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The Human Medicines Regulations 2012

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The Human Medicines Regulations 2012 is up to date with all changes known to be in force on or before 25 December 2024. There are changes that may be brought into force at a future date. Help about Changes to Legislation

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  1. Introductory Text

  2. PART 1 General

    1. 1.Citation and commencement

    2. 2.Medicinal products

    3. 2A.Definition of advanced therapy medicinal product etc.

    4. 3.Scope of these Regulations: special provisions

    5. 3A.Preparation and assembly of medicinal products used for vaccination or immunisation against coronavirus or in the reformulation of such products

    6. 4.Special provisions for pharmacies etc

    7. 5.Classification of medicinal products

    8. 6.The licensing authority and the Ministers

    9. 7.Advertisements relating to medicinal products

    10. 8.General interpretation

  3. PART 2 Administration

    1. 9.Commission on Human Medicines

    2. 10.Functions of the Commission

    3. 11.British Pharmacopoeia Commission

    4. 12.Reporting to Ministers

    5. 13.Co-option of additional members of advisory bodies

    6. 14.Appointment of expert advisory groups

    7. 15.Delegation of functions to expert advisory groups

    8. 16.Further provision about advisory bodies and expert advisory groups etc

  4. PART 3 Manufacture and distribution of medicinal products and active substances

    1. CHAPTER 1 Interpretation

      1. A17.Interpretation

    2. Chapter 1A Good manufacturing practice and good distribution practice

      1. B17.Regulations on good manufacturing practice

      2. C17.Guidelines on good manufacturing practice and good distribution practice

    3. CHAPTER 2 Manufacturing and wholesale dealing

      1. Grant etc of licences

        1. 17.Manufacturing of medicinal products

        2. 18.Wholesale dealing in medicinal products

        3. 18A.Approved country for import

        4. 19.Exemptions from requirement for wholesale dealer's licence

        5. 20.Mixing of medicines

        6. 21.Application for manufacturer's or wholesale dealer's licence

        7. 22.Factors relevant to determination of application for manufacturer's or wholesale dealer's licence

        8. 23.Grant or refusal of licence

        9. 24.Standard provisions of licences

        10. 25.Duration of licence

        11. 26.General power to suspend, revoke or vary licences

        12. 27.Procedure where licensing authority proposes to suspend, revoke or vary licence

        13. 28.Suspension of licence in cases of urgency

        14. 29.Variation of licence on the application of the holder

        15. 30.Provision of information

      2. Miscellaneous and offences

        1. 31.Certification of manufacturer's licence

        2. 32.Sale and supply of starting materials

        3. 33.Offence concerning data for advanced therapy medicinal products

        4. 34.Offences: breach of regulations and false information and defence concerning starting materials

        5. 35.Penalties

      3. Conditions for holding a manufacturer's licence

        1. 36.Conditions for manufacturer's licence

        2. 37.Manufacturing and assembly

        3. 38.Imports from states other than EEA States / countries other than approved countries for import

        4. 39.Further requirements for manufacturer's licence

        5. 40.Obligation to provide information relating to control methods

        6. 41.Requirements as to qualified persons

      4. Conditions for holding a wholesale dealer's licence

        1. 42.Conditions for wholesale dealer's licence

        2. 43.Obligations of licence holder

        3. 43ZA.Obligations of licence holder in Great Britain supplying listed NIMAR products to Northern Ireland

        4. 43A.Requirement for wholesale dealers to decommission the unique identifier

        5. 44.Requirement for wholesale dealers to deal only with specified persons

        6. 45.Requirement as to responsible persons

        7. 45AA.Requirement as to responsible persons where licence holder imports from an approved country for import

        8. 45AB.Register for responsible persons (import)

    4. CHAPTER 3 Brokering

      1. 45A.Brokering in medicinal products

      2. 45B.Application for brokering registration

      3. 45C.Procedure for determining an application for broker’s registration

      4. 45D.Grant or refusal of broker’s registration

      5. 45E.Criteria of broker’s registration

      6. 45F.Provision of information

      7. 45G.Power to suspend or vary a broker’s registration or remove a broker from the register

      8. 45H.Procedure where licensing authority proposes to suspend or vary a broker’s registration or remove a broker from the register

      9. 45I.Suspension of a broker registration in cases of urgency

      10. 45J.Variation of a broker’s registration on the application of the broker

      11. 45K.Offences: breach of regulations and false information

      12. 45L.Penalties

    5. CHAPTER 4 Importation, manufacture and distribution of active substances

      1. 45M.Criteria for importation, manufacture or distribution of active substances

      2. 45N.Registration in relation to active substances

      3. 45O.Requirements for registration as an importer, manufacturer or distributor of an active substance

      4. 45P.Provision of information

      5. 45Q.Power to suspend or vary or remove an active substance registration

      6. 45R.Procedure where licensing authority proposes to suspend or vary an active substance registration or remove a person from the active substance register

      7. 45S.Suspension of an active substance registration in cases of urgency

      8. 45T.Variation of an active substance registration on an application from the registered person

      9. 45U.Offences: breach of regulations and false information

      10. 45V.Penalties

  5. PART 4 Requirement for authorisation

    1. 46.Requirement for authorisation

    2. 47.Breach of requirement

  6. PART 5 Marketing authorisations

    1. 48.Application of this Part

    2. Application for UK marketing authorisation

      1. 49.Application for grant of UK marketing authorisation or parallel import licence

      2. 50.Accompanying material

      3. 50A.Requirement for certain applications to include results of paediatric investigation plan

      4. 50B.Agreement and modification of paediatric investigation plan

      5. 50C.Deferral of initiation or completion of measures in paediatric investigation plan

      6. 50D.Waiver of production of information in a paediatric investigation plan

      7. 50E.Application for paediatric use marketing authorisation

      8. 50F.Other applications including paediatric indications

      9. 50G.Applications relating to orphan medicinal products

      10. 50H.Applications relating to advanced therapy medicinal products

      11. 50I.Applications relating to conditional marketing authorisations for sale or supply in Great Britain only

      12. 50J.Applications in relation to medicinal products containing or consisting of genetically modified organisms

      13. 51.Application for UKMA(NI) relating to generic medicinal products

      14. 51A.Application for UKMA(GB) relating to generic medicinal products

      15. 51B.Application for UKMA(UK) relating to generic medicinal products

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

      17. 52A.Application for UKMA(GB) relating to certain medicinal products that do not qualify as generic etc

      18. 52B.Application for UKMA(UK) relating to certain medicinal products that do not qualify as generic etc

      19. 53.Application for UKMA(NI) relating to similar biological medicinal products

      20. 53A.Application for UKMA(GB) relating to similar biological medicinal products

      21. 53B.Application for UKMA(UK) relating to similar biological medicinal products

      22. 54.Applications relating to products in well-established medicinal use

      23. 55.Applications relating to new combinations of active substances

      24. 56.Applications containing information supplied in relation to another product with consent

      25. 57.Obligation to update information supplied in connection with application

      26. 57A.Obligation to update information supplied in connection with parallel import licence application

    3. Consideration of application

      1. 58.Consideration of application

      2. 58A.Paediatric rewards

      3. 58B.Publication of information relating to paediatric marketing authorisations

      4. 58C.Consideration of applications relating to orphan medicinal products

      5. 58D.Orphan rewards

      6. 58E.Consideration of applications relating to combined advanced therapy medicinal products

      7. 58F.Consideration of applications relating to conditional marketing authorisations

      8. 58G.Consideration of applications in relation to medicinal products containing or consisting of genetically modified organisms

      9. 59.Conditions of UK marketing authorisation or parallel import licence: general

      10. 60.Conditions of UK marketing authorisation or parallel import licence: exceptional circumstances

      11. 60A.Condition as to the submitting of samples and other information to the appropriate authority

      12. 60B.Submitting of samples and other information: EU marketing authorisations

      13. 61.Conditions of UK marketing authorisation: new obligations post-authorisation

      14. 62.Classification of UK marketing authorisation or parallel import licence

      15. 63.Frequency of periodic safety update reports

      16. 64.Duties of licensing authority in connection with determination

      17. 64A.Obligation of licensing authority in case of change of classification

    4. Validity of UK marketing authorisation

      1. 65.Validity of UK marketing authorisation

      2. 65A.Validity of parallel import licence

      3. 65B.Validity of conditional marketing authorisation

      4. 65C.Variation of a UKMA(GB)

      5. 66.Application for renewal of authorisation

      6. 66A.Application for renewal of a parallel import licence

      7. 66B.Renewal of conditional marketing authorisation

      8. 67.Failure to place on the market etc

    5. Revocation, variation and suspension of marketing authorisation

      1. 68.Revocation, variation and suspension of UK marketing authorisation or parallel import licence

      2. 69.Suspension of use etc of relevant medicinal product

      3. 70.Authorisations granted under Chapter 4 of Title III of the 2001 Directive

      4. 71.Withdrawal of medicinal product from the market

      5. 72.Sale etc of suspended medicinal product

    6. Obligations of holder of marketing authorisation

      1. 73.Obligation to notify placing on the market etc

      2. 74.Obligation to take account of scientific and technical progress

      3. 75.Obligation to provide information relating to safety etc

      4. 76.Obligation in relation to product information

      5. 77.Record-keeping obligations

      6. 78.Obligation to ensure appropriate and continued supplies

      7. 78A.Post authorisation requirements in relation to UK marketing authorisations to which paediatric specific provisions apply

      8. 78B.Post authorisation requirements in relation to UKMA(GB) for advanced therapy medicinal products

    7. Offences relating to specific requirements

      1. 79.Failure to provide information on marketing authorisations to EMA

      2. 80.Urgent safety restrictions

      3. 80A.Urgent safety restrictions: parallel import licences

    8. Offences relating to EU marketing authorisations

      1. A81.Application of regulations 81 to 94

      2. 81.Obligation to update information supplied in connection with EU application

      3. 82.EU marketing authorisations: failure to notify placing on market etc

      4. 83.EU marketing authorisations: failure to take account of technical and scientific progress

      5. 84.EU marketing authorisations: failure to provide information as to safety etc

      6. 85.EU marketing authorisations: failure to update product information

      7. 86.EU marketing authorisations: breach of pharmacovigilance condition etc

    9. Offences relating to advanced therapy medicinal products

      1. 87.Offences in connection with risk management systems and traceability systems

      2. 88.Offence concerning data for advanced therapy medicinal products

    10. Offences relating to the Paediatric Regulation

      1. 89.Offences in connection with withdrawal of product from the market

      2. 90.Failure to place on the market taking account of paediatric indication

      3. 91.Failure to notify results of third country clinical trials

      4. 92.Failure of sponsor of UK paediatric clinical trial to notify results of trial

      5. 93.Failure to notify results of paediatric study

      6. 94.Failure to submit report to EMA

    11. Offences relating to the safety features appearing on the packaging of medicinal products

      1. 94A.Offences relating to Commission Regulation 2016/161

    12. General provisions relating to offences

      1. 95.Offences in connection with application

      2. 95A.Offences in connection with parallel import licence application

      3. 96.Provision of false or misleading information

      4. 97.Breach of pharmacovigilance condition

      5. 98.General offence of breach of provision of this Part

      6. 99.Penalties

      7. 100.Persons liable

      8. 101.Defences

  7. PART 6 Certification of homoeopathic medicinal products

    1. Application of Part

      1. 102.Application of Part

    2. Application for certificate of registration and consideration of application

      1. 103.Application for certificate of registration

      2. 104.Consideration of application

      3. 105.Conditions of certificate of registration

      4. 106.Classification of certificate of registration

      5. 107.Validity of certificate of registration

      6. 108.Application for renewal of certificate

      7. 109.Failure to place on the market etc

    3. Revocation, variation and suspension of certificate of registration

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

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

      3. 112.Withdrawal of homoeopathic medicinal product from the market

    4. Obligations of holder of certificate of registration

      1. 113.Obligation to notify placing on the market etc

      2. 114.Obligation to take account of scientific and technical progress

      3. 115.Obligation to provide information relating to safety etc

      4. 116.Obligation in relation to product information

      5. 117.Record-keeping obligation

      6. 118.Obligation to ensure appropriate and continued supplies

    5. Provisions relating to offences

      1. 119.Offences in connection with applications

      2. 120.Provision of false or misleading information

      3. 121.General offence of breach of provision of this Part

      4. 122.Penalties

      5. 123.Persons liable

      6. 124.Defences

  8. PART 7 Traditional herbal registrations

    1. Interpretation and application of Part

      1. 124A.Interpretation of this Part

      2. 125.Traditional herbal medicinal products

      3. 125A.List of approved countries for traditional use of a herbal medicinal product

      4. 126.Addition of vitamins or minerals

    2. List of herbal substances, preparations and combinations for use in traditional herbal medicinal products

      1. 126A.Licensing authority list as to herbal substances, preparations and combinations for use in traditional herbal medicinal products

    3. Application for traditional herbal registration

      1. 127.Application for grant of traditional herbal registration

      2. 128.Accompanying material

      3. 129.Obligation to update information supplied in connection with application

    4. Consideration of application

      1. 130.Consideration of application

      2. 130A.Procedure where less than 15 years use of traditional herbal medicinal product

      3. 131.Classification of traditional herbal registration

    5. Validity of traditional herbal registration

      1. 132.Validity of traditional herbal registration

      2. 133.Application for renewal of registration

      3. 134.Failure to place on the market etc

    6. Revocation, variation and suspension of traditional herbal registration

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

      2. 136.Revocation by licensing authority: further provisions

      3. 137.Procedures for revocation, variation or suspension

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

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

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

      7. 141.Sale etc of suspended traditional herbal medicinal product

    7. Obligations of holder of traditional herbal registration

      1. 142.Obligation to notify placing on the market etc

      2. 143.Obligation to take account of scientific and technical progress

      3. 143A.Establishment of herbal monographs

      4. 144.Obligation following new herbal monograph

      5. 145.Obligation to provide information relating to safety etc

      6. 146.Obligation in relation to product information

      7. 147.Record-keeping obligations

      8. 148.Obligation to ensure appropriate and continued supplies

      9. 148A.Urgent safety restrictions

    8. Offences relating to traditional herbal registrations

      1. 149.Urgent safety restrictions

      2. 150.Offences in connection with applications

      3. 151.Provision of false or misleading information

      4. 152.General offence of breach of provision of this Part

      5. 153.Penalties

      6. 154.Persons liable

      7. 155.Defences

  9. PART 8 Article 126a authorisations

    1. 156.Article 126a authorisations

    2. 157.Requests from EU member States

    3. 158.Application of these Regulations

  10. PART 9 Borderline products

    1. 159.Provisional determination

    2. 160.Challenge to provisional determination

    3. 161.Written representations procedure

    4. 162.Oral representations procedure

    5. 163.Final determination without representations

    6. 164.Effect of final determination

    7. 165.Determination in other cases

    8. 166.Offences relating to borderline products

  11. PART 10 Exceptions to requirement for marketing authorisation etc

    1. Exceptions

      1. 167.Supply to fulfil special patient needs

      2. 167A.NIMAR supply to Northern Ireland

      3. 167B.List of NIMAR products

      4. 167C.Early Access to Medicines Scheme: establishment and licensing authority functions

      5. 167D.EAMS scientific opinions ceasing to have effect

      6. 167E.EAMS medicinal products: manufacture, assembly, importation, distribution and supply

      7. 167F.Advertising of EAMS medicinal products

      8. 167G.EAMS medicinal products: pharmacovigilance

      9. 167H.Early Access to Medicines Scheme: data collection

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

      11. 169.Mixing of general sale medicinal products

      12. 170.Record-keeping requirements

      13. 171.Exempt advanced therapy medicinal products

      14. 172.Parallel import licences

      15. 173.Exemption for certain radiopharmaceuticals

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

      17. 174A.Conditions of temporary authorisations under regulation 174

    2. Offences

      1. 175.Offences relating to exceptions

      2. 176.Penalties and supplementary provision about offences

  12. PART 11 Pharmacovigilance

    1. 177.Application of this Part and interpretation

    2. Obligations on licensing authority in relation to pharmacovigilance

      1. 178.General obligations of the licensing authority

      2. 179.Obligation on licensing authority to operate pharmacovigilance system

      3. 180.Obligation on licensing authority to audit pharmacovigilance system

      4. 181.Delegation of obligations under this Part

    3. Obligations on holders in relation to pharmacovigilance system

      1. 182.Obligation on holder to operate pharmacovigilance system

      2. 183.Exception to obligation to operate risk management system

      3. 184.Obligation on holder to audit pharmacovigilance system

    4. Recording, reporting and assessment of pharmacovigilance data

      1. 185.Recording obligations on the licensing authority

      2. 186.Reporting obligations on the licensing authority

      3. 186A.The licensing authority must collaborate with the World Health Organisation...

      4. 187.Recording obligations on holders

      5. 188.Reporting obligations on holders

    5. Signal detection

      1. 189.Signal detection: licensing authority obligations

      2. 190.Signal detection: holder obligation

    6. Periodic Safety Update Reports

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

      2. 191A.Obligation on holder of a parallel import licence to submit periodic safety update reports

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

      4. 193.Harmonisation of PSUR frequency or date of submission

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

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

    7. Urgent action and major safety review

      1. 196.Urgent action

      2. 196A.Major safety review by the licensing authority

      3. 197.EU urgent action procedure

    8. Post-authorisation safety studies

      1. 198.Post-authorisation safety studies: general provisions

      2. 199.Submission of draft study protocols for required studies

      3. 200.Amendment to study protocols for required studies

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

      5. 202.Follow-up of final study reports

    9. Medicinal products subject to additional monitoring

      1. 202A.Licensing authority power in relation to medicinal products subject to additional monitoring

    10. Transparency and communications

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

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

      3. 205.Obligations on holders in relation to public announcements

    11. Further obligations in respect of pharmacovigilance activities

      1. 205A.Further obligations in respect of pharmacovigilance activities

    12. Guidance in respect of pharmacovigilance

      1. 205B.Guidance in respect of good pharmacovigilance practice and post authorisation efficacy studies

    13. Enforcement

      1. 206.Infringement notices

      2. 207.Offences

      3. 208.False and misleading information

      4. 209.Penalties

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

      6. 210A.Offences in relation to pharmacovigilance obligations under the Implementing Regulation and Schedule 12A

      7. 211.Persons liable

    14. Transitional arrangements

      1. 212.Transitional arrangements

  13. PART 12 Dealings with medicinal products

    1. CHAPTER 1 Interpretation

      1. 213.Interpretation

    2. CHAPTER 2 Sale and supply of medicines

      1. Prescription only medicines

        1. 214.Sale or supply of prescription only medicines

        2. 215.Prescribing and administration by supplementary prescribers

        3. 216.Exceptions to regulation 215

        4. 217.Requirements for prescriptions: general

        5. 217A.Requirements for prescriptions to be dispensed in an EEA state ...

        6. 217B.Original pack dispensing

        7. 217BA.Original pack dispensing: Northern Ireland

        8. 217C.Original pack dispensing: medicinal products containing a relevant substance

        9. 217CA.Original pack dispensing: medicinal products containing a relevant substance: Northern Ireland

        10. 218.Requirements for prescriptions: approved country health professional

        11. 219.Electronic prescriptions

        12. 219A.Electronic Prescriptions: approved country health professionals

      2. Medicines not subject to general sale

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

      3. General sale medicines

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

        2. 222.Sale of medicinal products from automatic machines

    3. CHAPTER 3 Exemptions

      1. Exemptions relating to supply in specific circumstances

        1. 223.Exemptions for doctors and dentists etc

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

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

        4. 226.Emergency sale etc by pharmacist: pandemic diseases

        5. 226A.Sale etc by a pharmacist in accordance with a serious shortage protocol

        6. 227.Exemption for sale or supply in hospitals

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

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

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

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

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

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

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

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

      2. Exemptions in relation to specific kinds of product

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

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

        3. 237A.Appropriate suppliers of naloxone products

        4. 238.Administration of certain medicines in an emergency

        5. 239.Administration of smallpox vaccine

        6. 240.Radioactive medicinal products

        7. 241.Exemptions in respect of certain herbal remedies

        8. 242.Exemption for medicinal products at high dilution

        9. 243.Exemption for certain homoeopathic medicinal products

      3. Other exemptions

        1. 244.Exemption in cases involving another's default

        2. 245.Exemption in case of forged prescription

        3. 246.Exemption where requirements for prescriptions not met

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

        5. 247A.Protocols relating to coronavirus and influenza vaccinations and immunisations

        6. 248.Exemption for certain collection and delivery arrangements

    4. CHAPTER 4 Miscellaneous provisions, offences and disqualification

      1. Miscellaneous provisions

        1. 249.Restrictions on persons to be supplied with medicinal products

        2. 250.Exceptions to regulation 249

        3. 251.Compliance with standards specified in certain publications

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

        5. 253.Pharmacy records

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

        7. 255.Offences relating to dealings with medicinal products

        8. 255A.Enforcement notices relating to Commission Regulation 2016/161: persons authorised to supply medicinal products to the public

        9. 255B.Exception to Article 25 of Commission Regulation 2016/161: health care institutions

        10. 255C.Offences relating to Commission Regulation 2016/161: management of the repository system

      2. Disqualification

        1. 256.Disqualification on conviction

  14. PART 12A Sale of medicines to the public at a distance

    1. 256ZA.Application of Part

    2. 256A.Interpretation

    3. 256B.Person who may sell medicinal products by information society services

    4. 256C.Notification requirements for sellers of medicinal products at a distance

    5. 256D.Procedure for listing persons who may supply medicinal products at a distance

    6. 256E.Removal of a person’s entry from the list

    7. 256F.Provision of information to the licensing authority

    8. 256G.Grant or refusal to list a person

    9. 256H.Conditions to be met by a person entered on the list

    10. 256I.Power to suspend, vary or remove a person’s entry on the list

    11. 256J.Procedure where the licensing authority proposes to suspend, vary or remove a person’s entry on the list

    12. 256K.Suspension of a person’s entry on the list in cases of urgency

    13. 256L.Variation of a person’s entry on the list on the application of that person

    14. 256M.Offences: breach of regulations and false information

    15. 256N.Penalties

  15. PART 13 Packaging and leaflets

    1. CHAPTER 1

      1. Requirements for packaging and package leaflets relating to medicinal products

        1. 257.Packaging requirements: general

        2. 257A.Packaging Requirements: medicinal products required to bear safety features

        3. 257B.Transitional Arrangements

        4. 257C.Packaging requirements: advanced therapy medicinal products

        5. 257D.Guidance as to packaging and package leaflets

        6. 257E.Regulation-making power as to certain forms of labelling

        7. 258.Packaging requirements: specific provisions

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

        9. 260.Package leaflets

        10. 261.Use of pictures and symbols etc

        11. 262.Labelling requirements for radionuclides

        12. 263.Leaflets relating to radionuclides

        13. 264.Homoeopathic medicines

        14. 265.Additional requirements for traditional herbal medicinal products

        15. 266.Language requirements etc

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

      2. Enforcement and offences

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

        2. 268A. Offence relating to packaging and package leaflets in Northern Ireland: holder of authorisation etc

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

        4. 269A. Offences relating to packaging and package leaflets in Northern Ireland: other persons

        5. 270.Non-compliance with requirements of this Part

        6. 271.Offences: penalties

    2. CHAPTER 2

      1. Requirements relating to child safety

        1. 272.Interpretation

        2. 273.Child resistant containers for regulated medicinal products

        3. 274.Exemptions from regulation 273

        4. 275.Colouring of aspirin and paracetamol products for children

        5. 276.Offences

  16. PART 14 Advertising

    1. CHAPTER 1 General

      1. 277.Interpretation

      2. 278.Functions of the Ministers

    2. CHAPTER 2 Requirements relating to advertising

      1. General

        1. 279.Products without a marketing authorisation etc

        2. 280.General principles

        3. 281.Duties of authorisation holders and registration holders

      2. Advertising to the public

        1. 282.Application of regulations 283 to 292

        2. 283.Products for the purpose of inducing abortions

        3. 284.Prescription only medicines

        4. 284A. Medicines with differing classification status in Great Britain and Northern Ireland

        5. 285.Narcotic and psychotropic substances

        6. 286.Material relating to diagnosis

        7. 287.Material about effects of medicinal product

        8. 288.Material about status of medicinal product

        9. 289.Recommendations by scientists etc

        10. 290.Advertisements directed at children

        11. 291.Form and content of advertisement

        12. 291A.Campaigns relating to the suspected or confirmed spread of pathogenic agents etc.

        13. 292.Exception for approved vaccination campaigns

      3. Prohibition of supply to the public for promotional purposes

        1. 293.Prohibition of supply to the public for promotional purposes

      4. Advertising to persons qualified to prescribe or supply etc

        1. 294.General requirements

        2. 295.Abbreviated advertisements

        3. 296.Exception for advertisements intended as a reminder

        4. 297.Written material accompanying promotions

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

        6. 299.Medical sales representatives

        7. 300.Inducements and hospitality

      5. Homoeopathic medicinal products

        1. 301.Advertisements for registered homoeopathic medicinal products

      6. Traditional herbal medicinal products

        1. 302.Advertisements for traditional herbal medicinal products

      7. Offences

        1. 303.Offences

    3. CHAPTER 3 Monitoring of Advertising

      1. Scrutiny by Ministers

        1. 304.Requirement to provide copy advertisement

        2. 305.Invitation to make representations about compatibility

        3. 306.Decision about compatibility

        4. 307.Corrective statement

        5. 308.Offences

      2. Complaints to Ministers

        1. 309.Complaints to Ministers: duty to consider

        2. 310.Complaints to Ministers: power to refer

      3. Injunctions

        1. 311.Application for injunction

        2. 312.Application for injunction: accuracy of factual claim

        3. 313.Grant of injunction: publication of decision and corrective statement

      4. Complaints to OFCOM

        1. 314.Complaints to OFCOM

      5. General

        1. 315.Public interest etc

        2. 316.Civil proceedings

  17. PART 15 British Pharmacopoeia

    1. 317.British Pharmacopoeia and compendia

    2. 318.Lists of names

    3. 319.Other documents

    4. 320.Supplementary provisions

    5. 321.Specified publications

  18. PART 16 Enforcement

    1. 322.Validity of decisions and proceedings

    2. 323.Enforcement in England, Wales and Scotland

    3. 324.Enforcement in Northern Ireland

    4. 325.Rights of entry

    5. 326.Application for warrant

    6. 327.Powers of inspection, sampling and seizure

    7. 328.Regulation 327: supplementary

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

    9. 330.Analysis of samples: other cases

    10. 331.Findings and reports of inspections

    11. 331A.Guidelines on inspections

    12. 332.Restrictions on disclosure of information

    13. 333.Protection for inspectors

    14. 334.Supplementary provisions and offences

  19. PART 17 Miscellaneous and general

    1. Provisions relating to offences

      1. 335.Contravention due to fault of another person

      2. 336.Warranty as defence

      3. 337.Offences in relation to warranties and certificates

      4. 338.Offences by bodies corporate and partnerships

    2. Prosecutions

      1. 339.Prosecutions

    3. General

      1. 340.Presumptions

      2. 341.Decisions under these Regulations

      3. 342.Time limits for provision of information etc

      4. 343.Service of documents

      5. 344.Payment of expenses by Ministers

      6. 344A.Modifications to deal with serious shortages

      7. 344B.Regulation making powers

    4. Immunity from civil liability

      1. 345.Immunity from civil liability

      2. 345A.Obligation on licensing authority to maintain list of medicinal products to which derogations have applied

    5. Review

      1. 346.Review

    6. Transitional provisions, savings, amendments, repeals and revocations

      1. 347.Transitional provisions and savings

      2. 347A.Transitional provision in relation to EU exit

      3. 348.Amendments to existing law

      4. 349.Repeals and revocations

  20. Signature

  21. SCHEDULES

    1. SCHEDULE 1

      Further provisions for classification of medicinal products

      1. PART 1 Descriptions of certain medicinal products to be available only on prescription

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

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

      2. PART 2 Descriptions of certain medicinal products to be available only from a pharmacy

        1. 3.The following medicinal products shall be available only from a...

        2. 4.The following medicinal products shall be available only from a...

        3. 5.A medicinal product shall be available only from a pharmacy...

    2. SCHEDULE 2

      Supplementary provision relating to advisory bodies and expert advisory groups

      1. Terms of appointment

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

        2. 2.(1) A member of an advisory body, other than its...

        3. 3.(1) The person appointed to chair an expert advisory group...

        4. 4.(1) This paragraph applies to a member of an expert...

      2. Facilities and proceedings

        1. 5.The Ministers must provide each advisory body with such staff,...

        2. 6.The validity of any proceedings of an advisory body or...

        3. 7.(1) An advisory body may, subject to approval by the...

      3. Payment and expenses

        1. 8.The Ministers may pay to the members of each advisory...

        2. 9.The Ministers must defray any expenses incurred with their approval...

        3. 10.If an action is brought against a person arising out...

        4. 11.Paragraphs 8 to 10 shall have effect in relation to...

      4. Status

        1. 12.An advisory body or expert advisory group is not to...

    3. SCHEDULE 2A

      Modifications of Commission Directive 2003/94/EC

    4. SCHEDULE 3

      Applications for licences under Part 3

      1. Manufacturer's licences

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

      2. Manufacturers' licence relating to import

        1. 2.(1) This paragraph applies to an application for a manufacturer's...

      3. Wholesale dealer's licences

        1. 3.(1) This paragraph applies to an application for a wholesale...

      4. All licences

        1. 4.(1) If an application does not include information or other...

    5. SCHEDULE 4

      Standard provisions of licences under Part 3

      1. PART 1 Manufacturer's licence relating to manufacture and assembly

        1. 1.The provisions of this Part are standard provisions of a...

        2. 2.The licence holder must place the quality control system referred...

        3. 3.The licence holder may use a contract laboratory pursuant to...

        4. 4.The licence holder must provide such information as may be...

        5. 5.The licence holder must inform the licensing authority of any...

        6. 6.The licence holder must— (a) keep readily available for inspection...

        7. 7.The licence holder must keep readily available for examination by...

        8. 8.Where the licence holder has been informed by the licensing...

        9. 9.The licence holder must ensure that tests for determining conformity...

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

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

        12. 12.The licence holder must keep readily available for examination by...

        13. 13.Where— (a) animals are used in the production of medicinal...

        14. 14.The licence holder must take all reasonable precautions and exercise...

        15. 14A.A licence holder— (a) in Great Britain may only supply...

        16. 14B.A licence holder may only manufacture or assemble EAMS medicinal...

      2. PART 2 Manufacturer's licence relating to the import of medicinal products from a state other than an EEA State / Country other than an Approved Country for Import

        1. 15.The provisions of this Part are standard provisions of a...

        2. 15A.The provisions of this Part are standard provisions of a...

        3. 16.The licence holder must place the quality control system referred...

        4. 17.The licence holder may use a contract laboratory pursuant to...

        5. 18.The licence holder must provide such information as may be...

        6. 19.The licence holder must— (a) keep readily available for inspection...

        7. 20.Where the licence holder has been informed by the licensing...

        8. 21.The licence holder must ensure that any tests for determining...

        9. 22.(1) Where and in so far as the licence relates...

        10. 23.The licence holder must take all reasonable precautions and exercise...

        11. 23ZA.The licence holder in Great Britain must take all reasonable...

        12. 23A.A licence holder— (a) in Great Britain may only supply...

        13. 23B.A licence holder may only import EAMS medicinal products if...

      3. PART 3 Manufacturer's licence relating to exempt advanced therapy medicinal products

        1. 24.The provisions of paragraphs 25 to 27 are incorporated as...

        2. 25.The licence holder must ensure that the immediate packaging of...

        3. 26.The licence holder must ensure that the package leaflet of...

        4. 27.The licence holder must keep the data referred to in...

      4. PART 4 Wholesale dealer's licence

        1. All wholesale dealer's licences

          1. 28.The provisions of this Part are standard provisions of a...

          2. 29.The licence holder must not use any premises for the...

          3. 30.The licence holder must provide such information as may be...

          4. 31.The licence holder must take all reasonable precautions and exercise...

        2. Wholesale dealer's licence relating to special medicinal products

          1. 32.The provisions of paragraphs 33 to 42 are incorporated as...

          2. 33.Where and in so far as the licence relates to...

          3. 33A.A licence holder may only import EAMS medicinal products if...

          4. 34.No later than 28 days prior to each importation of...

          5. 35.The licence holder may not import the special medicinal product...

          6. 36.The licence holder may import the special medicinal product referred...

          7. 37.Where the licence holder sells or supplies special medicinal products...

          8. 38.The licence holder must not, on any one occasion, import...

          9. 39.The licence holder must inform the licensing authority immediately of...

          10. 40.The licence holder must not publish any advertisement, catalogue, or...

          11. 41.The licence holder must cease importing or supplying a special...

          12. 41A.A licence holder— (a) in Great Britain may only supply...

          13. 42.In this Part— “British approved name” means the name which...

        3. Wholesale dealer's licence relating to exempt advanced therapy medicinal products

          1. 43.The provisions of paragraph 44 are incorporated as additional standard...

          2. 44.The licence holder shall keep the data referred to in...

    6. SCHEDULE 5

      Review upon oral representations

      1. Application of this Schedule

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

      2. Appointment of reviewers

        1. 2.(1) The licensing authority must— (a) appoint a panel of...

      3. Procedure before hearing

        1. 3.(1) The applicant must supply the reviewers with a written...

      4. Procedure at hearing

        1. 4.(1) Both the applicant and the licensing authority may make...

      5. Procedure following hearing

        1. 5.(1) After the hearing the reviewers must provide a report...

    7. SCHEDULE 6

      Manufacturer's and wholesale dealer's licences for exempt advanced therapy medicinal products

      1. PART 1 Manufacturer's licences

        1. 1.The requirements in paragraphs 2 to 12 apply to a...

        2. 2.The licence holder must inform the licensing authority of any...

        3. 3.The licence holder must ensure, if using human cells or...

        4. 4.The licence holder must ensure that any human tissue or...

        5. 5.The licence holder must ensure that any blood or blood...

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

        7. 7.The licence holder must, at the written request of the...

        8. 8.The licence holder must establish and maintain a system ensuring...

        9. 9.The licence holder must, subject to paragraph 27 of Schedule...

        10. 10.The licence holder must secure that the data referred to...

        11. 11.The licence holder must, where an exempt advanced therapy medicinal...

        12. 12.The licence holder must not import or export any exempt...

      2. PART 2 Wholesale dealer's licences

        1. 13.The requirements in paragraphs 14 to 20 apply to a...

        2. 14.The licence holder must obtain supplies of exempt advanced therapy...

        3. 15.The licence holder must distribute an exempt advanced therapy medicinal...

        4. 16.The licence holder must establish and maintain a system ensuring...

        5. 17.The licence holder must inform the licensing authority of any...

        6. 18.The licence holder must, subject to paragraph 44 of Schedule...

        7. 19.The licence holder must secure that the data referred to...

        8. 20.The licence holder must not import or export any exempt...

    8. SCHEDULE 7

      Qualified persons

      1. PART 1 Qualification requirements for qualified person

        1. 1.A person must satisfy the requirements in paragraphs 2 and...

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

        3. 3.A qualification satisfies the requirements of this Part if it...

        4. 4.(1) A course should include at least the following core...

        5. 5.If the course referred to in paragraph 3 is followed...

        6. 6.If two university courses, or courses recognised as of university...

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

        8. 8.(1) The person must (subject to sub-paragraph (2)) have at...

      2. PART 2 Qualified persons with long experience

        1. 9.(1) This paragraph applies to a person who has acted...

        2. 10.(1) This paragraph applies to a person who—

        3. 11.If a person to whom paragraph 10 applies acquired the...

      3. PART 3 Obligations of qualified person

        1. 12.(1) In Great Britain, the qualified person is responsible for...

        2. 12A.(1) In Northern Ireland, the qualified person is responsible for...

        3. 13.(1) This paragraph applies in Northern Ireland where—

        4. 14.(1) This paragraph applies where— (a) medicinal products are imported...

        5. 15.(1) The qualified person is responsible for ensuring, in relation...

    9. SCHEDULE 7A

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

      1. 1.The name and address of the applicant.

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

      3. 3.The address of each of the premises where any operations...

      4. 4.The address of any premises not mentioned by virtue of...

      5. 5.The address of each of the premises where active substances...

      6. 6.The address of each of the premises where any testing...

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

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

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

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

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

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

      13. 13.Details of the operations to which the registration relates, including...

      14. 14.A statement of the facilities and equipment available at each...

      15. 15.A statement as to whether the particular active substances are...

      16. 16.A separate statement in respect of each of the premises...

      17. 17.A statement of the authority conferred on the person responsible...

      18. 18.A description of the arrangements for the identification and storage...

      19. 19.A description of the arrangements for the identification and storage...

      20. 20.A description of the arrangements at each of the premises...

      21. 21.A description of the arrangements for maintaining—

      22. 22.A description of the arrangements for keeping reference samples of—...

      23. 23.Where the application relates to active substances intended for use...

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

    10. SCHEDULE 8

      Material to accompany an application for a UK marketing authorisation

      1. PART 1 General requirements

        1. 1.The name or corporate name and permanent address of the...

        2. 2.The name of the medicinal product. This may be—

        3. 3.Qualitative and quantitative particulars of the constituents of the medicinal...

        4. 4.An evaluation of the potential environmental risks posed by the...

        5. 5.A description of the methods of manufacturing the medicinal product....

        6. 6.The therapeutic indications and contra-indications for the medicinal product and...

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

        8. 8.The reasons for any precautionary and safety measures to be...

        9. 9.A description of the control methods employed by the manufacturer....

        10. 9A.A written confirmation that the manufacturer of the medicinal product...

        11. 10.The results of the following in relation to the medicinal...

        12. 11.A detailed summary of those results prepared and signed by...

        13. 12.A summary of the applicant's pharmacovigilance system which shall include...

        14. 13.The risk management plan, together with a summary, that—

        15. 14.Where any clinical trials have been carried out outside the...

        16. 15.A summary of the product characteristics for the medicinal product...

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

        18. 17.A document showing that the manufacturer of the medicinal product...

        19. 18.Where— (a) in the case of a UKMA(NI) or a...

        20. 19.Where an authorisation for the medicinal product to be placed...

        21. 20.Where , in the case of a medicinal product for...

        22. 21.Where an authorisation for the medicinal product to be placed...

        23. 22.In the case of a medicinal product for sale or...

      2. PART 2 Summary of the product characteristics

        1. 23.For medicinal products included on the list referred to—

        2. 24.The name of the medicinal product followed by its strength...

        3. 25.The qualitative and quantitative composition, using the usual common name...

        4. 25A.In the case of an advanced therapy medicinal product for...

        5. 26.The pharmaceutical form of the medicinal product.

        6. 27.Clinical particulars in relation to the medicinal product, covering—

        7. 28.The pharmacological properties of the medicinal product, covering—

        8. 29.Pharmaceutical particulars in relation to the medicinal product, covering—

        9. 30.The holder of the UK marketing authorisation.

        10. 31.The number of the UK marketing authorisation.

        11. 32.The date of the first UK marketing authorisation or, where...

        12. 33.The date of any revisions of the text of the...

        13. 34.For radiopharmaceuticals, full details of internal radiation dosimetry.

        14. 35.For radiopharmaceuticals, additional detailed instructions for extemporaneous preparation and quality...

        15. 36.In the case of an advanced therapy medicinal product for...

    11. SCHEDULE 8A

      Material to accompany an application for a parallel import licence

      1. 1.The name or corporate name and permanent address of the...

      2. 2.The name of the medicinal product. This may be—

      3. 3.Details of the product to be imported if requested by...

      4. 4.Details of the UK reference product.

      5. 5.If requested by the licensing authority, an evaluation of the...

      6. 6.If requested by the licensing authority, a summary of the...

      7. 7.If requested by the licensing authority, the risk management plan,...

      8. 8.If requested by the licensing authority, a summary of the...

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

    12. SCHEDULE 8B

      Modifications of Annex I to the 2001 Directive

    13. SCHEDULE 8C

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

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

      2. 2.A copy of all material submitted in support of the...

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

    14. SCHEDULE 9

      Undertakings by non- United Kingdom manufacturers

      1. 1.The manufacturer must provide and maintain such staff, premises and...

      2. 2.The manufacturer must provide and maintain such staff, premises, equipment...

      3. 3.The manufacturer must provide and maintain a designated quality control...

      4. 4.The manufacturer must conduct all manufacture and assembly operations in...

      5. 5.The manufacturer must maintain an effective pharmaceutical quality assurance system...

      6. 6.Where animals are used in the production of any medicinal...

      7. 7.The manufacturer must make such adequate and suitable arrangements as...

      8. 8.The manufacturer must inform the holder of the UK marketing...

      9. 9.(1) The manufacturer shall keep readily available for inspection by...

      10. 10.The manufacturer must keep readily available for examination by a...

      11. 11.(1) The manufacturer must implement a system for recording and...

      12. 12.The manufacturer must inform the holder of the UK marketing...

    15. SCHEDULE 9A

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

      1. 1.Prevalence of a condition in Great Britain

      2. 2.Potential for return on investment

      3. 3.Existence of other methods of diagnosis, prevention or treatment

      4. 4.Increased safety or effectiveness and clinical superiority

      5. 5.(1) This paragraph applies for the purposes of the definition...

      6. 6.(1) This paragraph applies for the purposes of the definition...

      7. 7.(1) This paragraph applies for the purposes of the definition...

      8. 8.(1) This paragraph applies for the purposes of the definition...

    16. SCHEDULE 10

      National homoeopathic products

      1. Meaning of “national homoeopathic product”

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

      2. General requirements for application

        1. 2.(1) An application for the grant of a UK marketing...

      3. Requirement to submit safety data

        1. 3.(1) The applicant must submit data as to the safety...

      4. Exceptions to requirement to submit safety data

        1. 4.(1) The applicant does not need to submit data as...

      5. Requirement to submit efficacy data

        1. 5.(1) The applicant must submit data as to the efficacy...

    17. SCHEDULE 10A

      Variations to a UK marketing authorisation

      1. 1.Interpretation

      2. 2.Classification of variations

      3. 3.Licensing authority recommendation on unclassified variations

      4. 4.Variations leading to the revision of product information

      5. 5.Grouping of variations

      6. 6.Notification procedure for minor variations of type IA

      7. 7.Notification procedure for minor variations of type IB

      8. 8.Prior approval procedure for major variations of type II

      9. 9.Elements to be submitted

      10. 10.Measures to close the procedures specified in paragraphs 6 to 8

      11. 11.Extensions of marketing authorisations

      12. 12.Human influenza vaccines

      13. 13.Pandemic situation with respect to human influenza

      14. 14.Urgent safety restrictions

      15. 15.Amendments to the decision granting the marketing authorisation

      16. 16.Implementation of variations

      17. 17.Continuous monitoring

    18. SCHEDULE 11

      Advice and representations

      1. PART 1 General procedures

        1. Application of this Part

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

        2. Requirement to consult the appropriate committee

          1. 2.(1) The licensing authority must consult the appropriate committee if...

        3. Exceptions to requirement to consult

          1. 3.(1) Paragraph 2 does not apply to a proposal to...

          2. 4.(1) Paragraph 2 does not apply to a proposal to...

        4. Provisional opinion against authorisation

          1. 5.(1) If the appropriate committee is consulted under paragraph 2(1)...

        5. Opportunity to make representations

          1. 6.(1) An applicant or holder notified under paragraph 5 may,...

        6. Written representations

          1. 7.(1) If the applicant or holder requests the opportunity to...

        7. Oral representations

          1. 8.(1) If the applicant or holder requests the opportunity to...

        8. Other decisions of the appropriate committee

          1. 9.(1) This paragraph applies if the applicant or holder—

        9. Decision of licensing authority

          1. 10.(1) After receiving the appropriate committee's report under paragraph 7...

        10. Right to review after paragraph 10 notification

          1. 11.(1) A person to whom a notification is given under...

        11. Licensing authority decisions in other cases

          1. 12.(1) This paragraph applies if the appropriate committee has not...

        12. Right to review or representations after paragraph 12 notification

          1. 13.(1) A person to whom a notification is given under...

      2. PART 1A Paediatric Decisions

        1. 13A.Application of this Part

        2. 13B.Opportunity to make representations

        3. 13C.Written representations

        4. 13D.Oral representations

        5. 13E.Other decisions of the appropriate committee

        6. 13F.Decision of licensing authority

        7. 13G.Right to review after paragraph 13F notification

      3. PART 2 Type II variation applications, complex variation applications and new excipient variation applications

        1. Application of this Part

          1. 14.This Part applies— (a) to an application (a “Type II...

          2. 15.(1) In paragraph 14(b)(i) “complex variation application” means an application...

          3. 16.(1) In paragraph 14(b)(ii) “new excipient variation application” means an...

          4. 17.In relation to an application for a UKMA(NI) or THR(NI),...

        2. Opportunity to make representations

          1. 18.(1) This paragraph applies if the licensing authority notifies the...

        3. Written representations

          1. 19.(1) If the applicant requests the opportunity to make written...

        4. Oral representations

          1. 20.(1) If the applicant requests the opportunity to make oral...

        5. Other decisions of the appropriate committee

          1. 21.(1) This paragraph applies if the applicant—

        6. Decision of licensing authority following report

          1. 22.(1) After receiving the appropriate committee's report under paragraph 19...

        7. Right to review after paragraph 22 notification

          1. 23.(1) This paragraph applies if the licensing authority notifies the...

      4. PART 3 Referral to the appropriate committee for traditional herbal registrations

        1. Application of this Part

          1. 24.(1) This Part applies if the licensing authority proposes to...

        2. Opportunity to make representations

          1. 25.(1) The licensing authority must notify the applicant of the...

        3. Written representations

          1. 26.(1) If the applicant requests the opportunity to make written...

        4. Oral representations

          1. 27.(1) If the applicant requests the opportunity to make oral...

        5. Other decisions of the appropriate committee

          1. 28.(1) This paragraph applies if the applicant—

        6. Decision of licensing authority following report

          1. 29.(1) After receiving the appropriate committee's report under paragraph 26...

        7. Right to review after paragraph 29 notification

          1. 30.(1) This paragraph applies if the licensing authority notifies the...

      5. PART 4 Exceptions to Schedule

        1. 31.This Schedule does not apply to an application for the...

        2. 32.This Schedule does not apply to an application for the...

        3. 33.This Schedule ceases to apply if at any time the...

        4. 34.This Schedule does not apply to an application for a...

        5. 35.This Schedule does not apply to an application for a...

        6. 36.This Schedule does not apply if the application or proposal...

        7. 37.This Schedule does not apply if the application or proposal...

        8. 38.This Schedule does not apply if the application or proposal...

        9. 39.This Schedule does not apply if— (a) the licensing authority...

    19. SCHEDULE 12

      Material to accompany an application for a traditional herbal registration

      1. PART 1 General requirements

        1. 1.The name or corporate name and permanent address of the...

        2. 2.The name of the medicinal product. This may be—

        3. 3.Qualitative and quantitative particulars of the constituents of the medicinal...

        4. 4.An evaluation of the potential environmental risks posed by the...

        5. 5.A description of the methods of manufacturing the medicinal product....

        6. 6.The therapeutic indications and contra-indications for the medicinal product and...

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

        8. 8.The reasons for any precautionary and safety measures to be...

        9. 9.A description of the control methods employed by the manufacturer....

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

        11. 11.A detailed summary of those results prepared and signed by...

        12. 12.A summary of the product characteristics for the medicinal product...

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

        14. 14.A document showing that the manufacturer of the medicinal product...

        15. 15.Where the medicinal product consists of a combination of one...

        16. 16.Details of any authorisation or registration obtained by the applicant...

        17. 17.Details of any decision in a country other than the...

        18. 18.Bibliographical or expert evidence of the traditional use of the...

        19. 19.A bibliographic review of safety data.

        20. 20.An expert report on safety.

      2. PART 2 Summary of the product characteristics

        1. 21.For medicinal products included on the list referred to in...

        2. 22.The name of the medicinal product followed by its strength...

        3. 23.The qualitative and quantitative composition, using the usual common name...

        4. 24.The pharmaceutical form of the medicinal product.

        5. 25.The pharmacological properties of the medicinal product, covering—

        6. 26.Pharmaceutical particulars of the medicinal product, covering—

        7. 27.The holder of the traditional herbal registration.

        8. 28.The number of the traditional herbal registration.

        9. 29.The date of the first traditional herbal registration or, where...

        10. 30.The date of any revisions of the text of the...

    20. SCHEDULE 12A

      Further provision as to the performance of pharmacovigilance activities

      1. PART 1 Pharmacovigilance system master file

        1. 1.Structure of the pharmacovigilance system master file

        2. 2.Content of the pharmacovigilance system master file

        3. 3.Content of the Annex to the pharmacovigilance system master file

        4. 4.Maintenance of the pharmacovigilance system master file

        5. 5.Form of the documents contained in the pharmacovigilance system master file

        6. 6.Subcontracting

        7. 7.Availability and location of the pharmacovigilance system master file

      2. PART 2 Minimum requirements for the quality systems for the performance of pharmacovigilance activities by the licensing authority and holders

        1. 8.Quality system

        2. 9.Performance indicators

      3. PART 3 Minimum requirements for the quality systems for the performance of pharmacovigilance activities by holders

        1. 10.Management of human resources

        2. 11.Compliance management

        3. 12.Record management and data retention

        4. 13.Audit

      4. PART 4 Minimum requirements for the quality systems for the performance of pharmacovigilance activities by the licensing authority

        1. 14.Management of human resources

        2. 15.Compliance management

        3. 16.Record management and data retention

        4. 17.Audit

      5. PART 5 Use of terminology, formats and standards

        1. 18.Use of internationally agreed terminology, formats and standards

      6. PART 6 Transmission of reports of suspected adverse reactions

        1. 19.Individual case safety reports

        2. 20.Content of the individual case safety report

        3. 21.Format of electronic transmission of suspected adverse reactions

      7. PART 7 Risk management plans

        1. 22.Content of the risk management plan

        2. 23.Summary of the risk management plan

        3. 24.Updates of the risk management plan

        4. 25.Format of the risk management plan

      8. PART 8 Periodic safety update reports

        1. 26.Content of periodic safety update reports

        2. 27.Format of periodic safety update reports

      9. PART 9 Post-authorisation safety studies

        1. 28.Scope and interpretation

        2. 29.Obligations as to post-authorisation safety studies

        3. 30.Format of the study protocol

        4. 31.Format of the abstract of the final study report

        5. 32.Format of the final study report

    21. SCHEDULE 13

      Prescription only medicines for which community practitioner nurse prescribers are appropriate practitioners

      1. Co-danthramer Capsules NPF Co-danthramer Capsules Strong NPF Co-danthramer Oral Suspension...

    22. SCHEDULE 14

      Prescription etc by supplementary prescribers: particulars of clinical management plan

      1. A clinical management plan must contain the following particulars—

    23. SCHEDULE 15

      Requirements for specific products subject to general sale

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

      2. 2.A medicinal product that contains ibuprofen and that is in...

    24. SCHEDULE 16

      Patient group directions

      1. PART 1 Particulars to be included in a patient group direction

        1. 1.The period during which the direction is to have effect....

        2. 2.The description or class of medicinal product to which the...

        3. 3.The clinical situations which medicinal products of that description or...

        4. 4.Whether there are any restrictions on the quantity of medicinal...

        5. 5.The clinical criteria under which a person is to be...

        6. 6.Whether any class of person is excluded from treatment under...

        7. 7.Whether there are circumstances in which further advice should be...

        8. 8.The pharmaceutical form or forms in which medicinal products of...

        9. 9.The strength, or maximum strength, at which medicinal products of...

        10. 10.The applicable dosage or maximum dosage.

        11. 11.The route of administration.

        12. 12.The frequency of administration.

        13. 13.Any minimum or maximum period of administration applicable to medicinal...

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

        15. 15.Whether there is any follow up action to be taken...

        16. 16.Arrangements for referral for medical advice.

        17. 17.Details of the records to be kept of the supply,...

      2. PART 2 Persons on whose behalf a patient group Direction must be signed

      3. PART 3 Persons by whom or on whose behalf a patient group direction used as described in regulation 234 must be signed

      4. PART 4 Classes of individuals by whom supplies may be made

        1. Pharmacists. Registered chiropodists and podiatrists. Registered dental hygienist. Registered dental...

    25. SCHEDULE 17

      Exemption for sale, supply or administration by certain persons

      1. PART 1 Exemption from restrictions on sale and supply of prescription only medicines

      2. PART 2 Exemption from the restriction on supply of prescription only medicines

      3. PART 3 Exemptions from the restriction on administration of prescription only medicines

      4. PART 4 Exemptions from the restrictions in regulations 220 and 221 for certain persons who sell, supply, or offer for sale or supply certain medicinal products

      5. PART 5 Exemptions from the restrictions in regulations 220 and 221 for certain persons who supply certain medicinal products

    26. SCHEDULE 18

      Substances that may not be sold or supplied by a pharmacist without a prescription in reliance on regulation 225

      1. Ammonium bromide Calcium bromide Calcium bromidolactobionate Embutramide Fencamfamin hydrochloride Fluanisone...

    27. SCHEDULE 19

      Medicinal products for parenteral administration in an emergency

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

    28. SCHEDULE 20

      Herbal medicinal products specified for the purposes of regulation 241

      1. PART 1

      2. PART 2

    29. SCHEDULE 21

      Medicinal products at high dilutions

      1. PART 1 Dilutions of unit preparations diluted to at least one part in a thousand (3x)

      2. PART 2 Dilutions of unit preparations diluted to at least one part in a million (6x)

      3. PART 3 Dilutions of unit preparations diluted to at least one part in ten (1x)

      4. PART 4 Dilutions of unit preparations diluted to at least one part in ten (1x) for external use

    30. SCHEDULE 22

      Classes of person for the purposes of regulation 249

      1. Doctors

      2. Dentists

      3. Persons lawfully conducting a retail pharmacy business within the meaning...

      4. Authorities or persons carrying on the business of—

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

      6. Ministers of the Crown and Government departments.

      7. Scottish Ministers.

      8. Welsh Ministers.

      9. A Northern Ireland Minister.

      10. An NHS trust.

      11. An NHS foundation trust.

      12. The Common Services Agency.

      13. A health authority or a special health authority.

      14. . . . . . . . . . ....

      15. A person other than an excepted person who carries on...

      16. A person other than an excepted person who carries on...

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

    31. SCHEDULE 23

      Particulars in pharmacy records

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

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

      3. 3.Where the sale or supply is in pursuance of a...

      4. 4.Where the sale or supply of a prescription only medicine...

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

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

    32. SCHEDULE 24

      Packaging information requirements

      1. PART 1 Outer and immediate packaging

        1. 1.The name of the medicinal product.

        2. 2.The strength and pharmaceutical form of the product.

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

        4. 4.Where the product contains up to three active substances, the...

        5. 5.A statement of the active substances in the product, expressed...

        6. 6.The pharmaceutical form and the contents by weight, by volume...

        7. 7.A list of— (a) where the product is injectable or...

        8. 8.The method of administration of the product and if necessary...

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

        10. 10.A warning that the product must be stored out of...

        11. 11.Any special warning applicable to the product.

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

        13. 13.Any special storage precautions relating to the product.

        14. 14.Any special precautions relating to the disposal of an unused...

        15. 15.The name and address of the holder of the UK...

        16. 16.The number of the UK marketing authorisation, EU marketing authorisation...

        17. 17.The manufacturer's batch number.

        18. 18.In the case of a product that is not a...

        19. 18A.In the case of a medicinal product, other than a...

      2. PART 2 Immediate packaging: blister packs

        1. 19.The name of the medicinal product.

        2. 20.The strength and pharmaceutical form of the product.

        3. 21.Where appropriate, whether the product is intended for babies, children...

        4. 22.Where the product contains up to three active substances, the...

        5. 23.The name of the holder of the UK marketing authorisation,...

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

        7. 25.The manufacturer's batch number.

      3. PART 3 Immediate packaging: small packages

        1. 26.The name of the medicinal product.

        2. 27.The strength and pharmaceutical form of the product.

        3. 28.Where appropriate, whether the product is intended for babies, children...

        4. 29.Where the product contains up to three active substances, the...

        5. 30.The method of administration of the product and if necessary...

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

        7. 32.The manufacturer's batch number.

        8. 33.The contents of the packaging by weight, by volume or...

      4. PART 4 Outer and immediate packaging: advanced therapy medicinal products for sale or supply in Great Britain only

        1. 34.The name of the advanced therapy medicinal product which is...

        2. 35.Where appropriate, whether the product is intended for babies, children...

        3. 36.The expiry date in clear terms including the year and...

        4. 37.A description of the active substance, expressed qualitatively and quantitatively....

        5. 38.Where the product contains tissues and cells of human or...

        6. 39.The pharmaceutical form and the contents by weight, volume or...

        7. 40.A list of excipients, including preservative systems.

        8. 41.The method of use, application, administration or implantation and, if...

        9. 42.A special warning that the product is to be stored...

        10. 43.Any special warning necessary for the particular product.

        11. 44.Any special storage precautions.

        12. 45.Specific precautions relating to the disposal of the unused product...

        13. 46.The name and address of the holder of the UK...

        14. 47.The UK marketing authorisation number.

        15. 48.The manufacturer's batch number.

        16. 49.The unique donation code assigned by a tissue establishment pursuant...

        17. 50.Where the exempt advanced therapy medicinal product is for autologous...

      5. PART 5 Immediate packaging: blister packs and small packaging (advanced therapy medicinal products for sale or supply in Great Britain only)

        1. 51.The information specified in Part 2.

        2. 52.The unique donation code assigned by a tissue establishment pursuant...

        3. 53.Where the exempt advanced therapy medicinal product is for autologous...

    33. SCHEDULE 25

      Packaging requirements: specific provisions

      1. PART 1 Medicines on prescription

        1. 1.Where the product is to be administered to a particular...

        2. 2.The name and address of the person who sells or...

        3. 3.The date on which the product is sold or supplied....

        4. 4.Unless paragraph 5, applies, such of the following particulars as...

        5. 5.This paragraph applies if the pharmacist, in the exercise of...

        6. 6.Where paragraph 5 applies, the pharmacist may include such particulars,...

      2. PART 2 Transport, delivery and storage

        1. 7.Any special requirements for the storage and handling of the...

        2. 8.The expiry date of the product.

        3. 9.The manufacturer's batch number.

      3. PART 3 Pharmacy and prescription only medicines

        1. 10.Paragraph 11 applies if a pharmacy medicine is—

        2. 11.Where this paragraph applies, the capital letter “P” within a...

        3. 12.Paragraph 13 applies if a prescription only medicine is—

        4. 13.Where this paragraph applies, the capital letters “POM” within a...

      4. PART 4 Medicines containing paracetamol

        1. 14.If the product contains paracetamol, except where the name of...

        2. 15.If the product contains paracetamol the words “Do not take...

        3. 16.If the product contains paracetamol, unless the product is wholly...

        4. 17.If the product contains paracetamol and is wholly or mainly...

        5. 18.If the product is required by this Part of this...

    34. SCHEDULE 26

      Packaging requirements: special provisions

      1. PART 1 Supply by doctors, dentists, nurses and midwives

        1. 1.Where the product is to be administered to a particular...

        2. 2.The name and address of the person who sells or...

        3. 3.The date on which the product is sold or supplied....

        4. 4.Such of the following particulars as the person under whose...

      2. PART 2 Pharmacy exceptions

        1. 5.Where the product is to be administered to a particular...

        2. 6.The name and address of the person who sells or...

        3. 7.The date on which the product is sold or supplied....

        4. 8.Where the product is prescribed by an appropriate practitioner, such...

        5. 9.This paragraph applies if a pharmacist, in the exercise of...

        6. 10.Where paragraph 9 applies, the pharmacist may include such particulars,...

        7. 11.Where the product is not prescribed by an appropriate practitioner,...

    35. SCHEDULE 27

      Package leaflets

      1. PART 1 General requirements

        1. 1.The name of the medicinal product.

        2. 2.The strength and pharmaceutical form of the product.

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

        4. 4.Where the product contains up to three active substances, the...

        5. 5.The pharmaco-therapeutic group, or type of activity, of the product,...

        6. 6.The product's therapeutic indications.

        7. 7.A list of— (a) contra-indications; (b) appropriate precautions for use;...

        8. 8.The list mentioned in paragraph 7 must—

        9. 9.Instructions for proper use of the product including in particular—...

        10. 10.A description of the adverse reactions which may occur in...

        11. 11.A reference to the expiry date printed on the packaging...

        12. 12.Where the product is authorised for sale or supply in...

        13. 13.For medicinal products included in the list referred to in...

        14. 14.A standardised text relating to adverse event reporting in accordance...

        15. 15.The date on which the package leaflet was last revised....

      2. PART 2 Paracetamol

        1. 16.If a medicinal product contains paracetamol, unless the product is...

        2. 17.If a medicinal product contains paracetamol and is wholly or...

      3. Part 3 Advanced therapy medicinal products for sale or supply in Great Britain only

        1. 18.The name of the advanced therapy medicinal product.

        2. 19.Where appropriate, whether the product is intended for babies, children...

        3. 20.The common name of the advanced therapy medicinal product.

        4. 21.The therapeutic group, or type of activity, of the product,...

        5. 22.Where the product contains cells or tissues, a description of...

        6. 23.Where the product contains medical devices or active implantable medical...

        7. 24.The product's therapeutic indications.

        8. 25.A list of information which is necessary before the medicinal...

        9. 26.The list mentioned in paragraph 25 must—

        10. 27.Instructions for proper use of the product including in particular—...

        11. 28.A description of the adverse reactions which may occur in...

        12. 29.A reference to the expiry date printed on the packaging...

        13. 30.The date on which the package leaflet was last revised....

    36. SCHEDULE 28

      Labelling requirements for registrable homoeopathic medicinal products

      1. PART 1 Outer and immediate packaging

        1. 1.The scientific name of the stock or stocks (which may...

        2. 2.The name and address of the holder of the certificate...

        3. 3.The method and, if necessary, route of administration.

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

        5. 5.The product's pharmaceutical form.

        6. 6.The contents of the presentation, specified by weight, volume or...

        7. 7.Special storage precautions, if any.

        8. 8.A special warning, if necessary in relation to the product....

        9. 9.The manufacturer's batch number.

        10. 10.The number of the certificate of registration.

        11. 11.The words “homoeopathic medicinal product without therapeutic indications”.

        12. 12.A warning advising the user to consult a doctor if...

      2. PART 2 Blister packs etc contained in outer packaging

        1. 13.The scientific name of the stock or stocks (which may...

        2. 14.The name and address of the holder of the certificate...

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

        4. 16.The manufacturer's batch number.

        5. 17.The words “homoeopathic medicinal product without therapeutic indications”.

      3. PART 3 Small immediate packaging

        1. 18.The scientific name of the stock or stocks (which may...

        2. 19.The name and address of the holder of the certificate...

        3. 20.The method and, if necessary, route of administration.

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

        5. 22.The contents of the presentation, specified by weight, volume or...

        6. 23.The manufacturer's batch number.

        7. 24.The words “homoeopathic medicinal product without therapeutic indications”.

    37. SCHEDULE 29

      Labelling of traditional herbal medicinal products

      1. PART 1 Traditional herbal medicinal products: general

        1. 1.A statement to the effect that the product is a...

        2. 2.A statement that the user should consult a doctor or...

      2. PART 2 Traditional herbal medicinal products not subject to general sale

        1. 3.Subject to the provisions of regulation 265(2), paragraph 4 applies...

        2. 4.Where this paragraph applies, the outer packaging and the immediate...

    38. SCHEDULE 30

      Particulars for advertisements to persons qualified to prescribe or supply

      1. 1.The number of the UK marketing authorisation, EU marketing authorisation,...

      2. 2.The name and address of the holder of the temporary...

      3. 2A.In relation to an advertisement in Great Britain (other than...

      4. 3.The classification of the medicinal product as—

      5. 4.The name of the medicinal product.

      6. 5.A list of the active ingredients of the medicinal product...

      7. 6.One or more of the indications for the medicinal product...

      8. 7.The entries or a succinct statement of the entries (if...

      9. 8.The cost excluding value added tax of—

      10. 9.(1) The particulars specified in paragraph 7 must be printed...

    39. SCHEDULE 31

      Sampling

      1. Introductory

        1. 1.(1) This Schedule has effect where a person authorised by...

      2. Division of sample

        1. 2.The sampling officer must as soon as practicable—

        2. 3.If the sample was purchased by the sampling officer otherwise...

        3. 4.If the sampling officer obtained the sample from a vending...

        4. 5.If the sample is a sample of goods consigned from...

        5. 6.If, in a case not falling within any of paragraphs...

        6. 7.If, in a case not falling within any of paragraphs...

        7. 8.In any case not falling within any of paragraphs 3...

        8. 9.In every case falling within any of paragraphs 3 to...

        9. 10.Unless the sampling officer decides not to submit the sample...

        10. 11.If a sample consists of substances or articles in unopened...

        11. 12.Regulation 343(1)(a) to (d) has effect in relation to supplying...

        12. 13.If after reasonable inquiry the sampling officer is unable to...

      3. Notice to person named on container

        1. 14.(1) This paragraph applies where the sampling officer has obtained...

      4. Analysis or other examination

        1. 15.Where the enforcing authority that authorises the sampling officer is...

        2. 16.Where any other enforcing authority authorises the sampling officer, if...

        3. 17.(1) Arrangements of the kind mentioned in paragraphs 15(b) and...

        4. 18.A laboratory to which a sample is submitted under paragraph...

        5. 19.A laboratory that has analysed or examined a sample submitted...

        6. 20.A person to whom a part of the sample is...

      5. Provisions as to evidence

        1. 21.(1) In proceedings for an offence under these Regulations, a...

        2. 22.In proceedings for an offence under these Regulations, a document...

        3. 23.(1) If, in proceedings before a magistrates' court for an...

      6. Analysis under direction of court

        1. 24.(1) This paragraph applies where proceedings for an offence under...

        2. 25.The costs of analysis or examination under paragraph 24 are...

      7. Proof by written statement

        1. 26.(1) In relation to England and Wales section 9 of...

      8. Payment for sample taken under compulsory powers

        1. 27.(1) Where a sampling officer takes a sample in the...

    40. SCHEDULE 32

      Transitional provisions and savings

      1. Continuity of the law

        1. 1.(1) This paragraph applies where any provision of these Regulations...

      2. Product licences

        1. 2.(1) This paragraph applies to a marketing authorisation that—

      3. Product licences of right

        1. 3.(1) This paragraph applies to a product licence of right....

      4. Classification of UK marketing authorisation and certificate of registration

        1. 4.(1) Sub-paragraph (3) applies to a UK marketing authorisation granted...

      5. Advanced therapy medicinal products

        1. 5.No provision of these Regulations that applies only to advanced...

      6. Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010 (S.I. 2010/1882)

        1. 6.Regulation 9 (amendment of the Medicines for Human Use (Clinical...

      7. Section 60 of the Medicines Act 1968 etc

        1. 7.(1) Section 60 of the Medicines Act 1968 (“the Act”)...

    41. SCHEDULE 33

      Transitional arrangements: pharmacovigilance

      1. 1.Pharmacovigilance system master file

      2. 2.Regulation 210(3)(b) (offences relating to pharmacovigilance obligations under Regulation (...

      3. 3.Post-authorisation safety studies

      4. 4.Regulation 210(3)(g) (offences relating to pharmacovigilance obligations under Regulation (EC)...

      5. 5.Reporting obligations

      6. 6.The references to “the Eudravigilance database” in regulation 188(1)(a) and...

      7. 7.The licensing authority must ensure that all reports and updated...

      8. 8.Regulations 186(1)(e) (reporting obligations on licensing authority in relation to...

      9. 9.Periodic safety update reports

      10. 10.The reference to “the EMA” in regulations 191(1) (obligation on...

    42. SCHEDULE 33A

      Transitional provision in relation to EU Exit

      1. PART 1 Interpretation

        1. 1.In this Schedule— “ the COMP ” means the Committee...

      2. PART 2 Manufacturing, wholesale dealing and brokering

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

        2. 3.Approved country for import list on IP completion day (regulation 18A)

        3. 4.Qualified persons and approved country for batch testing list on IP completion day (Schedule 7)

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

      3. PART 3 Transitional provision in respect of conversion of EU marketing authorisations in force immediately before IP completion day

        1. 6.Conversion of EU marketing authorisations in force before IP completion day

        2. 7.Classification of converted EU marketing authorisations

        3. 8.Obligations of licensing authority in connection with converted EU marketing authorisations

        4. 9.Obligations of holders of converted EU marketing authorisations

        5. 10.Powers of licensing authority in connection with provision of information

        6. 11.Variations of converted EU marketing authorisations notified or applied for before IP completion day

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

        8. 13.Variations of converted EU marketing authorisations sought in advance of the data submission date

        9. 14.Applications for renewals of converted EU marketing authorisations made before IP completion day

        10. 15.Applications for renewals of conditional marketing authorisations made before IP completion day

        11. 16.Applications for renewals of converted EU marketing authorisations made after IP completion day

        12. 17.Applications for renewals of conditional marketing authorisations made after IP completion day

        13. 18.Renewals of converted EU marketing authorisations sought in advance of the data submission date

        14. 19.Article 61(3) notifications made before IP completion day in relation to converted EU marketing authorisations

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

        16. 21.Article 61(3) notifications sought in advance of the data submission date

        17. 22.Place of establishment for converted EU marketing authorisation holder established in EEA state before IP completion day

        18. 23.Temporary exemption as to packaging requirements for converted EU marketing authorisations

        19. 24.Referrals made under Article 20 of Regulation (EC) No 726/2004 that have not concluded or been implemented before IP completion day

        20. 25.Enforcement

      4. PART 4 Transitional provision in respect of UK marketing authorisations, parallel import licences and parallel distribution notices

        1. 26ZA. Status of certain UK marketing authorisations granted before IP completion day

        2. 26.Place of establishment for UK marketing authorisation holder or parallel import licence holder established in an EEA State before IP completion day

        3. 27.Temporary exemption as to packaging requirements: change of place of establishment

        4. 27A. Status of parallel import licences granted before IP completion day

        5. 28.Conversion of parallel distribution notices in to parallel import licences

        6. 29.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)

        7. 29A. 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)

        8. 30.Existing data and marketing exclusivity and global marketing authorisations

        9. 31.Applications for EU marketing authorisations made before IP completion day

        10. 32.Place of establishment for UK marketing authorisation holder established in EEA state before IP completion day (pre-exit EU marketing authorisation applications)

        11. 33.Packaging in relation to UK marketing authorisations granted in response to application for EU marketing authorisation made before IP completion day

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

        13. 35.Transitional provision in respect of Plasma Master Files

        14. 36.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

        15. 37.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

      5. PART 5 Transitional provision in relation to variations of marketing authorisations other than converted EU marketing authorisations

        1. 38.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)

        2. 39.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)

        3. 40.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)

      6. PART 6 Transitional provision in relation to the Paediatric Regulation

        1. 41.Transitional provision in relation to applications made to EMA before IP completion day under the Paediatric Regulation

        2. 41A. Transitional provision in relation to global marketing authorisations under the 2001 Directive

      7. PART 8 Transitional provision in respect of homoeopathic medicinal products

        1. 43.List of countries for the purposes of the definition of “homoeopathic medicinal product” on IP completion day

        2. 44.Place of establishment for holders of certificates of registration established in EEA before IP completion day

        3. 45.Temporary exemption as to packaging requirements: change of place of establishment

        4. 46.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

        5. 47.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

        6. 48.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

      8. PART 9 Transitional provision in respect of traditional herbal registrations

        1. 49.Place of establishment for holders of traditional herbal registrations established in EEA before IP completion day

        2. 50.Temporary exemption as to packaging requirements: change of place of establishment

        3. 51.List of approved countries for traditional use of a herbal medicinal product on IP completion day

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

        5. 53.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

        6. 54.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

        7. 55.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

      9. PART 10 Transitional provision in respect of pharmacovigilance

        1. 58.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

        2. 59.Matters on-going at IP completion day in respect of periodic safety update reports

        3. 60.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)

        4. 61.Matters on-going at IP completion day in respect of the follow up of final study reports

      10. PART 11 Transitional provision in respect of Part 12

        1. 62.Approved country health professional list on IP completion day (regulation 214(6A))

      11. PART 12 General provision in relation to transitional provisions

        1. 63.Licensing authority power to require information

    43. SCHEDULE 34

      Amendments to existing law

      1. PART 1 The Medicines Acts 1968 and 1971

        1. 1.The Medicines Act 1968 is amended as follows.

        2. 2.For the text of section 1 (Ministers responsible for the...

        3. 3.In section 10 (exemptions for pharmacists)— (a) in subsection (1)...

        4. 4.In section 15 (provision for extending or modifying exemptions)—

        5. 5.In section 58 (medicinal products on prescription only)—

        6. 6.In section 58A(1) (requirement to specify certain products as prescription-only...

        7. 7.In section 62 (prohibition of sale or supply, or importation,...

        8. 8.In section 64(5) (protection for purchasers of medicinal products) for...

        9. 9.(1) Section 67 (offences under Part III) is amended as...

        10. 10.In section 72 (representative of pharmacist in case of death...

        11. 11.In section 82(4) (pharmacies: procedure relating to disqualification) for “Pharmaceutical...

        12. 12.In section 87 (requirements as to containers)—

        13. 13.In section 88(1) (distinctive colours, shapes and markings of medicinal...

        14. 14.In section 91 (offences under Part V, and supplementary provisions)—...

        15. 15.In section 104 (application of Act to certain articles and...

        16. 16.In section 105 (application of Act to certain other substances...

        17. 17.In section 107 (validity of decisions and proceedings relating thereto)—...

        18. 18.(1) Section 108 (enforcement in England and Wales) is amended...

        19. 19.In section 109 (enforcement in Scotland)— (a) in subsection (2)—...

        20. 20.In section 110 (enforcement in Northern Ireland)—

        21. 21.In section 111 (rights of entry)— (a) in subsection (1)...

        22. 22.In section 113(1) (application of sampling procedure to substance or...

        23. 23.In section 114(1) (supplementary provisions as to rights of entry...

        24. 24.In section 121(4) (contravention due to default of other person),...

        25. 25.In section 122(2) (warranty as defence), for the words “section...

        26. 26.In section 123(1)(b) (offences in relation to warranties and certificates...

        27. 27.In section 125 (prosecutions)— (a) in subsection (4)—

        28. 28.In section 126 (presumptions)— (a) in subsection (1), omit paragraph...

        29. 29.In section 128 (financial provisions)— (a) in subsection (1), for...

        30. 30.In section 129 (orders and regulations)— (a) in subsection (2),...

        31. 31.In section 130 (meaning of medicinal product and related expressions)—...

        32. 32.In section 131(5) (meaning of “wholesale dealing”, “retail sale” and...

        33. 33.In section 132 (general interpretation provisions)— (a) for subsection (1)...

        34. 34.In Schedule 3 (sampling)— (a) omit paragraphs 5 to 7;...

        35. 35.In Schedule 4 (provisions relating to Northern Ireland)—

        36. Medicines Act 1971

          1. 36.(1) The Medicines Act 1971 shall have effect as follows....

      2. PART 2 Other primary legislation

        1. Trade Descriptions Act 1968

          1. 37.In section 2(5)(b) (trade descriptions) of the Trade Descriptions Act...

        2. House of Commons Disqualification Act 1975

          1. 38.In Part II (bodies of which all members are disqualified)...

        3. Northern Ireland Assembly Disqualification Act 1975

          1. 39.In Part II (bodies of which all members are disqualified)...

        4. Consumer Protection Act 1987

          1. 40.Section 19(1) (interpretation of Part II) of the Consumer Protection...

        5. Environmental Protection Act 1990

          1. 41.In section 142(7) (powers to obtain information about potentially hazardous...

        6. Value Added Tax Act 1994

          1. 42.In Part II of Schedule 8 (zero-rating) to the Value...

        7. Health Act 1999

          1. 43.In section 60(2A)(c) (regulation of health care and associated professions)...

        8. Communications Act 2003

          1. 44.In section 368R(1) (interpretation of Part 4A) of the Communications...

        9. Christmas Day and New Year's Day Trading (Scotland) Act 2007

          1. 45.In section 7 (interpretation) of the Christmas Day and New...

      3. PART 3 Northern Ireland Orders in Council

        1. Health and Personal Social Services (Northern Ireland) Order 1972

          1. 46.The Health and Personal Social Services (Northern Ireland) Order 1972...

        2. Pharmacy (Northern Ireland) Order 1976

          1. 47.In article 2(2) of the Pharmacy (Northern Ireland) Order 1976...

        3. Poisons (Northern Ireland) Order 1976

          1. 48.In article 2(2) of the Pharmacy (Northern Ireland) Order 1976...

        4. Diseases of Animals (Northern Ireland) Order 1981

          1. 49.In article 38 of the Diseases of Animals (Northern Ireland)...

        5. Waste and Contaminated Land (Northern Ireland) Order 1997

          1. 50.In article 33(6) of the Waste and Contaminated Land (Northern...

        6. Shops (Sunday Trading &c.) (Northern Ireland) Order 1997

          1. 51.In article 4(3) of the Shops (Sunday Trading &c.) (Northern...

      4. PART 4 The Medicines for Human Use (Clinical Trials) Regulations 2004

        1. 52.The Medicines for Human Use (Clinical Trials) Regulations 2004 are...

        2. 53.In regulation 2(1) (interpretation)— (a) before the definition “the Act”...

        3. 54.In regulation 4(3) (responsibility for functions under the Directive) for...

        4. 55.In regulation 19(10) (authorisation procedure for clinical trials involving medicinal...

        5. 56.In regulation 46(2)(c) (labelling) for words from “Schedule 5” to...

        6. 57.In regulation 47 (application of enforcement provisions of the Act)—...

        7. 58.In regulation 48(5) (infringement notices) for “sections 108 to 110...

        8. 59.In regulation 49(5) (offences) for “the Act” substitute “ the...

        9. 60.In regulation 53(3) (construction of references to specified publications) for...

        10. 61.In paragraph 4(2) of Schedule 5 (procedural provisions relating to...

        11. 62.In Schedule 7 (standard provisions for manufacturing authorisations)—

        12. 63.In paragraph 5(2) of Schedule 8 (procedural provisions relating to...

        13. 64.For Schedule 9 substitute the following Schedule— SCHEDULE 9 MODIFICATIONS OF...

      5. PART 5 Other United Kingdom, Scotland and Wales Secondary legislation

        1. Medicines (Administration of Radioactive Substances) Regulations 1978

          1. 65.In regulation 8(1) of the Medicines (Administration of Radioactive Substances)...

        2. Importation of Animal Products and Poultry Products Order 1980

          1. 66.In the Schedule to the Importation of Animal Products and...

        3. Medicines Act (Hearings by Persons Appointed) (Scotland) Rules 1986

          1. 67.In rule 2 of The Medicines Act (Hearings by Persons...

        4. Medicines Act (Hearings by Persons Appointed) Rules 1986

          1. 68.In rule 2 of The Medicines Act (Hearings by Persons...

        5. Medicines (Fixing of Fees Relating to Medicinal Products for Human Use) Order 1989

          1. 69.(1) The Medicines (Fixing of Fees Relating to Medicinal Products...

        6. Medical Devices (Consultation Requirements) (Fees) Regulations 1995

          1. 70.In regulation 1(2) of the Medical Devices (Consultation Requirements) (Fees)...

        7. Prescription Only Medicines (Human Use) Order 1997

          1. 71.(1) The Prescription Only Medicines (Human Use) Order 1997 is...

        8. General Optical Council (Rules relating to Injury or Disease of the Eye) Order of Council 1999

          1. 72.In rule 7B(b) of the Schedule to the General Optical...

        9. National Health Service (Charges for Drugs and Appliances) Regulations 2000

          1. 73.The National Health Service (Charges for Drugs and Appliances) Regulations...

        10. Biocidal Products Regulations 2001

          1. 74.In Schedule 2 to the Biocidal Products Regulations 2001 —...

        11. Medicines (Aristolochia and Mu Tong etc) (Prohibition Order) 2001

          1. 75.In article 4(4) of the Medicines (Aristolochia and Mu Tong...

        12. Misuse of Drugs Regulations 2001

          1. 76.In regulation 2(1) of the Misuse of Drugs Regulations 2001...

        13. Medicines for Human Use (Kava-kava) (Prohibition Order) 2002

          1. 77.In paragraph (d) of article 3 of the Medicines for...

        14. Medicines and Healthcare Products Regulatory Agency Trading Fund Order 2003

          1. 78.In article 1(3) of the Medicines and Healthcare Products Regulatory...

        15. Enterprise Act 2002 (Part 8 Community Infringements Specified UK Laws) Order 2003

          1. 79.In the column “specified UK laws” of the Schedule to...

        16. Enterprise Act 2002 (Part 8 Notice to OFT of Intended Prosecution Specified Enactments, Revocation and Transitional Provision) Order 2003

          1. 80.In the Schedule to the Enterprise Act 2002 (Part 8...

        17. Health Professions (Parts of and Entries in the Register) Order of Council 2003

          1. 81.In article 6 of the Health Professions (Parts of and...

        18. Unlicensed Medicinal Products for Human Use (Transmissible Spongiform Encephalopathies) (Safety) Regulations 2003

          1. 82.(1) The Unlicensed Medicinal Products for Human Use (Transmissible Spongiform...

        19. National Health Service (General Medical Services Contracts) (Scotland) Regulations 2004

          1. 83.(1) The National Health Service (General Medical Services Contracts) (Scotland)...

        20. National Health Service (Primary Medical Services Section 17C Agreements) (Scotland) Regulations 2004

          1. 84.(1) The National Health Service (Primary Medical Services Section 17C...

        21. National Health Service (General Medical Services Contracts) Regulations 2004

          1. 85.(1) The National Health Service (General Medical Services Contracts) Regulations...

        22. National Health Service (General Medical Services Contracts) (Wales) Regulations 2004

          1. 86.(1) The National Health Service (General Medical Services Contracts) (Wales)...

        23. National Health Service (Personal Medical Services Agreements) Regulations 2004

          1. 87.(1) The National Health Service (Personal Medical Services Agreements) Regulations...

        24. National Health Service (General Medical Services Contracts) (Prescription of Drugs Etc.) (Wales) Regulations 2004

          1. 88.In Schedule 2 to the National Health Service (General Medical...

        25. Contracting Out (Functions relating to Broadcast Advertising) and Specification of Relevant Functions Order 2004

          1. 89.(1) The Contracting Out (Functions relating to Broadcast Advertising) and...

        26. General Optical Council (Registration Rules) Order of Council 2005

          1. 90.In the Table in rule 10 of the Schedule to...

        27. National Health Service (Free Prescriptions and Charges for Drugs and Appliances) (Wales) Regulations 2007

          1. 91.(1) The National Health Service (Free Prescriptions and Charges for...

        28. Human Tissue (Quality and Safety for Human Application) Regulations 2007

          1. 92.In regulation 2(3) of the Human Tissue (Quality and Safety...

        29. Legislative and Regulatory Reform (Regulatory Functions) Order 2007

          1. 93.(1) The Schedule to the Legislative and Regulatory Reform (Regulatory...

        30. Medicines for Human Use (Prohibition) (Senecio and Miscellaneous Amendments) Order 2008

          1. 94.In paragraph (d) of article 3 of the Medicines for...

        31. Specified Animal Pathogens Order 2008

          1. 95.In article 5(2) of the Specified Animal Pathogens Order 2008...

        32. Specified Animal Pathogens (Wales) Order 2008

          1. 96.In article 5(2) of the Specified Animal Pathogens (Wales) Order...

        33. Health Service Branded Medicines (Control of Prices and Supply of Information) (No 2) Regulations 2008

          1. 97.In regulation 1(2) of the Health Service Branded Medicines (Control...

        34. Specified Animal Pathogens (Scotland) Order 2009

          1. 98.In article 5(2) of the Specified Animal Pathogens (Scotland) Order...

        35. National Health Service (Pharmaceutical Services) (Scotland) Regulations 2009

          1. 99.(1) The National Health Service (Pharmaceutical Services) (Scotland) Regulations 2009...

        36. Co-ordination of Regulatory Enforcement (Regulatory Functions in Scotland and Northern Ireland) Order 2009

          1. 100.(1) The Co-ordination of Regulatory Enforcement (Regulatory Functions in Scotland...

        37. Single Use Carrier Bags Charge (Wales) Regulations 2010

          1. 101.In Schedule 1(3) to the Single Use Carrier Bags Charge...

      6. PART 6 Northern Ireland statutory rules

        1. Control of Pesticides Regulations (Northern Ireland) 1987

          1. 102.For regulation 3(2)(b)(i) of the Control of Pesticides Regulations (Northern...

        2. Prison and Young Offenders Centre (Amendment) Rules (Northern Ireland) 1995

          1. 103.In rule 4 of the Prison and Young Offenders Centre...

        3. Diseases of Animals (Importation of Bird Products) Order (Northern Ireland) 1996

          1. 104.In the Schedule to the Diseases of Animals (Importation of...

        4. Pharmaceutical Services Regulations (Northern Ireland) 1997

          1. 105.In Part 2 of Schedule 2 to the Pharmaceutical Services...

        5. Industrial Pollution Control (Prescribed Processes and Substances) Regulations (Northern Ireland) 1998

          1. 106.In Schedule 1, Chapter 4, Section 4.8, Part C of...

        6. Products of Animal Origin (Import and Export) Regulations (Northern Ireland) 1998

          1. 107.The Products of Animal Origin (Import and Export) Regulations (Northern...

        7. Importation of Animal Pathogens Order (Northern Ireland) 1999

          1. 108.In article 5(a) of the Importation of Animal Pathogens Order...

        8. Biocidal Products Regulations (Northern Ireland) 2001

          1. 109.In Schedule 2 to the Biocidal Products Regulations (Northern Ireland)...

        9. Misuse of Drugs Regulations (Northern Ireland) 2002

          1. 110.(1) The Misuse of Drugs Regulations (Northern Ireland) 2002 are...

        10. Control of Substances Hazardous to Health Regulations (Northern Ireland) 2003

          1. 111.In regulation 5(2)(c) of the Control of Substances Hazardous to...

        11. Waste Management Licensing Regulations (Northern Ireland) 2003

          1. 112.In paragraph 2 of Schedule 1 to the Waste Management...

        12. Health and Personal Social Services (General Medical Services Contracts) Regulations (Northern Ireland) 2004

          1. 113.(1) The Health and Personal Social Services (General Medical Services...

        13. Nursing Homes Regulations (Northern Ireland) 2005

          1. 114.In regulation 13(6)(b) of the Nursing Homes Regulations (Northern Ireland)...

        14. Residential Care Homes Regulations (Northern Ireland) 2005

          1. 115.In regulation 13(6)(b) of the Nursing Homes Regulations (Northern Ireland)...

        15. Children's Homes Regulations (Northern Ireland) 2005

          1. 116.In regulation 20(4)(b) of the Children's Homes Regulations (Northern Ireland)...

        16. Healthy Start Scheme and Day Care Food Scheme Regulations (Northern Ireland) 2006

          1. 117.In regulation 3(1) of the Healthy Start Scheme and Day...

        17. Avian Influenza and Influenza of Avian Origin in Mammals Regulations (Northern Ireland) 2007

          1. 118.In regulation 71(3)(a) of the Avian Influenza and Influenza of...

        18. Day Care Setting Regulations (Northern Ireland) 2007

          1. 119.In regulation 13(6)(b) of the Day Care Setting Regulations (Northern...

        19. Residential Family Centres Regulations (Northern Ireland) 2007

          1. 120.In regulation 13(4)(b) of the Residential Family Centres Regulations (Northern...

        20. Natural Mineral Water, Spring Water and Bottled Drinking Water Regulations (Northern Ireland) 2007

          1. 121.In regulation 3(1)(a) of the Natural Mineral Water, Spring Water...

        21. Specified Animal Pathogens Order (Northern Ireland) 2008

          1. 122.In article 5(2)(b) of the Specified Animal Pathogens Order (Northern...

        22. Controlled Drugs (Supervision of Management and Use) Regulations (Northern Ireland) 2009

          1. 123.In regulation 2(2) of the Controlled Drugs (Supervision of Management...

        23. Private Water Supplies Regulations (Northern Ireland) 2009

          1. 124.In regulation 4(b) of the Private Water Supplies Regulations (Northern...

    44. SCHEDULE 35

      Repeals and revocations

  22. Explanatory Note

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