprisonment- Appoint a Responsible Person (Import) for medicines from approved countries Licence Holder
Register for responsible persons (import)
Other duties (1) — Crown / regulator
- Licensing authority must maintain a register of import responsible persons Statutory regulator
Application for brokering registration
- Register as a broker of medicinal products Any Person
Procedure for determining an application for broker’s registration
Other duties (1) — Crown / regulator
- Licensing authority must determine broker registration within 90 days Statutory regulator
Grant or refusal of broker’s registration
Other duties (1) — Crown / regulator
- Licensing authority must determine broker applications within 90 days Statutory regulator
Provision of information
- Report falsified medicines and maintain compliance systems Trader
Variation of a broker’s registration on the application of the broker
- Apply in writing to change your broker registration Any Person
Penalties
2 years imprisonment- Breach medicines regulations or provide false information Any Person
- Breach of regulation 45K requirements for human medicines Any Person
Requirements for registration as an importer, manufacturer or distributor of an active substance
2 years imprisonment- Comply with Good Practice standards for active medicinal substances Manufacturer
Variation of an active substance registration on an application from the registered person
- Apply to change your active substance registration Any Person
Requirement as to responsible persons
- Appoint and notify a 'Responsible Person' for your medicines licence Licence Holder
Criteria of broker’s registration
- Maintain ongoing registration criteria as a medicines broker Trader
Browse 36 other sections in this Part — procedural / definitional / commencement
Manufacturing of medicinal products
Wholesale dealing in medicinal products
Exemptions from requirement for wholesale dealer's licence
Mixing of medicines
Grant or refusal of licence
Standard provisions of licences
Duration of licence
General power to suspend, revoke or vary licences
Suspension of licence in cases of urgency
Variation of licence on the application of the holder
Provision of information
Sale and supply of starting materials
Offences: breach of regulations and false information and defence concerning starting materials
Conditions for manufacturer's licence
Manufacturing and assembly of POC medicinal products: additional requirements
Obligation to provide information relating to control methods
Conditions for wholesale dealer's licence
Requirement for wholesale dealers to decommission the unique identifier
Requirement for wholesale dealers to deal only with specified persons
Offences: breach of regulations and false information
Provision of information
Procedure where licensing authority proposes to suspend or vary an active substance registration or remove a person from the active substance register
Suspension of an active substance registration in cases of urgency
Offences: breach of regulations and false information
Penalties
Criteria for importation, manufacture or distribution of active substances
Guidelines on good manufacturing practice and good distribution practice
Interpretation
Power to suspend or vary a broker’s registration or remove a broker from the register
Power to suspend or vary or remove an active substance registration
Procedure where licensing authority proposes to suspend or vary a broker’s registration or remove a broker from the register
Registration in relation to active substances
Regulations on good manufacturing practice
Suspension of a broker registration in cases of urgency
Variation of MM master file
Variation of POC master file
Part 4 — Requirement for authorisation
Breach of requirement
2 years imprisonment- Sell or supply medicines without authorisation Any Person
Browse 1 other section in this Part — procedural / definitional / commencement
Part 5 — Marketing authorisations
Other applications including paediatric indications
- Include safety monitoring details in paediatric medicine applications Applicant
Applications relating to advanced therapy medicinal products
- Provide efficacy and safety follow-up plans for advanced therapy medicines Applicant
Applications relating to conditional marketing authorisations ...
- Demonstrate eligibility for a conditional marketing authorisation Applicant
Applications relating to POC medicinal products
- Provide monitoring plans for Point of Care (POC) medicinal products Applicant
Application for UKMA(NI) relating to generic medicinal products
- Do not sell generic medicines in Northern Ireland before the allowed date Applicant
Application for UKMA(NI) relating to certain medicinal products that do not qualify as generic etc
- Provide specific data when applying for a Northern Ireland Marketing Authorisation Applicant
Application for UKMA(UK) relating to similar biological medicinal products
- Submit supplementary data for similar biological medicine applications Applicant
Application for UKMA(NI) relating to similar biological medicinal products
- Provide additional data for 'biosimilar' medicine applications Applicant
Applications relating to new combinations of active substances
- Submit trial data for new drug combinations Applicant
Obligation to update information supplied in connection with parallel import licence application
- Update the MHRA on parallel import licence information Applicant
Obligation to update information supplied in connection with application
- Update your marketing authorisation application with new information Applicant
Publication of information relating to paediatric marketing authorisations
Other duties (1) — Crown / regulator
- Licensing authority must publish paediatric medicine registers and decisions Statutory regulator
Consideration of applications relating to orphan medicinal products
Other duties (1) — Crown / regulator
- MHRA must grant orphan marketing authorisations and maintain a public list Statutory regulator
Consideration of applications relating to combined advanced therapy medicinal products
Other duties (1) — Crown / regulator
- MHRA must assess and factor in device certificates for combined medicines Statutory regulator
Consideration of applications relating to conditional marketing authorisations
- Include conditional status and renewal date on medicine packaging and leaflets Applicant
Consideration of applications in relation to medicinal products containing or consisting of genetically modified organisms
Other duties (1) — Crown / regulator
- Licensing authority must ensure GMO medicinal products meet safety standards Local authority
Consideration of application
Other duties (1) — Crown / regulator
- Licensing authority must decide on marketing authorisations within 210 days Statutory regulator
Conditions of UK marketing authorisation or parallel import licence : general
- Incorporate licence conditions into your risk management system Manufacturer
Conditions of UK marketing authorisation: new obligations post-authorisation
- Comply with post-authorisation obligations and update risk management system Manufacturer
Classification of UK marketing authorisation or parallel import licence
Other duties (1) — Crown / regulator
- MHRA must classify medicines as prescription-only, pharmacy, or general sale Statutory regulator
Frequency of periodic safety update reports
2 years imprisonmentOther duties (1) — Crown / regulator
- Licensing authority must specify frequency for safety reports in authorisations Local authority
Obligation of licensing authority in case of change of classification
Other duties (1) — Crown / regulator
- MHRA must protect clinical data for new medicine classifications for one year Statutory regulator
Duties of licensing authority in connection with determination
Other duties (1) — Crown / regulator
- MHRA must publish medicine authorisation details and assessment reports Statutory regulator
Application for renewal of authorisation
- Apply to renew your UK marketing authorisation Applicant
Sale etc of suspended medicinal product
2 years imprisonment- Do not sell or supply medicines that have been suspended Any Person
Obligation to notify placing on the market etc
- Notify the MHRA when medicines are marketed or withdrawn Trader
Obligation to provide information relating to methods of manufacture and control: MM medicinal products
- Share manufacturing and control information with the licence holder Any Person
Obligation to provide information relating to methods of manufacture and control: POC medicinal products
- Provide manufacturing and control info to the POC licence holder Manufacturer
Obligation to take account of scientific and technical progress
- Review and update medicine manufacturing methods as science progresses Any Person
Obligation to provide information relating to safety etc
- Report new safety info and trial results for medicines Any Person
Obligation in relation to product information
- Keep medicine product information up to date with scientific knowledge Trader
Record-keeping obligations
- Keep records to facilitate product recalls or withdrawals Any Person
Post authorisation requirements in relation to UKMA(UK)(Category 1) for advanced therapy medicinal products
- Maintain data and traceability for advanced therapy medicinal products Any Person
Obligation to ensure appropriate and continued supplies
- Ensure continuous supply of medicines to the UK market Any Person
Failure to provide information on marketing authorisations to EMA
- Fail to submit marketing authorisation information to EMA Any Person
- Fail to submit required EMA information for marketing authorisations Any Person
Urgent safety restrictions: parallel import licences
2 years imprisonment- Fail to comply with urgent safety restrictions on parallel import licence Any Person
Urgent safety restrictions
- Fail to comply with urgent safety restrictions on medicines Any Person
Offences in connection with withdrawal of product from the market
Unlimited fine- Cease supply of authorised medicine without proper transfer or EMA notice Any Person
- Withdraw a paediatric medicine from the market illegally Any Person
Failure to place on the market taking account of paediatric indication
Unlimited fine- Fail to place paediatric medicine on the market Any Person
- Fail to place product on market with paediatric indication Any Person
Failure to notify results of paediatric study
- Fail to notify paediatric study results Any Person
- Fail to submit paediatric study results on time Any Person
Offences relating to Commission Regulation 2016/161
- Breach Commission Regulation 2016/161 on medicine safety features Any Person
Offences in connection with parallel import licence application
2 years imprisonment- Fail to give accurate information in parallel import licence application Any Person
- Provide false or incomplete information in parallel import licence application Any Person
Offences in connection with application
Unlimited fine- Fail to give truthful information in a marketing authorisation application Any Person
- Give false or incomplete info in a medicine licence application Any Person
Provision of false or misleading information
- Provide false or misleading information about a medicinal product Any Person
- Provide false or misleading information to regulators Any Person
Breach of pharmacovigilance condition
- Breach of pharmacovigilance condition Any Person
- Fail to comply with pharmacovigilance conditions Any Person
General offence of breach of provision of this Part
- Breach any provision of the Human Medicines Regulations Any Person
- Breach of human medicines regulations requirements Any Person
Penalties
2 years imprisonment- Breach human medicines regulations Any Person
- Breach of human medicines regulations and pharmacovigilance duties Any Person
Condition as to the submitting of samples and other information to the appropriate authority
- Submit batch samples of biological medicines for testing before sale Manufacturer
Browse 47 other sections in this Part — procedural / definitional / commencement
Application of this Part
Application for grant of UK marketing authorisation or parallel import licence
Agreement and modification of paediatric investigation plan
Application for paediatric use marketing authorisation
Applications relating to orphan medicinal products
Accompanying material
Applications relating to products in well-established medicinal use
Applications containing information supplied in relation to another product with consent
Conditions of UK marketing authorisation or parallel import licence : exceptional circumstances
Validity of UK marketing authorisation
Renewal of conditional marketing authorisation
Failure to place on the market etc
Revocation, variation and suspension of UK marketing authorisation or parallel import licence
Suspension of use etc of relevant medicinal product
Authorisations granted under Chapter 4 of Title III of the 2001 Directive
Withdrawal of medicinal product from the market
Obligation to update information supplied in connection with EU application
EU marketing authorisations: failure to notify placing on market etc
EU marketing authorisations: failure to take account of technical and scientific progress
EU marketing authorisations: failure to provide information as to safety etc
EU marketing authorisations: failure to update product information
EU marketing authorisations: breach of pharmacovigilance condition etc
Offences in connection with risk management systems and traceability systems
Offence concerning data for advanced therapy medicinal products
Failure to notify results of third country clinical trials
Failure of sponsor of UK paediatric clinical trial to notify results of trial
Failure to submit report to EMA
Persons liable
Defences
Application for renewal of a parallel import licence
Application for UKMA(GB) relating to certain medicinal products that do not qualify as generic etc
Application for UKMA(GB) relating to generic medicinal products
Application for UKMA(GB) relating to similar biological medicinal products
Application for UKMA(UK) relating to certain medicinal products that do not qualify as generic etc.
Application for UKMA(UK) relating to generic medicinal products
Application of regulations 89 to 94
Applications in relation to medicinal products containing or consisting of genetically modified organisms
Deferral of initiation or completion of measures in paediatric investigation plan
Orphan rewards
Paediatric rewards
Post authorisation requirements in relation to UK marketing authorisations to which paediatric specific provisions apply
Requirement for certain applications to include results of paediatric investigation plan
Submitting of samples and other information: EU marketing authorisations
Validity of conditional marketing authorisation
Validity of parallel import licence
Variation of a UKMA(GB) or a UKMA(UK)(Category 1)
Waiver of production of information in a paediatric investigation plan
Part 6 — Certification of homoeopathic medicinal products
Classification of certificate of registration
Other duties (1) — Crown / regulator
- Licensing authority must classify medicine registration certificates Statutory regulator
Application for renewal of certificate
- Apply to renew your homeopathic medicine registration Applicant
Obligation to notify placing on the market etc
- Notify the MHRA of medicine market entry, withdrawals, and sales volumes Any Person
Obligation to take account of scientific and technical progress
- Keep product manufacturing and control methods up to date Manufacturer
Obligation to provide information relating to safety etc
- Report safety updates and risks to the licensing authority Manufacturer
Obligation in relation to product information
- Keep medicine product information up to date with scientific knowledge Any Person
Record-keeping obligation
- Keep records to help with product recalls or withdrawals Any Person
Obligation to ensure appropriate and continued supplies
- Ensure continuous supply of registered medicines to meet patient needs Any Person
Offences in connection with applications
- Fail to give correct information on homoeopathic medicine registration Any Person
- Fail to supply or provide false information in homeopathic product application Any Person
Provision of false or misleading information
2 years imprisonment- Provide false or misleading information to the MHRA Any Person
General offence of breach of provision of this Part
2 years imprisonment- Breach of human medicine registration or licensing requirements Any Person
Penalties
2 years imprisonment- Breach of regulations regarding herbal medicines or misleading information Any Person
- Commit an offence under the Human Medicines Regulations Any Person
Persons liable
- Be liable for employee's offence under regulation 119 Employer
- Employer liable for employee's application offence Employer
Browse 10 other sections in this Part — procedural / definitional / commencement
Application of Part
Application for certificate of registration
Consideration of application
Conditions of certificate of registration
Validity of certificate of registration
Failure to place on the market etc
Revocation, variation and suspension of certificate of registration
Certificates granted under Chapter 4 of Title III of the 2001 Directive
Withdrawal of homoeopathic medicinal product from the market
Defences
Part 7 — Traditional herbal registrations
Obligation to update information supplied in connection with application
- Update herbal medicine registration applications with new safety data Applicant
Procedure where less than 15 years use of traditional herbal medicinal product
Other duties (1) — Crown / regulator
- MHRA may refer traditional herbal medicine applications for expert advice Statutory regulator
Classification of traditional herbal registration
- Categorise traditional herbal products for sale Trader
Application for renewal of registration
- Apply to renew your traditional herbal registration Applicant
Sale etc of suspended traditional herbal medicinal product
2 years imprisonment- Do not sell or supply suspended traditional herbal medicinal products Any Person
Obligation to notify placing on the market etc
- Notify the MHRA when herbal products are launched or withdrawn Any Person
Obligation to take account of scientific and technical progress
- Keep herbal medicine manufacturing methods up to date with scientific progress Trader
Obligation following new herbal monograph
- Review and update herbal medicine registration if a new monograph is published Any Person
Obligation to provide information relating to safety etc
- Report safety information and trial results for herbal medicines Any Person
Obligation in relation to product information
- Keep herbal medicine product information up to date Any Person
Record-keeping obligations
- Keep records to facilitate herbal product recalls Any Person
Urgent safety restrictions
- Notify MHRA of urgent safety changes to herbal medicines Any Person
Obligation to ensure appropriate and continued supplies
- Ensure continuous supply of traditional herbal medicinal products Any Person
Urgent safety restrictions
- Fail to comply with urgent safety restriction duties for traditional herbal registrations Any Person
Offences in connection with applications
- Fail to provide accurate information for herbal medicine registration Any Person
- Give false or misleading info in herbal registration applications Any Person
Provision of false or misleading information
- Provide false or misleading information about a traditional herbal product Any Person
- Provide false or misleading information in herbal registration Any Person
General offence of breach of provision of this Part
- Breach any provision of the Human Medicines Regulations Any Person
- Breach of medicines regulation requirements in this Part Any Person
Penalties
2 years imprisonment- Breach of medicines regulations Any Person
Persons liable
- Employer liability for employee's application offences Employer
Browse 18 other sections in this Part — procedural / definitional / commencement
Traditional herbal medicinal products
Licensing authority list as to herbal substances, preparations and combinations for use in traditional herbal medicinal products
Addition of vitamins or minerals
Application for grant of traditional herbal registration
Accompanying material
Consideration of application
Validity of traditional herbal registration
Failure to place on the market etc
Revocation, variation and suspension of traditional herbal registration
Revocation by licensing authority: further provisions
Procedures for revocation, variation or suspension
Suspension of use etc of traditional herbal medicinal product
Registrations granted under Chapter 4 of Title III of the 2001 Directive
Withdrawal of traditional herbal medicinal product from the market
Defences
Establishment of herbal monographs
Interpretation of this Part
List of approved countries for traditional use of a herbal medicinal product
Part 8 — Article 126a authorisations
Article 126a authorisations
Other duties (1) — Crown / regulator
- Licensing authority may grant special authorisations for Northern Ireland Statutory regulator
Requests from EU member States
Other duties (1) — Crown / regulator
- Licensing authority must share medicine assessment reports with EU member states Local authority
Browse 1 other section in this Part — procedural / definitional / commencement
Part 9 — Borderline products
Written representations procedure
Other duties (1) — Crown / regulator
- Licensing authority must review provisional classification of a product Statutory regulator
Effect of final determination
Unlimited fine- Stop selling products if the MHRA determines they are medicines Any Person
Browse 6 other sections in this Part — procedural / definitional / commencement
Part 10 — Exceptions to requirement for marketing authorisation etc
EAMS medicinal products: pharmacovigilance
- Monitor and report safety data for EAMS medicinal products Any Person
Early Access to Medicines Scheme: data collection
- Obtain informed consent before collecting patient data for EAMS medicines Data Controller
MM medicinal products: pharmacovigilance requirements
- Maintain records and report side effects for MM medicinal products Any Person
POC medicinal products: pharmacovigilance requirements
- Maintain records and report adverse reactions for POC medicinal products Any Person
Offences relating to exceptions
- Provide false information or fail record‑keeping for special‑patient medicines Any Person
- Provide false information or fail to keep medicinal product records Any Person
Penalties and supplementary provision about offences
2 years imprisonment- Breach medicines supply exceptions for emergencies Any Person
- Breach regulation 175 exceptions for human medicines Any Person
Browse 15 other sections in this Part — procedural / definitional / commencement
NIMAR supply to Northern Ireland
List of NIMAR products
Supply to fulfil special patient needs
Use of non-prescription medicines in the course of a business
Mixing of general sale medicinal products
Record-keeping requirements
Exempt advanced therapy medicinal products
Parallel import licences
Exemption for certain radiopharmaceuticals
Supply in response to spread of pathogenic agents etc
Advertising of EAMS medicinal products
Conditions of temporary authorisations under regulation 174
EAMS medicinal products: manufacture, assembly, importation, distribution and supply
EAMS scientific opinions ceasing to have effect
Early Access to Medicines Scheme: establishment and licensing authority functions
Part 11 — Pharmacovigilance
General obligations of the licensing authority
Other duties (1) — Crown / regulator
- Licensing authority must maintain drug safety reporting and public information Statutory regulator
Obligation on licensing authority to operate pharmacovigilance system
Other duties (1) — Crown / regulator
- Licensing authority must operate a pharmacovigilance safety system Statutory regulator
Obligation on licensing authority to audit pharmacovigilance system
Other duties (1) — Crown / regulator
- Licensing authority must audit its medicines safety monitoring systems Statutory regulator
Obligation on holder to operate pharmacovigilance system
- Operate a pharmacovigilance system for monitoring medicine safety Any Person
Obligation on holder to audit pharmacovigilance system
- Audit your pharmacovigilance system and manage findings Any Person
Recording obligations on the licensing authority
Other duties (1) — Crown / regulator
- Licensing authority must record all reported suspected adverse drug reactions Statutory regulator
The licensing authority must collaborate with the World Health Organisation...
Other duties (1) — Crown / regulator
- Licensing authority must share drug safety data with the WHO Statutory regulator
Reporting obligations on the licensing authority
Other duties (1) — Crown / regulator
- Licensing authority must process and report adverse drug reactions Statutory regulator
Recording obligations on holders
2 years imprisonment- Record and centralise reports of suspected adverse drug reactions Any Person
Signal detection: licensing authority obligations
Other duties (1) — Crown / regulator
- MHRA must monitor medicine safety data and share risks with the EMA Statutory regulator
Obligation on holder of a parallel import licence to submit periodic safety update reports
- Submit periodic safety update reports for parallel import licences Trader
Obligation on holder to submit periodic safety update reports: general requirements
- Submit Periodic Safety Update Reports (PSURs) for medicines Any Person
Harmonisation of PSUR frequency or date of submission
- Vary marketing authorisation after changes to safety report submission Any Person
Responding to a single assessment of PSUR under Article 107e of the 2001 Directive
- Apply for variations following a PSUR single assessment Any Person
Major safety review by the licensing authority
Other duties (1) — Crown / regulator
- MHRA must conduct and publish results of major safety reviews Statutory regulator
Urgent action
Other duties (1) — Crown / regulator
- Licensing authority must notify international bodies of urgent safety actions Statutory regulator
EU urgent action procedure
- Apply to vary medicine authorisation following EU urgent safety action Any Person
Submission of draft study protocols for required studies
- Submit draft study protocols for required safety studies Any Person
Amendment to study protocols for required studies
- Submit substantial amendments to study protocols to the MHRA Any Person
Follow-up of final study reports
- Apply for a medicine authorisation variation after a final study report Any Person
Obligations on licensing authority in relation to national medicines web-portal
Other duties (1) — Crown / regulator
- Licensing authority must maintain and publish a UK medicines web-portal Statutory regulator
Further obligations in respect of pharmacovigilance activities
- Maintain pharmacovigilance systems for medicinal products Any Person
Obligations on holders in relation to public announcements
- Notify regulators before making public safety announcements about medicines Any Person
Offences
2 years imprisonment- Fail to comply with any requirement of the Human Medicines Regulations Any Person
- Fail to comply with pharmacovigilance obligations Any Person
False and misleading information
- Provide false or misleading information to medicines regulators Any Person
- Provide false or misleading information to the licensing authority Any Person
Offences in relation to pharmacovigilance obligations under the Implementing Regulation and Schedule 12A
2 years imprisonment- Fail to comply with medicine safety monitoring obligations Any Person
- Fail to meet pharmacovigilance obligations Any Person
Offences relating to pharmacovigilance obligations under Regulation (EC) No 726/2004
- Fail to comply with pharmacovigilance obligations under EU Regulation Any Person
Persons liable
- Employer liability for employee's medicine offences Employer
Licensing authority power in relation to medicinal products subject to additional monitoring
- Include additional monitoring symbol and statement on product labels if your medicine is on the list Manufacturer
Browse 14 other sections in this Part — procedural / definitional / commencement
Application of this Part and interpretation
Delegation of obligations under this Part
Exception to obligation to operate risk management system
Reporting obligations on holders
Signal detection: holder obligation
Obligation on holder to submit periodic safety update reports: derogation from general requirements
Obligation on licensing authority to assess PSURs ...
Post-authorisation safety studies: general provisions
Submission and evaluation of final study reports for required studies
Obligation on licensing authority in relation to public announcements
Infringement notices
Penalties
Transitional arrangements
Guidance in respect of good pharmacovigilance practice and post authorisation efficacy studies
Part 12 — Dealings with medicinal products
Sale or supply of prescription only medicines
2 years imprisonment- Sell prescription‑only medicines without a prescription Any Person
Prescribing and administration by supplementary prescribers
- Only prescribe or administer medicines under a clinical management plan Employee
Sale or supply of medicinal products not subject to general sale
2 years imprisonment- Sell medicinal product not authorised for general sale Any Person
Sale or supply of medicinal products subject to general sale
- Sell general sale medicines outside pharmacy without meeting conditions Any Person
- Sell or supply general‑sale medicinal product outside a registered pharmacy Any Person
Assembly or part-assembly as part of “hub and spoke” dispensing arrangements between different businesses
- Establish written hub-and-spoke dispensing arrangements and notify patients Trader
Sale of medicinal products from automatic machines
- Sell medicinal products from automatic machines without general sale authorisation Any Person
Restrictions on persons to be supplied with medicinal products
- Sell prescription-only or pharmacy medicines to unauthorised persons Any Person
Compliance with standards specified in certain publications
Unlimited fine- Sell medicinal product that fails to meet monograph standard Any Person
- Sell or supply non-compliant named medicinal products Any Person
Pharmacy records
- Keep records of prescription-only medicine sales and supplies Trader
Prohibitions concerning traceability of treatment with advanced therapy medicinal products
- Treat patient with advanced therapy product without traceability system Any Person
Offences relating to dealings with medicinal products
Unlimited fine- Breach rules on selling, prescribing, or supplying medicines Any Person
- Illegally sell or supply prescription medicines Any Person
Disqualification on conviction
Unlimited fine- Use pharmacy premises while disqualified Any Person
Browse 48 other sections in this Part — procedural / definitional / commencement
Interpretation
Exceptions to regulation 215
Requirements for prescriptions to be dispensed in an EEA state ...
Original pack dispensing: medicinal products containing a relevant substance
Requirements for prescriptions: general
Requirements for prescriptions: approved country health professional
Electronic prescriptions
Exemptions for doctors and dentists etc
Emergency sale etc by pharmacist: prescriber unable to provide prescription
Emergency sale etc by pharmacist: at patient's request
Emergency sale etc by pharmacist: pandemic diseases
Exemption for sale or supply in hospitals
Exemptions relating to prescriptions given by certain health professionals
Exemption for supply by national health service bodies and local authorities
Exemption for supply etc under a PGD to assist doctors or dentists
Exemption for supply etc under a PGD by independent hospitals etc
Exemption for supply etc under a PGD by dental practices and clinics: England and Wales
Exemption for supply etc under a PGD by person conducting a retail pharmacy business
Exemption for supply etc of products under a PGD to assist the police etc
Exemption for sale, supply or administration by certain persons
Exemption for supply or administration of certain medicines used for vaccination
Products consisting of or containing aloxiprin, aspirin or paracetamol
Products consisting of or containing pseudoephedrine salts or ephedrine base or salts
Appropriate suppliers of naloxone products
Administration of certain medicines in an emergency
Administration of smallpox vaccine
Radioactive medicinal products
Exemptions in respect of certain herbal remedies
Exemption for medicinal products at high dilution
Exemption for certain homoeopathic medicinal products
Exemption in cases involving another's default
Exemption in case of forged prescription
Exemption where requirements for prescriptions not met
Exemption for supply in the event or anticipation of pandemic disease
Exemption for certain collection and delivery arrangements
Exceptions to regulation 249
Compliance with standards specified in certain publications: supplementary
Offences relating to Commission Regulation 2016/161: management of the repository system
Electronic Prescriptions: approved country health professionals
Enforcement notices relating to Commission Regulation 2016/161: persons authorised to supply medicinal products to the public
Exception to Article 25 of Commission Regulation 2016/161: health care institutions
Hub and spoke arrangements: sharing of data between different businesses
Original pack dispensing
Original pack dispensing: medicinal products containing a relevant substance: Northern Ireland
Original pack dispensing: Northern Ireland
Protocols relating to coronavirus and influenza vaccinations and immunisations
Sale etc by a pharmacist in accordance with a serious shortage protocol
Sale or supply of items dispensed by a pharmacist who is absent or treated as absent
Part 12A — Sale of medicines to the public at a distance
Procedure for listing persons who may supply medicinal products at a distance
Other duties (1) — Crown / regulator
- Licensing authority must decide on distance selling list applications Statutory regulator
Provision of information to the licensing authority
2 years imprisonment- Report falsified medicines and changes to your register entry Any Person
Grant or refusal to list a person
Other duties (1) — Crown / regulator
- Licensing authority must process applications and publish listing details Statutory regulator
Conditions to be met by a person entered on the list
- Display required links and logo for online medicine sales Any Person
Procedure where the licensing authority proposes to suspend, vary or remove a person’s entry on the list
Other duties (1) — Crown / regulator
- Licensing authority must follow set procedures to change or remove a listing Statutory regulator
Variation of a person’s entry on the list on the application of that person
Other duties (1) — Crown / regulator
- Licensing authority must decide on entry variations within 30 days Statutory regulator
Offences: breach of regulations and false information
2 years imprisonment- Breach of medicines distance selling or false information rules Any Person
- Breach of medicines regulations or give false information Any Person
Browse 8 other sections in this Part — procedural / definitional / commencement
Interpretation
Removal of a person’s entry from the list
Suspension of a person’s entry on the list in cases of urgency
Penalties
Application of Part
Notification requirements for sellers of medicinal products at a distance
Person who may sell medicinal products by information society services
Power to suspend, vary or remove a person’s entry on the list
Part 13 — Packaging and leaflets
Packaging requirements: variation in accordance with regulation 68(11I)
Other duties (1) — Crown / regulator
- MHRA may require specific packaging statements for Great Britain medicines Statutory regulator
Packaging requirements: advanced therapy medicinal products
- Label and package advanced therapy medicinal products correctly Manufacturer
Packaging requirements: POC medicinal products
2 years imprisonment- Ensure correct labelling on POC medicinal product packaging Manufacturer
Packaging requirements: general
2 years imprisonment- Label and package medicinal products correctly Any Person
Packaging requirements: information for blind and partially sighted patients
2 years imprisonment- Provide medicine names in Braille and leaflets in accessible formats Manufacturer
Package leaflets
- Provide a clear and compliant package leaflet for medicinal products Applicant
Use of pictures and symbols etc
- Ensure packaging and leaflets do not contain promotional material Manufacturer
Labelling requirements for radionuclides
2 years imprisonment- Follow specific labelling requirements for radioactive medicines Manufacturer
Leaflets relating to radionuclides
Other duties (1) — Crown / regulator
- MHRA must ensure radionuclides include detailed instruction leaflets Statutory regulator
Homoeopathic medicines
- Ensure homoeopathic medicines are correctly labelled and packaged Manufacturer
Language requirements etc
2 years imprisonment- Use English for medicinal product information and packaging Manufacturer
Submission of mock-ups of packaging and leaflets to licensing authority
- Submit medicine packaging mock-ups and leaflets for approval Any Person
Offence relating to packaging and package leaflets in Northern Ireland: holder of authorisation etc
2 years imprisonment- Fail to provide compliant packaging or leaflets for medicines in NI Any Person
- Sell or supply medicines in NI with incorrect packaging or leaflets Any Person
Offence relating to packaging and package leaflets in Great Britain : holder of authorisation etc
- Sell medicinal product with non‑compliant packaging or leaflet Any Person
- Supply medicines with non-compliant packaging or leaflet Any Person
Offences relating to packaging and package leaflets in Northern Ireland: other persons
2 years imprisonment- Sell medicinal product with non‑compliant packaging or leaflet in NI Any Person
- Sell or supply medicines with incorrect packaging or leaflets in Northern Ireland Any Person
Offences relating to packaging and package leaflets in Great Britain : other persons
- Sell medicinal product with non‑compliant packaging or leaf‑let Any Person
- Supply medicine with faulty packaging or missing leaflet Any Person
Non-compliance with requirements of this Part
- Fail to comply with medicines regulator improvement notice Any Person
- Fail to comply with MHRA compliance notice Any Person
Child resistant containers for regulated medicinal products
- Use child-resistant and opaque packaging for regulated medicines Trader
Offences
2 years imprisonment- Sell medicinal product in improper container or prohibited aspirin/paracetamol Any Person
- Sell medicines in wrong packaging or banned children's painkillers Any Person
Browse 11 other sections in this Part — procedural / definitional / commencement
Packaging requirements: specific provisions
Additional requirements for traditional herbal medicinal products
Offences: penalties
Interpretation
Exemptions from regulation 273
Colouring of aspirin and paracetamol products for children
Guidance as to packaging and package leaflets
Packaging Requirements: medicinal products required to bear safety features
Regulation-making power as to certain forms of labelling
Transitional arrangements
Transitional Arrangements
Part 14 — Advertising
Products without a marketing authorisation etc
- Advertise medicinal product without marketing authorisation Any Person
- Publish unauthorised medicinal product advertisement Any Person
General principles
- Ensure all medicines advertising is accurate, objective, and approved Any Person
Duties of authorisation holders and registration holders
- Establish a scientific service and maintain advertising records Any Person
Products for the purpose of inducing abortions
Unlimited fine- Publish advertisement for abortion-inducing products Any Person
- Publish advertisement likely to promote abortion medication Any Person
Medicines with differing classification status in Great Britain and Northern Ireland
- Include regional availability statements in medicine advertisements Trader
Material relating to diagnosis
Unlimited fine- Publish misleading diagnosis-related medical ads Any Person
- Publish prohibited medicinal product advertisement Any Person
Material about status of medicinal product
Unlimited fine- Publish misleading advertisement for a medicinal product Any Person
- Publish misleading medicinal product advertisement Any Person
Advertisements directed at children
- Advertise medicinal products to children Any Person
- Publish medicinal product advertisement directed at children Any Person
Prohibition of supply to the public for promotional purposes
Unlimited fine- Supply medicines to the public for promotional purposes Any Person
Free samples for persons qualified to prescribe or supply medicinal products
- Meet strict conditions before supplying free medicine samples Distributor
Advertisements for registered homoeopathic medicinal products
2 years imprisonment- Restrict content of advertisements for registered homeopathic products Any Person
Advertisements for traditional herbal medicinal products
- Include specific wording in advertisements for traditional herbal medicines Any Person
Requirement to provide copy advertisement
- Provide copies of medicinal product advertisements to Ministers upon request Any Person
Decision about compatibility
Other duties (1) — Crown / regulator
- Ministers must issue a final decision on medicine advertisement compatibility Crown / Minister / Government department
Corrective statement
- Publish a corrective statement if your medicine advertisement is ruled illegal Any Person
Offences
Unlimited fine- Fail to comply with MHRA notice or corrective requirement Any Person
- Fail to comply with regulatory notice or corrective statement requirement Any Person
Complaints to Ministers: duty to consider
Other duties (1) — Crown / regulator
- Ministers must consider complaints about illegal medicine advertisements Crown / Minister / Government department
Grant of injunction: publication of decision and corrective statement
- Publish court decisions and corrective statements if ordered Any Person
Browse 24 other sections in this Part — procedural / definitional / commencement
Interpretation
Functions of the Ministers
Application of regulations 283 to 292
Prescription only medicines
Narcotic and psychotropic substances
Material about effects of medicinal product
Recommendations by scientists etc
Campaigns relating to the suspected or confirmed spread of pathogenic agents etc.
Form and content of advertisement
Exception for approved vaccination campaigns
General requirements
Abbreviated advertisements
Exception for advertisements intended as a reminder
Written material accompanying promotions
Medical sales representatives
Inducements and hospitality
Offences
Invitation to make representations about compatibility
Complaints to Ministers: power to refer
Application for injunction
Application for injunction: accuracy of factual claim
Complaints to OFCOM
Public interest etc
Civil proceedings
Part 15 — British Pharmacopoeia
Lists of names
Other duties (1) — Crown / regulator
- Government must publish official lists of approved medicine names Crown / Minister / Government department
Other documents
Other duties (1) — Crown / regulator
- BPC must prepare and Ministers may publish documents on medicines Statutory regulator
Browse 3 other sections in this Part — procedural / definitional / commencement
British Pharmacopoeia and compendia
Supplementary provisions
Specified publications
Part 16 — Enforcement
Enforcement in Northern Ireland
Other duties (1) — Crown / regulator
- Minister for Health must enforce medicines regulations in Northern Ireland Crown / Minister / Government department
Regulation 327: supplementary
Other duties (1) — Crown / regulator
- Regulators must provide ID and notify owners when seizing items Statutory regulator
Application of sampling procedure to substance or article seized under this Part
Other duties (1) — Crown / regulator
- Inspector must provide a sample of seized medicines upon request Statutory regulator
Findings and reports of inspections
Other duties (1) — Crown / regulator
- Regulators must report on inspection findings and allow business comments Statutory regulator
Supplementary provisions and offences
Unlimited fine- Obstruct an inspector, give false information, or unlawfully disclose information Any Person
- Obstruct inspector or refuse to comply/assist Any Person
Browse 9 other sections in this Part — procedural / definitional / commencement
Validity of decisions and proceedings
Enforcement in England, Wales and Scotland
Rights of entry
Application for warrant
Powers of inspection, sampling and seizure
Analysis of samples: other cases
Restrictions on disclosure of information
Protection for inspectors
Guidelines on inspections
Part 17 — Miscellaneous and general
Offences in relation to warranties and certificates
2 years imprisonment- Apply false warranty or certificate to a medicine Any Person
- Misuse of warranties or certificates for medicines Any Person
Offences by bodies corporate and partnerships
2 years imprisonment- Personal liability for directors and officers in medicines offences Director or Officer
Decisions under these Regulations
Other duties (1) — Crown / regulator
- Licensing authority must provide reasons and appeal info for decisions Statutory regulator
Time limits for provision of information etc
- Provide information or assistance within the regulator's specified deadline Any Person
Payment of expenses by Ministers
Other duties (1) — Crown / regulator
- Government must pay enforcement expenses to regulators Crown / Minister / Government department
Obligation on licensing authority to maintain list of medicinal products to which derogations have applied
Other duties (1) — Crown / regulator
- Licensing authority must maintain and update list of medicine exemptions Statutory regulator
Review
Other duties (1) — Crown / regulator
- Secretary of State must review medicines regulations every five years Crown / Minister / Government department
Browse 13 other sections in this Part — procedural / definitional / commencement
Contravention due to fault of another person
Warranty as defence
Prosecutions
Presumptions
Service of documents
Regulation making powers
Immunity from civil liability
Transitional provisions and savings
Amendments to existing law
Repeals and revocations
Modifications to deal with serious shortages
Transitional provision in relation to EU exit
Transitional provision relating to the Windsor Framework
Schedules
Applications for licences under Part 3
- Submit detailed information when applying for a manufacturer's licence Applicant
Standard provisions of licences under Part 3
2 years imprisonment- Comply with standard manufacturer's licence conditions Licence Holder
Material to accompany an application for a traditional herbal registration
- Submit required information for traditional herbal registration Applicant
Requirements for specific products subject to general sale
- Limit pack sizes for aspirin, paracetamol, and ibuprofen on general sale Trader
Labelling requirements for registrable homoeopathic medicinal products
2 years imprisonment- Follow specific labelling requirements for homeopathic medicines Manufacturer
Labelling of traditional herbal medicinal products
- Label traditional herbal medicinal products with required safety statements Any Person
The Ministers must provide each advisory body with such staff,...
Other duties (1) — Crown / regulator
- Ministers must provide advisory bodies with resources to operate Crown / Minister / Government department
Where the manufacturer's licence relates to the assembly of a...
- Inform customers about missing product labelling details Licence Holder
Where— (a) the manufacturer's licence relates to the assembly of...
- Notify MHRA of changes to manufacturer or importer details Licence Holder
The licence holder must keep readily available for examination by...
- Keep records of intermediate products used to make biological medicines Licence Holder
The licence holder must take all reasonable precautions and exercise...
- Ensure accuracy of information provided to the licensing authority Licence Holder
A licence holder may only manufacture or assemble EAMS medicinal...
- Only manufacture EAMS medicines for the Early Access to Medicines Scheme Licence Holder
The licence holder must maintain an MM master file for...
- Maintain an MM master file for each licensed MM medicinal product Licence Holder
The licence holder must ensure that the information contained in...
- Keep MM master file up to date and consistent with marketing authorisation Licence Holder
The licence holder must make the MM master file available...
- Make MM master file available to licensing authority on request Licence Holder
The licence holder must submit to the licensing authority, at...
- Submit annual updates to your MM master file Licence Holder
The licence holder must keep under review the arrangements for...
- Keep your manufacturing supervision arrangements under review Licence Holder
(1) The licence holder must record all suspected adverse reactions...
- Record and report suspected adverse reactions to MM medicinal product Licence Holder
The licence holder must maintain a POC master file for...
- Maintain a POC master file for each POC medicinal product Licence Holder
The licence holder must ensure that the information contained in...
- Keep POC master file information up to date and consistent with marketing authorisation Licence Holder
The licence holder must make the POC master file available...
- Make POC master file available to the licensing authority on request Licence Holder
The licence holder must submit to the licensing authority, at...
- Submit annual POC master file updates to the licensing authority Licence Holder
The licence holder must keep under review the arrangements for...
- Review and maintain adequate supervision and control at POC sites Licence Holder
(1) The licence holder must record all suspected adverse reactions...
- Record and report suspected adverse reactions for POC medicinal products Licence Holder
The licence holder must place the quality control system referred...
- Place quality control system under a notified qualified person Licence Holder
The licence holder must provide such information as may be...
- Provide import information to the licensing authority on request Licence Holder
The licence holder must— (a) keep readily available for inspection...
- Keep batch documentation available for inspection and allow copies Licence Holder
The licence holder must place the quality control system referred...
- Place quality control system under authority of notified person Licence Holder
Where the licence holder has been informed by the licensing...
- Withhold non-conforming batches from distribution when directed Licence Holder
The licence holder must ensure that any tests for determining...
- Test ingredients from finished medicinal product or at approved earlier stage Licence Holder
(1) Where and in so far as the licence relates...
- Give 28 days' notice before importing special medicinal products Licence Holder
The licence holder must take all reasonable precautions and exercise...
- Ensure information provided to licensing authority is not false or misleading Licence Holder
A licence holder— (a) in Great Britain may only supply...
- Supply special medicinal products between GB and NI only on valid orders Licence Holder
The licence holder in Great Britain must take all reasonable...
- Don't provide false or misleading information to the medicines regulator Licence Holder
The licence holder must ensure that the immediate packaging of...
- Label immediate packaging of exempt advanced therapy medicinal products correctly Licence Holder
The licence holder must ensure that the package leaflet of...
- Include all required particulars in the package leaflet Licence Holder
The licence holder must keep the data referred to in...
- Keep clinical trial data for the period set by the licensing authority (over 30 years) Licence Holder
The licence holder must not use any premises for the...
- Only use licensed or approved premises for medicines handling and storage Licence Holder
The licence holder must provide such information as may be...
- Provide information about medicines you handle, store or distribute Licence Holder
The licence holder must take all reasonable precautions and exercise...
- Ensure information provided to the licensing authority is not false or misleading Licence Holder
Where and in so far as the licence relates to...
- Only import special medicinal products from approved countries under strict conditions Licence Holder
No later than 28 days prior to each importation of...
- Notify MHRA at least 28 days before importing a special medicinal product Licence Holder
Where the licence holder sells or supplies special medicinal products...
- Record batch numbers and adverse reactions for special medicines Licence Holder
The licence holder must not, on any one occasion, import...
- Limit the quantity of special medicinal products imported per occasion Licence Holder
The licence holder must inform the licensing authority immediately of...
- Notify the MHRA immediately if an imported medicine becomes unsafe Licence Holder
The licence holder must provide such information as may be...
- Provide information about your manufacturing activities when requested by the licensing authority Licence Holder
The licence holder must not publish any advertisement, catalogue, or...
- Do not advertise special or EAMS medicinal products Licence Holder
The licence holder must cease importing or supplying a special...
- Cease importing or supplying special/EAMS products upon written notice from licensing authority Licence Holder
A licence holder— (a) in Great Britain may only supply...
- Only supply special medicinal products across GB-NI border with a compliant order Licence Holder
The licence holder shall keep the data referred to in...
- Retain data for over 30 years as specified by licensing authority Licence Holder
The licence holder must inform the licensing authority of any...
- Notify MHRA of changes to key personnel Licence Holder
The licence holder must— (a) keep readily available for inspection...
- Keep batch documentation available for inspection by licensing authority Licence Holder
The licence holder must keep readily available for examination by...
- Keep batch samples of finished medicinal products available for inspection Licence Holder
Where the licence holder has been informed by the licensing...
- Withhold non-conforming batch from distribution when directed Licence Holder
The licence holder must ensure that tests for determining conformity...
- Test medicinal product samples after manufacturing is complete Licence Holder
(1) The licensing authority must— (a) appoint a panel of...
Other duties (1) — Crown / regulator
- Licensing authority must appoint a review panel and provide hearing opportunity Statutory regulator
(1) The applicant must supply the reviewers with a written...
- Submit written summary of oral representations and supporting documents within 3 months Applicant
(1) After the hearing the reviewers must provide a report...
Other duties (1) — Crown / regulator
- Licensing authority must decide and notify applicant within 60 days of hearing report Statutory regulator
The licence holder must secure that the data referred to...
- Arrange data access with a manufacturer’s licence holder if your licence ends Licence Holder
The licence holder must, where an exempt advanced therapy medicinal...
- Ensure traceability system meets requirements for human cells and tissues Licence Holder
The licence holder must not import or export any exempt...
- Do not import or export exempt advanced therapy medicinal products Licence Holder
The licence holder must obtain supplies of exempt advanced therapy...
- Obtain exempt advanced therapy medicinal products only from licensed suppliers Licence Holder
The licence holder must distribute an exempt advanced therapy medicinal...
- Distribute exempt therapy products only to authorised recipients Licence Holder
The licence holder must establish and maintain a system ensuring...
- Set up a traceability system for advanced therapy medicinal products Licence Holder
The licence holder must inform the licensing authority of any...
- Report adverse reactions to exempt advanced therapy medicines Licence Holder
The licence holder must, subject to paragraph 44 of Schedule...
- Keep product data for 30 years after medicine expiry Licence Holder
The licence holder must secure that the data referred to...
- Ensure medicine data stays available if your licence ends Licence Holder
The licence holder must inform the licensing authority of any...
- Report adverse reactions to medicines to the MHRA within 15 days Licence Holder
The licence holder must not import or export any exempt...
- Do not import or export exempt advanced therapy medicinal products Licence Holder
The licence holder must ensure, if using human cells or...
- Ensure human cell/tissue donation, procurement and testing follows legal requirements Licence Holder
The licence holder must ensure that any human tissue or...
- Ensure imported human tissue/cells meet equivalent quality and safety standards Licence Holder
The licence holder must ensure that any blood or blood...
- Ensure imported blood meets UK quality and safety standards Licence Holder
Where the holder of a manufacturer's licence distributes by way...
- Follow EU good distribution practice for exempt advanced therapy products Manufacturer
The licence holder must, at the written request of the...
- Set up a risk management system when the licensing authority asks in writing Licence Holder
The licence holder must establish and maintain a system ensuring...
- Set up a traceability system for advanced therapy medicinal products Licence Holder
The licence holder must, subject to paragraph 27 of Schedule...
- Keep exempt advanced therapy product data for 30 years after expiry Licence Holder
Information to be provided for registration as an importer, manufacturer or distributor of active substances
- Provide required information when registering to handle active substances Manufacturer
Material to accompany an application for a parallel import licence
- Submit required documents for a parallel import licence application Applicant
The manufacturer must provide and maintain such staff, premises and...
- Provide and maintain adequate staff, premises and plant for medicine manufacture Manufacturer
The manufacturer must keep readily available for examination by a...
- Keep samples of batches and starting materials for inspection Manufacturer
(1) The manufacturer must implement a system for recording and...
- Set up a complaints and recall system for medicinal products Manufacturer
The manufacturer must inform the holder of the UK marketing...
- Notify marketing authorisation holder of material changes to facilities, equipment, operations, and arrangements Manufacturer
The manufacturer must provide and maintain such staff, premises, equipment...
- Provide and maintain staff, premises, equipment and facilities to prevent medicine deterioration Manufacturer
The manufacturer must provide and maintain a designated quality control...
- Set up an independent quality control department Manufacturer
The manufacturer must conduct all manufacture and assembly operations in...
- Manufacture medicines to the approved quality, strength and purity standards Manufacturer
The manufacturer must maintain an effective pharmaceutical quality assurance system...
- Maintain an effective pharmaceutical quality assurance system Manufacturer
Where animals are used in the production of any medicinal...
- House and manage animals in compliance with marketing authorisation Manufacturer
The manufacturer must make such adequate and suitable arrangements as...
- Test your medicines for strength, quality and purity as per your licence Manufacturer
The manufacturer must inform the holder of the UK marketing...
- Inform marketing authorisation holder of changes to premises, plant, or key personnel Manufacturer
(1) The manufacturer shall keep readily available for inspection by...
- Keep durable batch records of manufacture and tests Manufacturer
Measures to close the procedures specified in paragraphs 6 to 8
Other duties (1) — Crown / regulator
- Regulator must tell you if your variation is accepted or rejected Statutory regulator
Licensing authority recommendation on unclassified variations
- Request a recommendation on unclassified variations from the MHRA Manufacturer
(1) After receiving the appropriate committee's report under paragraph 7...
Other duties (1) — Crown / regulator
- Licensing authority must decide on marketing authorisation applications and notify the applicant Statutory regulator
(1) This paragraph applies if the appropriate committee has not...
Other duties (1) — Crown / regulator
- Licensing authority must notify applicants of non-safety related decisions Crown / Minister / Government department
(1) A person to whom a notification is given under...
- Respond to MHRA notification within 28 days (oral review or written representations) Any Person
Opportunity to make representations
Other duties (1) — Crown / regulator
- Licensing authority must notify applicant of proposed decision and allow representations Statutory regulator
Written representations
- Submit written representations within 28 days Applicant
Oral representations
- Provide written summary of oral representations within 28 days of request Applicant
Other decisions of the appropriate committee
Other duties (1) — Crown / regulator
- Committee must notify licensing authority if applicant fails to make representations Statutory regulator
Decision of licensing authority
Other duties (1) — Crown / regulator
- Licensing authority must decide on proposed decision and notify applicant Statutory regulator
(1) If the applicant requests the opportunity to make written...
- Submit written representations and documents within deadline after requesting the opportunity Applicant
(1) If the applicant requests the opportunity to make oral...
- Submit written summary and documents to committee for oral hearing request Applicant
(1) This paragraph applies if the applicant—
Other duties (1) — Crown / regulator
- Appropriate committee must notify licensing authority of applicant’s failure to make representations Statutory regulator
(1) After receiving the appropriate committee's report under paragraph 19...
Other duties (1) — Crown / regulator
- MHRA must confirm or alter decision after committee report and notify applicant Statutory regulator
(1) The licensing authority must notify the applicant of the...
- Request representations within 28 days of proposal notification Applicant
(1) If the applicant requests the opportunity to make written...
- Submit written representations within the deadline if you appeal a licence decision Applicant
(1) If the applicant requests the opportunity to make oral...
- Provide written summary and documents if you request an oral hearing Applicant
(1) This paragraph applies if the applicant—
Other duties (1) — Crown / regulator
- Appropriate committee must notify licensing authority if applicant fails to make representations Statutory regulator
(1) After receiving the appropriate committee's report under paragraph 26...
Other duties (1) — Crown / regulator
- Licensing authority must decide medicinal product applications and notify applicants Statutory regulator
(1) If the appropriate committee is consulted under paragraph 2(1)...
Other duties (1) — Crown / regulator
- Appropriate committee must notify you of provisional opinion in writing Statutory regulator
(1) If the applicant or holder requests the opportunity to...
- Submit written representations within 6 months (or shorter deadline set by committee) Applicant
(1) If the applicant or holder requests the opportunity to...
- Provide written summary of oral representations within 6 months of request Applicant
(1) This paragraph applies if the applicant or holder—
Other duties (1) — Crown / regulator
- Appropriate committee must notify the licensing authority when a hearing is missed Statutory regulator
Further provision as to the performance of pharmacovigilance activities
- Maintain and update a Pharmacovigilance System Master File (PSMF) Any Person
Management of human resources
- Manage human resources for pharmacovigilance activities Employer
Management of human resources
Other duties (1) — Crown / regulator
- Licensing authority must ensure competent personnel and training for pharmacovigilance Statutory regulator
Content of the individual case safety report
- Submit complete and accurate individual case safety reports to the MHRA Manufacturer
Format of electronic transmission of suspected adverse reactions
- Report suspected adverse reactions in specified electronic format Manufacturer
Summary of the risk management plan
- Provide a public summary of your risk management plan for each medicine Manufacturer
Updates of the risk management plan
- Submit updated risk management plan to the licensing authority Any Person
Content of periodic safety update reports
- Prepare and submit periodic safety update reports for your medicinal products Manufacturer
Obligations as to post-authorisation safety studies
- Properly manage post-authorisation safety studies (submit and store data) Manufacturer
Format of the study protocol
- Submit non-interventional safety study protocol in required format Manufacturer
Maintenance of the pharmacovigilance system master file
- Keep pharmacovigilance system master file up to date with version control Any Person
Form of the documents contained in the pharmacovigilance system master file
- Keep pharmacovigilance system master file documents complete, legible, and retrievable Any Person
Availability and location of the pharmacovigilance system master file
- Ensure permanent access to the pharmacovigilance system master file (PSMF) for qualified persons Manufacturer
Quality system
- Establish and use a quality system for pharmacovigilance activities Manufacturer
(1) This paragraph applies where the sampling officer has obtained...
Other duties (1) — Crown / regulator
- Sampling officer must notify UK manufacturer within 3 days Statutory regulator
A laboratory to which a sample is submitted under paragraph...
- Analyse or examine enforcement samples without delay Any Person
A laboratory that has analysed or examined a sample submitted...
- Send certificate of analysis results to the sampling officer Any Person
(1) If, in proceedings before a magistrates' court for an...
- Notify the other side if relying on a certificate or certifier as a witness Any Person
Powers of licensing authority in connection with provision of information
- Provide information to licensing authority upon request Any Person
Variations of converted EU marketing authorisations notified or applied for before IP completion day
- Handle pre-Brexit EU variations of converted marketing authorisations under UK rules Manufacturer
Variations of converted EU marketing authorisations submitted to EMA after IP completion day but before the data submission date
- Tell MHRA about EU variation notifications for converted marketing authorisations Any Person
Variations of converted EU marketing authorisations sought in advance of the data submission date
- Provide product information when requesting an early variation of a converted EU authorisation Manufacturer
Applications for renewals of converted EU marketing authorisations made before IP completion day
- Submit renewal application for converted EU marketing authorisation started before IP completion day Manufacturer
Applications for renewals of converted EU marketing authorisations made after IP completion day
- Submit baseline data with renewal application for converted EU marketing authorisation Manufacturer
Renewals of converted EU marketing authorisations sought in advance of the data submission date
- Provide specified product information with early renewal applications Manufacturer
Article 61(3) notifications made before IP completion day in relation to converted EU marketing authorisations
- Notify MHRA of EMA-notified labelling changes for converted EU marketing authorisations Any Person
Wholesale dealer's licence used to distribute a medicinal product imported from an EEA State before IP completion day
- Notify MHRA within 6 months to continue importing medicines from approved countries after Brexit Any Person
Article 61(3) notifications made in relation to converted EU marketing authorisations after IP completion day but before the data submission date
- Notify MHRA of EMA-labelling changes in baseline data and stop if opposed Manufacturer
Article 61(3) notifications sought in advance of the data submission date
- Notify MHRA of proposed changes to labelling or package leaflet before data submission date Any Person
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)
- Understand batch testing conditions for biological medicines after Brexit Manufacturer
Approved country for import list on IP completion day (regulation 18A)
Other duties (1) — Crown / regulator
- Licensing authority must publish and maintain an approved‑country list including all EEA states during the transitional period Statutory regulator
Applications made for a UK marketing authorisation before IP completion day to which Chapter 4 of Title III of the 2001 Directive applied
Other duties (1) — Crown / regulator
- Licensing authority must decide UK marketing authorisation applications within set timelines Statutory regulator
Transitional provision in respect of Plasma Master Files
- Notify MHRA of Plasma Master File updates and changes from EMA Any Person
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
Other duties (1) — Crown / regulator
- MHRA must finalise outstanding EU Article 31 referral procedures for UK marketing authorisations Crown / Minister / Government department
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)
Other duties (1) — Crown / regulator
- MHRA must assess pending variation applications under UK rules post-Brexit Statutory regulator
Qualified persons and approved country for batch testing list on IP completion day (Schedule 7)
Other duties (1) — Crown / regulator
- Licensing authority must publish and maintain batch testing country list Statutory regulator
Place of establishment for holders of certificates of registration established in EEA before IP completion day
- Appoint a UK contact person and notify MHRA Any Person
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
Other duties (1) — Crown / regulator
- MHRA must grant or determine pending homoeopathic product applications within specified timelines Statutory regulator
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
Other duties (1) — Crown / regulator
- MHRA must decide on incomplete EU referrals and act on certificates Statutory regulator
Place of establishment for holders of traditional herbal registrations established in EEA before IP completion day
- Notify MHRA of a UK-based contact person for your traditional herbal registration Any Person
List of countries with equivalent regulatory standards as to the manufacturing of active substances on IP completion day (regulation 45O(6) to (9))
Other duties (1) — Crown / regulator
- MHRA must publish list of equivalent countries for active substance import Statutory regulator
List of approved countries for traditional use of a herbal medicinal product on IP completion day
Other duties (1) — Crown / regulator
- Licensing authority must keep EEA states on approved countries list for traditional herbal medicines during transitional period Crown / Minister / Government department
Applications made for a traditional herbal registration before IP completion day to which Chapter 4 of Title III of the 2001 Directive applied
Other duties (1) — Crown / regulator
- Licensing authority must decide pending traditional herbal registration applications quickly Statutory regulator
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
Other duties (1) — Crown / regulator
- Licensing authority must finalise outstanding Article 31 referrals for traditional herbal registrations Statutory regulator
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
Other duties (1) — Crown / regulator
- MHRA must decide pending traditional herbal registration applications after Brexit day Statutory regulator
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
Other duties (1) — Crown / regulator
- Licensing authority must decide unfinished EU pharmacovigilance referrals for UK medicines Crown / Minister / Government department
Matters on-going at IP completion day in respect of periodic safety update reports
- Provide further information to MHRA if requested during ongoing PSUR assessment Any Person
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)
- Provide MHRA requested information on ongoing study protocols Any Person
Matters on-going at IP completion day in respect of the follow up of final study reports
- Complete follow-up steps for pending final study reports after IP completion day Any Person
Obligations of holders of converted EU marketing authorisations
- Submit baseline data for converted EU marketing authorisations Manufacturer
In section 123(1)(b) (offences in relation to warranties and certificates...
Unlimited fine- Give a false warranty or certificate of analysis Any Person
Browse 682 other Schedules — structural / supplementary
Further provisions for classification of medicinal products
Supplementary provision relating to advisory bodies and expert advisory groups
Material to accompany an application for a UK marketing authorisation
National homoeopathic products
The following medicinal products shall be available only on prescription—...
In this Part “cyanogenic substances” means preparations which—
The following medicinal products shall be available only from a...
The following medicinal products shall be available only from a...
A medicinal product shall be available only from a pharmacy...
(1) The person appointed to chair an advisory body is...
If an action is brought against a person arising out...
Paragraphs 8 to 10 shall have effect in relation to...
An advisory body or expert advisory group is not to...
(1) A member of an advisory body, other than its...
(1) The person appointed to chair an expert advisory group...
(1) This paragraph applies to a member of an expert...
The validity of any proceedings of an advisory body or...
(1) An advisory body may, subject to approval by the...
The Ministers may pay to the members of each advisory...
The Ministers must defray any expenses incurred with their approval...
Modifications of Commission Directive 2003/94/EC
(1) This paragraph applies to an application for a manufacturer's...
(1) This paragraph applies to an application for a manufacturer’s...
(1) This paragraph applies to an application for a manufacturer’s...
(1) This paragraph applies to an application for a manufacturer's...
(1) This paragraph applies to an application for a wholesale...
(1) If an application does not include information or other...
The provisions of this Part are standard provisions of a...
Where— (a) animals are used in the production of medicinal...
A licence holder— (a) in Great Britain may only supply...
The provisions of paragraphs 14D to 14K are incorporated as...
An MM master file may relate to one MM medicinal...
An MM master file must contain, as a minimum, the...
The provisions of paragraphs 14M to 14T are incorporated as...
A POC master file may relate to one POC medicinal...
A POC master file must contain, as a minimum, the...
The provisions of this Part are standard provisions of a...
The provisions of this Part are standard provisions of a...
The licence holder may use a contract laboratory pursuant to...
A licence holder may only import EAMS medicinal products if...
The provisions of paragraphs 25 to 27 are incorporated as...
The provisions of this Part are standard provisions of a...
The licence holder may use a contract laboratory pursuant to...
The provisions of paragraphs 33 to 42 are incorporated as...
A licence holder may only import EAMS medicinal products if...
The licence holder may not import the special medicinal product...
The licence holder may import the special medicinal product referred...
In this Part— “British approved name” means the name which...
The provisions of paragraph 44 are incorporated as additional standard...
(1) This Schedule applies if a person (“the applicant”) mentioned...
(1) Both the applicant and the licensing authority may make...
The requirements in paragraphs 2 to 12 apply to a...
The requirements in paragraphs 14 to 20 apply to a...
A person must satisfy the requirements in paragraphs 2 and...
(1) This paragraph applies to a person who—
If a person to whom paragraph 10 applies acquired the...
(1) In Great Britain, the qualified person is responsible for...
(1) In Northern Ireland, the qualified person is responsible for...
In the case of an MM medicinal product or a...
(1) This paragraph applies in Northern Ireland where—
(1) This paragraph applies where— (a) medicinal products are imported...
(1) The qualified person is responsible for ensuring, in relation...
The person must have a degree, diploma or other formal...
A qualification satisfies the requirements of this Part if it...
(1) A course should include at least the following core...
If the course referred to in paragraph 3 is followed...
If two university courses, or courses recognised as of university...
If the person's formal qualifications do not satisfy the requirements...
(1) The person must (subject to sub-paragraph (2)) have at...
(1) This paragraph applies to a person who has acted...
The name and address of the applicant.
The name, address and qualifications of the person to be...
The name, address and qualifications of the person to be...
For each active substance to be manufactured, imported, or distributed—...
Details of the operations to which the registration relates, including...
A statement of the facilities and equipment available at each...
A statement as to whether the particular active substances are...
A separate statement in respect of each of the premises...
A statement of the authority conferred on the person responsible...
A description of the arrangements for the identification and storage...
A description of the arrangements for the identification and storage...
The name and address of the person (if any) making...
A description of the arrangements at each of the premises...
A description of the arrangements for maintaining—
A description of the arrangements for keeping reference samples of—...
Where the application relates to active substances intended for use...
Details of— (a) any manufacturing, importation, storage or distribution operations,...
The address of each of the premises where any operations...
The address of any premises not mentioned by virtue of...
The address of each of the premises where active substances...
The address of each of the premises where any testing...
The name, address, qualifications and experience of the person whose...
The name, address, qualifications and experience of the person who...
The name, address, qualifications and experience of the person whose...
The name or corporate name and permanent address of the...
The results of the following in relation to the medicinal...
A detailed summary of those results prepared and signed by...
A summary of the applicant's pharmacovigilance system which shall include...
The risk management plan, together with a summary, that—
Where any clinical trials have been carried out outside the...
A summary of the product characteristics for the medicinal product...
(1) Subject to sub-paragraph (2), a mock-up, in accordance with...
A document showing that the manufacturer of the medicinal product...
Where— (a) in the case of a UKMA(NI) or a...
Where an authorisation for the medicinal product to be placed...
The name of the medicinal product. This may be—
Where , in the case of a medicinal product for...
Where an authorisation for the medicinal product to be placed...
In the case of a medicinal product for sale or...
For medicinal products included on the list referred to—
The name of the medicinal product followed by its strength...
The qualitative and quantitative composition, using the usual common name...
In the case of an advanced therapy medicinal product for...
The pharmaceutical form of the medicinal product.
Clinical particulars in relation to the medicinal product, covering—
The pharmacological properties of the medicinal product, covering—
Pharmaceutical particulars in relation to the medicinal product, covering—
Qualitative and quantitative particulars of the constituents of the medicinal...
The holder of the UK marketing authorisation.
The number of the UK marketing authorisation.
The date of the first UK marketing authorisation or, where...
The date of any revisions of the text of the...
For radiopharmaceuticals, full details of internal radiation dosimetry.
For radiopharmaceuticals, additional detailed instructions for extemporaneous preparation and quality...
In the case of an advanced therapy medicinal product for...
An evaluation of the potential environmental risks posed by the...
A description of the methods of manufacturing the medicinal product....
The therapeutic indications and contra-indications for the medicinal product and...
The posology and pharmaceutical form of the medicinal product, its...
The reasons for any precautionary and safety measures to be...
A description of the control methods employed by the manufacturer....
Except in the case of an active substance that contains...
The name or corporate name and permanent address of the...
The name of the medicinal product. This may be—
Details of the product to be imported if requested by...
Details of the UK reference product.
If requested by the licensing authority, an evaluation of the...
If requested by the licensing authority, a summary of the...
If requested by the licensing authority, the risk management plan,...
If requested by the licensing authority, a summary of the...
A mock-up, in accordance with Part 13 (packaging and leaflets)...
Modifications of Annex I to the 2001 Directive
Material to accompany an application for a UK marketing authorisation under the unfettered access route
A copy of the application submitted in connection with the...
A copy of all material submitted in support of the...
A copy of the EU marketing authorisation or UKMA(NI) which...
Meaning of terms used in the orphan criteria and in regulation 58D
Prevalence of a condition in the United Kingdom
Potential for return on investment
Existence of other methods of diagnosis, prevention or treatment
Increased safety or effectiveness and clinical superiority
(1) This paragraph applies for the purposes of the definition...
(1) This paragraph applies for the purposes of the definition...
(1) This paragraph applies for the purposes of the definition...
(1) This paragraph applies for the purposes of the definition...
(1) In this Schedule “national homoeopathic product” means a homoeopathic...
(1) An application for the grant of a UK marketing...
(1) The applicant must submit data as to the safety...
(1) The applicant does not need to submit data as...
(1) The applicant must submit data as to the efficacy...
Variations to a UK marketing authorisation
Interpretation
Extensions of marketing authorisations
Human influenza vaccines
Pandemic situation with respect to human influenza
Urgent safety restrictions
Amendments to the decision granting the marketing authorisation
Implementation of variations
Continuous monitoring
Classification of variations
Variations leading to the revision of product information
Grouping of variations
Notification procedure for minor variations of type IA
Notification procedure for minor variations of type IB
Prior approval procedure for major variations of type II
Elements to be submitted
(1) This Part of this Schedule applies to—
(1) A person to whom a notification is given under...
Application of this Part
Right to review after paragraph 13F notification
This Part applies— (a) to an application (a “Type II...
(1) In paragraph 14(b)(i) “complex variation application” means an application...
(1) In paragraph 14(b)(ii) “new excipient variation application” means an...
In relation to an application for a UKMA(NI) or THR(NI),...
(1) This paragraph applies if the licensing authority notifies the...
(1) The licensing authority must consult the appropriate committee if...
(1) This paragraph applies if the licensing authority notifies the...
(1) This Part applies if the licensing authority proposes to...
(1) Paragraph 2 does not apply to a proposal to...
(1) This paragraph applies if the licensing authority notifies the...
This Schedule does not apply to an application for the...
This Schedule does not apply to an application for the...
This Schedule ceases to apply if at any time the...
This Schedule does not apply to an application for a...
This Schedule does not apply to an application for a...
This Schedule does not apply if the application or proposal...
This Schedule does not apply if the application or proposal...
This Schedule does not apply if the application or proposal...
This Schedule does not apply if— (a) the licensing authority...
(1) Paragraph 2 does not apply to a proposal to...
(1) An applicant or holder notified under paragraph 5 may,...
The name or corporate name and permanent address of the...
Results of pre-clinical (toxicological and pharmacological) tests in relation to...
A detailed summary of those results prepared and signed by...
A summary of the product characteristics for the medicinal product...
A mock-up, in accordance with Part 13 (packaging and leaflets)...
A document showing that the manufacturer of the medicinal product...
Where the medicinal product consists of a combination of one...
Details of any authorisation or registration obtained by the applicant...
Details of any decision in a country other than the...
Bibliographical or expert evidence of the traditional use of the...
A bibliographic review of safety data.
The name of the medicinal product. This may be—
An expert report on safety.
For medicinal products included on the list referred to in...
The name of the medicinal product followed by its strength...
The qualitative and quantitative composition, using the usual common name...
The pharmaceutical form of the medicinal product.
The pharmacological properties of the medicinal product, covering—
Pharmaceutical particulars of the medicinal product, covering—
The holder of the traditional herbal registration.
The number of the traditional herbal registration.
The date of the first traditional herbal registration or, where...
Qualitative and quantitative particulars of the constituents of the medicinal...
The date of any revisions of the text of the...
An evaluation of the potential environmental risks posed by the...
A description of the methods of manufacturing the medicinal product....
The therapeutic indications and contra-indications for the medicinal product and...
The posology and pharmaceutical form of the medicinal product, its...
The reasons for any precautionary and safety measures to be...
A description of the control methods employed by the manufacturer....
Structure of the pharmacovigilance system master file
Compliance management
Record management and data retention
Audit
Compliance management
Record management and data retention
Audit
Use of internationally agreed terminology, formats and standards
Individual case safety reports
Content of the pharmacovigilance system master file
Content of the risk management plan
Format of the risk management plan
Format of periodic safety update reports
Scope and interpretation
Content of the Annex to the pharmacovigilance system master file
Format of the abstract of the final study report
Format of the final study report
Subcontracting
Performance indicators
Co-danthramer Capsules NPF Co-danthramer Capsules Strong NPF Co-danthramer Oral Suspension...
A clinical management plan must contain the following particulars—
A medicinal product that contains aloxiprin, aspirin or paracetamol (or,...
A medicinal product that contains ibuprofen and that is in...
The period during which the direction is to have effect....
The applicable dosage or maximum dosage.
The route of administration.
The frequency of administration.
Any minimum or maximum period of administration applicable to medicinal...
Whether there are any relevant warnings to note and, if...
Whether there is any follow up action to be taken...
Arrangements for referral for medical advice.
Details of the records to be kept of the supply,...
The description or class of medicinal product to which the...
The clinical situations which medicinal products of that description or...
Whether there are any restrictions on the quantity of medicinal...
The clinical criteria under which a person is to be...
Whether any class of person is excluded from treatment under...
Whether there are circumstances in which further advice should be...
The pharmaceutical form or forms in which medicinal products of...
The strength, or maximum strength, at which medicinal products of...
Ammonium bromide Calcium bromide Calcium bromidolactobionate Embutramide Fencamfamin hydrochloride Fluanisone...
Adrenaline 1:1000 up to 1mg for intramuscular use in anaphylaxis...
Doctors
Dentists
Persons lawfully conducting a retail pharmacy business within the meaning...
Authorities or persons carrying on the business of—
Holders of wholesale dealer's licences or persons to whom the...
Ministers of the Crown and Government departments.
Scottish Ministers.
Welsh Ministers.
A Northern Ireland Minister.
An NHS trust.
An NHS foundation trust.
The Common Services Agency.
A health authority or a special health authority.
A person other than an excepted person who carries on...
A person other than an excepted person who carries on...
In this Schedule “excepted person” means— (a) a doctor or...
Paragraph 2 applies, subject to paragraph 3, where the sale...
In such a case, the particulars referred to in regulation...
Where the sale or supply is in pursuance of a...
Where the sale or supply of a prescription only medicine...
Paragraph 6 applies where— (a) the sale or supply of...
In such a case, the particulars referred to in regulation...
The name of the medicinal product.
A warning that the product must be stored out of...
Any special warning applicable to the product.
The product's expiry date (month and year), in clear terms....
Any special storage precautions relating to the product.
Any special precautions relating to the disposal of an unused...
The name and address of the holder of the UK...
The number of the UK marketing authorisation, ... Article 126a...
The manufacturer's batch number.
In the case of a product that is not a...
In the case of a medicinal product, other than a...
The words “UK only”.
The name of the medicinal product.
The strength and pharmaceutical form of the product.
The strength and pharmaceutical form of the product.
Where appropriate, whether the product is intended for babies, children...
Where the product contains up to three active substances, the...
The name of the holder of the UK marketing authorisation,...
The product's expiry date (month and year), in clear terms....
The manufacturer's batch number.
The name of the medicinal product.
The strength and pharmaceutical form of the product.
Where appropriate, whether the product is intended for babies, children...
Where the product contains up to three active substances, the...
Where appropriate, whether the product is intended for babies, children...
The method of administration of the product and if necessary...
The product's expiry date (month and year), in clear terms....
The manufacturer's batch number.
The contents of the packaging by weight, by volume or...
The name of the advanced therapy medicinal product which is...
Where appropriate, whether the product is intended for babies, children...
The expiry date in clear terms including the year and...
A description of the active substance, expressed qualitatively and quantitatively....
Where the product contains tissues and cells of human or...
The pharmaceutical form and the contents by weight, volume or...
Where the product contains up to three active substances, the...
A list of excipients, including preservative systems.
The method of use, application, administration or implantation and, if...
A special warning that the product is to be stored...
Any special warning necessary for the particular product.
Any special storage precautions.
Specific precautions relating to the disposal of the unused product...
The name and address of the holder of the UK...
The UK marketing authorisation number.
The manufacturer's batch number.
The unique donation code assigned by a tissue establishment pursuant...
A statement of the active substances in the product, expressed...
Where the exempt advanced therapy medicinal product is for autologous...
The information specified in Part 2.
The unique donation code assigned by a tissue establishment pursuant...
Where the exempt advanced therapy medicinal product is for autologous...
The name of the medicinal product.
The strength and pharmaceutical form of the product.
Where appropriate, whether the product is intended for babies, children...
The expiry date, including the year and month and, if...
Where the product contains up to three active substances, the...
A statement of the active substances in the product, expressed...
The pharmaceutical form and the contents by weight, by volume...
The pharmaceutical form and the contents by weight, by volume...
A list of— (a) where the product is injectable or...
The method of administration of the product and if necessary...
Where appropriate, space for the prescribed dose to be indicated....
A warning that the product must be stored out of...
Any special warning applicable to the product.
Any special precautions relating to the disposal of an unused...
The name and address of the holder of the UK...
The number of the UK marketing authorisation for placing the...
The manufacturer’s batch number or other product identifier.
A list of— (a) where the product is injectable or...
The patient’s name and unique patient identifier.
The name of the medicinal product.
The strength and pharmaceutical form of the product.
Where appropriate, whether the product is intended for babies, children...
The expiry date, including the year and month and, if...
Where the product contains up to three active substances, the...
The method of administration of the product and if necessary...
The name of the holder of the UK marketing authorisation...
The manufacturer’s batch number or other product identifier.
The contents of the packaging by weight, by volume or...
The method of administration of the product and if necessary...
The patient’s name and unique patient identifier.
Where appropriate, space for the prescribed dose to be indicated....
Where the product is to be administered to a particular...
Paragraph 11 applies if a pharmacy medicine is—
Where this paragraph applies, the capital letter “P” within a...
Paragraph 13 applies if a prescription only medicine is—
Where this paragraph applies, the capital letters “POM” within a...
If the product contains paracetamol, except where the name of...
If the product contains paracetamol the words “Do not take...
If the product contains paracetamol, unless the product is wholly...
If the product contains paracetamol and is wholly or mainly...
If the product is required by this Part of this...
The name and address of the person who sells or...
The date on which the product is sold or supplied....
Unless paragraph 5, applies, such of the following particulars as...
This paragraph applies if the pharmacist, in the exercise of...
Where paragraph 5 applies, the pharmacist may include such particulars,...
Where a product is to be sold or supplied in...
Any special requirements for the storage and handling of the...
The expiry date of the product.
The manufacturer's batch number.
Where the product is to be administered to a particular...
Where paragraph 9 applies, the pharmacist may include such particulars,...
Where a product is to be sold or supplied in...
Where the product is not prescribed by an appropriate practitioner,...
The name and address of the person who sells or...
The date on which the product is sold or supplied....
Such of the following particulars as the person under whose...
Where a product is to be sold or supplied in...
Where the product is to be administered to a particular...
The name and address of the person who sells or...
The date on which the product is sold or supplied....
Where the product is prescribed by an appropriate practitioner, such...
This paragraph applies if a pharmacist, in the exercise of...
The name of the medicinal product.
A description of the adverse reactions which may occur in...
A reference to the expiry date printed on the packaging...
Where the product is authorised for sale or supply in...
For medicinal products included in the list referred to in...
A standardised text relating to adverse event reporting in accordance...
The date on which the package leaflet was last revised....
If a medicinal product contains paracetamol, unless the product is...
If a medicinal product contains paracetamol and is wholly or...
The name of the advanced therapy medicinal product.
Where appropriate, whether the product is intended for babies, children...
The strength and pharmaceutical form of the product.
The common name of the advanced therapy medicinal product.
The therapeutic group, or type of activity, of the product,...
Where the product contains cells or tissues, a description of...
Where the product contains medical devices or active implantable medical...
The product's therapeutic indications.
A list of information which is necessary before the medicinal...
The list mentioned in paragraph 25 must—
Instructions for proper use of the product including in particular—...
A description of the adverse reactions which may occur in...
A reference to the expiry date printed on the packaging...
Where appropriate, whether the product is intended for babies, children...
The date on which the package leaflet was last revised....
Where the product contains up to three active substances, the...
The pharmaco-therapeutic group, or type of activity, of the product,...
The product's therapeutic indications.
A list of— (a) contra-indications; (b) appropriate precautions for use;...
The list mentioned in paragraph 7 must—
Instructions for proper use of the product including in particular—...
The scientific name of the stock or stocks (which may...
The number of the certificate of registration.
The words “homoeopathic medicinal product without therapeutic indications”.
A warning advising the user to consult a doctor if...
The scientific name of the stock or stocks (which may...
The name and address of the holder of the certificate...
The product's expiry date (month and year), in clear terms....
The manufacturer's batch number.
The words “homoeopathic medicinal product without therapeutic indications”.
The scientific name of the stock or stocks (which may...
The name and address of the holder of the certificate...
The name and address of the holder of the certificate...
The method and, if necessary, route of administration.
The product's expiry date (month and year), in clear terms....
The contents of the presentation, specified by weight, volume or...
The manufacturer's batch number.
The words “homoeopathic medicinal product without therapeutic indications”.
The method and, if necessary, route of administration.
The product's expiry date (month and year), in clear terms....
The product's pharmaceutical form.
The contents of the presentation, specified by weight, volume or...
Special storage precautions, if any.
A special warning, if necessary in relation to the product....
The manufacturer's batch number.
A statement to the effect that the product is a...
A statement that the user should consult a doctor or...
Subject to the provisions of regulation 265(2), paragraph 4 applies...
Where this paragraph applies, the outer packaging and the immediate...
The number of the UK marketing authorisation , EU marketing...
The name and address of the holder of the temporary...
In relation to an advertisement in Great Britain (other than...
The classification of the medicinal product as—
The name of the medicinal product.
A list of the active ingredients of the medicinal product...
One or more of the indications for the medicinal product...
The entries or a succinct statement of the entries (if...
The cost excluding value added tax of—
(1) The particulars specified in paragraph 7 must be printed...
(1) This Schedule has effect where a person authorised by...
Unless the sampling officer decides not to submit the sample...
If a sample consists of substances or articles in unopened...
Regulation 343(1)(a) to (d) has effect in relation to supplying...
If after reasonable inquiry the sampling officer is unable to...
Where the enforcing authority that authorises the sampling officer is...
Where any other enforcing authority authorises the sampling officer, if...
(1) Arrangements of the kind mentioned in paragraphs 15(b) and...
The sampling officer must as soon as practicable—
A person to whom a part of the sample is...
(1) In proceedings for an offence under these Regulations, a...
In proceedings for an offence under these Regulations, a document...
(1) This paragraph applies where proceedings for an offence under...
The costs of analysis or examination under paragraph 24 are...
(1) In relation to England and Wales section 9 of...
(1) Where a sampling officer takes a sample in the...
If the sample was purchased by the sampling officer otherwise...
If the sampling officer obtained the sample from a vending...
If the sample is a sample of goods consigned from...
If, in a case not falling within any of paragraphs...
If, in a case not falling within any of paragraphs...
In any case not falling within any of paragraphs 3...
In every case falling within any of paragraphs 3 to...
(1) This paragraph applies where any provision of these Regulations...
(1) This paragraph applies to a marketing authorisation that—
(1) This paragraph applies to a product licence of right....
(1) Sub-paragraph (3) applies to a UK marketing authorisation granted...
No provision of these Regulations that applies only to advanced...
Regulation 9 (amendment of the Medicines for Human Use (Clinical...
(1) Section 60 of the Medicines Act 1968 (“the Act”)...
Pharmacovigilance system master file
The reference to “the EMA” in regulations 191(1) (obligation on...
Regulation 210(3)(b) (offences relating to pharmacovigilance obligations under Regulation (...
Post-authorisation safety studies
Regulation 210(3)(g) (offences relating to pharmacovigilance obligations under Regulation (EC)...
Reporting obligations
The references to “the Eudravigilance database” in regulation 188(1)(a) and...
The licensing authority must ensure that all reports and updated...
Regulations 186(1)(e) (reporting obligations on licensing authority in relation to...
Periodic safety update reports
Transitional provision in relation to EU Exit
In this Schedule— “ the COMP ” means the Committee...
Applications for renewals of conditional marketing authorisations made before IP completion day
Applications for renewals of conditional marketing authorisations made after IP completion day
Place of establishment for converted EU marketing authorisation holder established in EEA state before IP completion day
Temporary exemption as to packaging requirements for converted EU marketing authorisations
Referrals made under Article 20 of Regulation (EC) No 726/2004 that have not concluded or been implemented before IP completion day
Enforcement
Place of establishment for UK marketing authorisation holder or parallel import licence holder established in an EEA State before IP completion day
Status of certain UK marketing authorisations granted before IP completion day
Temporary exemption as to packaging requirements: change of place of establishment
Status of parallel import licences granted before IP completion day
Conversion of parallel distribution notices in to parallel import licences
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)
Existing data and marketing exclusivity and global marketing authorisations
Applications for EU marketing authorisations made before IP completion day
Place of establishment for UK marketing authorisation holder established in EEA state before IP completion day (pre-exit EU marketing authorisation applications)
Packaging in relation to UK marketing authorisations granted in response to application for EU marketing authorisation made before IP completion day
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
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)
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)
Transitional provision in relation to applications made to EMA before IP completion day under the Paediatric Regulation
Transitional provision in relation to global marketing authorisations under the 2001 Directive
List of countries for the purposes of the definition of “homoeopathic medicinal product” on IP completion day
Temporary exemption as to packaging requirements: change of place of establishment
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
Temporary exemption as to packaging requirements: change of place of establishment
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
Conversion of EU marketing authorisations in force before IP completion day
Approved country health professional list on IP completion day (regulation 214(6A))
Licensing authority power to require information
Classification of converted EU marketing authorisations
Obligations of licensing authority in connection with converted EU marketing authorisations
Transitional Provision in relation to the Windsor Framework
Existing marketing authorisations
Existing applications for marketing authorisation
Post-authorisation processes
The Medicines Act 1968 is amended as follows.
In section 72 (representative of pharmacist in case of death...
(1) The Co-ordination of Regulatory Enforcement (Regulatory Functions in Scotland...
In Schedule 1(3) to the Single Use Carrier Bags Charge...
For regulation 3(2)(b)(i) of the Control of Pesticides Regulations (Northern...
In rule 4 of the Prison and Young Offenders Centre...
In the Schedule to the Diseases of Animals (Importation of...
In Part 2 of Schedule 2 to the Pharmaceutical Services...
In Schedule 1, Chapter 4, Section 4.8, Part C of...
The Products of Animal Origin (Import and Export) Regulations (Northern...
In article 5(a) of the Importation of Animal Pathogens Order...
In Schedule 2 to the Biocidal Products Regulations (Northern Ireland)...
In section 82(4) (pharmacies: procedure relating to disqualification) for “Pharmaceutical...
(1) The Misuse of Drugs Regulations (Northern Ireland) 2002 are...
In regulation 5(2)(c) of the Control of Substances Hazardous to...
In paragraph 2 of Schedule 1 to the Waste Management...
(1) The Health and Personal Social Services (General Medical Services...
In regulation 13(6)(b) of the Nursing Homes Regulations (Northern Ireland)...
In regulation 13(6)(b) of the Nursing Homes Regulations (Northern Ireland)...
In regulation 20(4)(b) of the Children's Homes Regulations (Northern Ireland)...
In regulation 3(1) of the Healthy Start Scheme and Day...
In regulation 71(3)(a) of the Avian Influenza and Influenza of...
In regulation 13(6)(b) of the Day Care Setting Regulations (Northern...
In section 87 (requirements as to containers)—
In regulation 13(4)(b) of the Residential Family Centres Regulations (Northern...
In regulation 3(1)(a) of the Natural Mineral Water, Spring Water...
In article 5(2)(b) of the Specified Animal Pathogens Order (Northern...
In regulation 2(2) of the Controlled Drugs (Supervision of Management...
In regulation 4(b) of the Private Water Supplies Regulations (Northern...
In section 88(1) (distinctive colours, shapes and markings of medicinal...
In section 91 (offences under Part V, and supplementary provisions)—...
In section 104 (application of Act to certain articles and...
In section 105 (application of Act to certain other substances...
In section 107 (validity of decisions and proceedings relating thereto)—...
(1) Section 108 (enforcement in England and Wales) is amended...
In section 109 (enforcement in Scotland)— (a) in subsection (2)—...
For the text of section 1 (Ministers responsible for the...
In section 110 (enforcement in Northern Ireland)—
In section 111 (rights of entry)— (a) in subsection (1)...
In section 113(1) (application of sampling procedure to substance or...
In section 114(1) (supplementary provisions as to rights of entry...
In section 121(4) (contravention due to default of other person),...
In section 122(2) (warranty as defence), for the words “section...
In section 125 (prosecutions)— (a) in subsection (4)—
In section 126 (presumptions)— (a) in subsection (1), omit paragraph...
In section 128 (financial provisions)— (a) in subsection (1), for...
In section 10 (exemptions for pharmacists)— (a) in subsection (1)...
In section 129 (orders and regulations)— (a) in subsection (2),...
In section 130 (meaning of medicinal product and related expressions)—...
In section 131(5) (meaning of “wholesale dealing”, “retail sale” and...
In section 132 (general interpretation provisions)— (a) for subsection (1)...
In Schedule 3 (sampling)— (a) omit paragraphs 5 to 7;...
In Schedule 4 (provisions relating to Northern Ireland)—
(1) The Medicines Act 1971 shall have effect as follows....
In section 2(5)(b) (trade descriptions) of the Trade Descriptions Act...
In Part II (bodies of which all members are disqualified)...
In Part II (bodies of which all members are disqualified)...
In section 15 (provision for extending or modifying exemptions)—
Section 19(1) (interpretation of Part II) of the Consumer Protection...
In section 142(7) (powers to obtain information about potentially hazardous...
In Part II of Schedule 8 (zero-rating) to the Value...
In section 60(2A)(c) (regulation of health care and associated professions)...
In section 368R(1) (interpretation of Part 4A) of the Communications...
In section 7 (interpretation) of the Christmas Day and New...
The Health and Personal Social Services (Northern Ireland) Order 1972...
In article 2(2) of the Pharmacy (Northern Ireland) Order 1976...
In article 2(2) of the Pharmacy (Northern Ireland) Order 1976...
In article 38 of the Diseases of Animals (Northern Ireland)...
In section 58 (medicinal products on prescription only)—
In article 33(6) of the Waste and Contaminated Land (Northern...
In article 4(3) of the Shops (Sunday Trading &c.) (Northern...
The Medicines for Human Use (Clinical Trials) Regulations 2004 are...
In regulation 2(1) (interpretation)— (a) before the definition “the Act”...
In regulation 4(3) (responsibility for functions under the Directive) for...
In regulation 19(10) (authorisation procedure for clinical trials involving medicinal...
In regulation 46(2)(c) (labelling) for words from “Schedule 5” to...
In regulation 47 (application of enforcement provisions of the Act)—...
In regulation 48(5) (infringement notices) for “sections 108 to 110...
In regulation 49(5) (offences) for “the Act” substitute “ the...
In section 58A(1) (requirement to specify certain products as prescription-only...
In regulation 53(3) (construction of references to specified publications) for...
In paragraph 4(2) of Schedule 5 (procedural provisions relating to...
In Schedule 7 (standard provisions for manufacturing authorisations)—
In paragraph 5(2) of Schedule 8 (procedural provisions relating to...
For Schedule 9 substitute the following Schedule— SCHEDULE 9 MODIFICATIONS OF...
In regulation 8(1) of the Medicines (Administration of Radioactive Substances)...
In the Schedule to the Importation of Animal Products and...
In rule 2 of The Medicines Act (Hearings by Persons...
In rule 2 of The Medicines Act (Hearings by Persons...
(1) The Medicines (Fixing of Fees Relating to Medicinal Products...
In section 62 (prohibition of sale or supply, or importation,...
In regulation 1(2) of the Medical Devices (Consultation Requirements) (Fees)...
(1) The Prescription Only Medicines (Human Use) Order 1997 is...
In rule 7B(b) of the Schedule to the General Optical...
The National Health Service (Charges for Drugs and Appliances) Regulations...
In Schedule 2 to the Biocidal Products Regulations 2001 —...
In article 4(4) of the Medicines (Aristolochia and Mu Tong...
In regulation 2(1) of the Misuse of Drugs Regulations 2001...
In paragraph (d) of article 3 of the Medicines for...
In article 1(3) of the Medicines and Healthcare Products Regulatory...
In the column “specified UK laws” of the Schedule to...
In section 64(5) (protection for purchasers of medicinal products) for...
In the Schedule to the Enterprise Act 2002 (Part 8...
In article 6 of the Health Professions (Parts of and...
(1) The Unlicensed Medicinal Products for Human Use (Transmissible Spongiform...
(1) The National Health Service (General Medical Services Contracts) (Scotland)...
(1) The National Health Service (Primary Medical Services Section 17C...
(1) The National Health Service (General Medical Services Contracts) Regulations...
(1) The National Health Service (General Medical Services Contracts) (Wales)...
(1) The National Health Service (Personal Medical Services Agreements) Regulations...
In Schedule 2 to the National Health Service (General Medical...
(1) The Contracting Out (Functions relating to Broadcast Advertising) and...
(1) Section 67 (offences under Part III) is amended as...
In the Table in rule 10 of the Schedule to...
(1) The National Health Service (Free Prescriptions and Charges for...
In regulation 2(3) of the Human Tissue (Quality and Safety...
(1) The Schedule to the Legislative and Regulatory Reform (Regulatory...
In paragraph (d) of article 3 of the Medicines for...
In article 5(2) of the Specified Animal Pathogens Order 2008...
In article 5(2) of the Specified Animal Pathogens (Wales) Order...
In regulation 1(2) of the Health Service Branded Medicines (Control...
In article 5(2) of the Specified Animal Pathogens (Scotland) Order...
(1) The National Health Service (Pharmaceutical Services) (Scotland) Regulations 2009...
Pharmacists. Registered chiropodists and podiatrists. Registered dental hygienist. Registered dental...
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Official guidance
Authoritative sources published by regulators or government explaining this legislation.
- Unfettered access procedure for marketing authorisations approved in Northern Ireland (opens in a new tab) from MHRA Detailed Guidance
- Pharmacovigilance requirements: qualified person for PV and PSMF (opens in a new tab) from MHRA Detailed Guidance
- Banned or restricted herbal ingredients for medicinal use (opens in a new tab) from MHRA Detailed Guidance
- Clinical trials for medicines: Clinical Trials Regulations transitional arrangements (opens in a new tab) from MHRA Detailed Guidance
- Acting as a Responsible Person (import) (opens in a new tab) from MHRA Detailed Guidance
- Guidance for licensing electronic cigarettes and other inhaled nicotine-containing products as medicines (opens in a new tab) from MHRA Detailed Guidance
- Clinical trials for medicines: non-investigational medicinal products (opens in a new tab) from MHRA Detailed Guidance
- National assessment procedure for medicines (opens in a new tab) from MHRA Detailed Guidance
- Clinical trials for medicines: collection, verification and reporting of safety events (opens in a new tab) from MHRA Detailed Guidance
- Comparator products in bioequivalence/therapeutic equivalence studies (opens in a new tab) from MHRA Detailed Guidance
- ... and 39 more
Enforcement and responsible bodies
The regulators that administer or enforce this legislation.
MHRA
PrimaryMedicines and Healthcare products Regulatory Agency
Regulates medicines, medical devices, and blood components. Ensures safety, quality, and efficacy. Issues marketing authorisations.
General Optical Council
Statutory regulator for optometrists, dispensing opticians, student opticians, and optical businesses in the UK. Registers individuals and businesses, sets standards, and investigates …
General Pharmaceutical Council
Statutory regulator for pharmacists, pharmacy technicians, and pharmacy premises in Great Britain. Sets standards for pharmacy education, ethics, and practice. Inspects registered …
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Regulators
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