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The Human Medicines Regulations 2012

Status:

This is the original version (as it was originally made). This item of legislation is currently only available in its original format.

  1. Introductory Text

  2. PART 1

    1. 1.Citation and commencement

    2. 2.Medicinal products

    3. 3.Scope of these Regulations: special provisions

    4. 4.Special provisions for pharmacies etc

    5. 5.Classification of medicinal products

    6. 6.The licensing authority and the Ministers

    7. 7.Advertisements relating to medicinal products

    8. 8.General interpretation

  3. PART 2

    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

    1. Grant etc of licences

      1. 17.Manufacturing of medicinal products

      2. 18.Wholesale dealing in medicinal products

      3. 19.Exemptions from requirement for wholesale dealer’s licence

      4. 20.Mixing of medicines

      5. 21.Application for manufacturer’s or wholesale dealer’s licence

      6. 22.Factors relevant to determination of application for manufacturer’s or wholesale dealer’s licence

      7. 23.Grant or refusal of licence

      8. 24.Standard provisions of licences

      9. 25.Duration of licence

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

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

      12. 28.Suspension of licence in cases of urgency

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

      14. 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

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

      4. 45.Requirement as to responsible persons

  5. PART 4

    1. 46.Requirement for authorisation

    2. 47.Breach of requirement

  6. PART 5

    1. 48.Application of this Part

    2. Application for UK marketing authorisation

      1. 49.Application for grant of UK marketing authorisation

      2. 50.Accompanying material

      3. 51.Applications relating to generic medicinal products

      4. 52.Applications relating to certain medicinal products that do not qualify as generic etc

      5. 53.Applications relating to similar biological medicinal products

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

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

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

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

    3. Consideration of application

      1. 58.Consideration of application

      2. 59.Conditions of UK marketing authorisation: general

      3. 60.Conditions of UK marketing authorisation: exceptional circumstances

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

      5. 62.Classification of UK marketing authorisation

      6. 63.Frequency of periodic safety update reports

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

    4. Validity of UK marketing authorisation

      1. 65.Validity of UK marketing authorisation

      2. 66.Application for renewal of authorisation

      3. 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

      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. Offences relating to specific requirements

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

      2. 80.Urgent safety restrictions

    8. Offences relating to EU marketing authorisations

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

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

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

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

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

      6. 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. General provisions relating to offences

      1. 95.Offences in connection with application

      2. 96.Provision of false or misleading information

      3. 97.Breach of pharmacovigilance condition

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

      5. 99.Penalties

      6. 100.Persons liable

      7. 101.Defences

  7. PART 6

    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

    1. Application of Part

      1. 125.Traditional herbal medicinal products

      2. 126.Addition of vitamins or minerals

    2. 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

    3. Consideration of application

      1. 130.Consideration of application

      2. 131.Classification of traditional herbal registration

    4. 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

    5. 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

    6. 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. 144.Obligation following new herbal monograph

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

      5. 146.Obligation in relation to product information

      6. 147.Record-keeping obligations

      7. 148.Obligation to ensure appropriate and continued supplies

    7. 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

    1. 156.Article 126a authorisations

    2. 157.Requests from other member States

    3. 158.Application of these Regulations

  10. PART 9

    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 etc

    1. Exceptions

      1. 167.Supply to fulfil special patient needs

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

      3. 169.Mixing of general sale medicinal products

      4. 170.Record-keeping requirements

      5. 171.Exempt advanced therapy medicinal products

      6. 172.Parallel import licences

      7. 173.Exemption for certain radiopharmaceuticals

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

    2. Offences

      1. 175.Offences relating to exceptions

      2. 176.Penalties and supplementary provision about offences

  12. PART 11

    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. 187.Recording obligations on holders

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

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

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

      5. 195.Obligation on licensing authority to assess PSURs where EU single assessment procedure does not apply

    7. Urgent action

      1. 196.Urgent action

      2. 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. 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

    10. 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. 211.Persons liable

    11. Transitional arrangements

      1. 212.Transitional arrangements

  13. PART 12

    1. CHAPTER 1

      1. 213.Interpretation

    2. CHAPTER 2

      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. 218.Requirements for prescriptions: EEA health professionals

        6. 219.Electronic prescriptions

      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

      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. 227.Exemption for sale or supply in hospitals

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

        7. 229.Exemption for supply by national health service bodies

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

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

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

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

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

        13. 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. 238.Administration of certain medicines in an emergency

        4. 239.Administration of smallpox vaccine

        5. 240.Radioactive medicinal products

        6. 241.Exemptions in respect of certain herbal remedies

        7. 242.Exemption for medicinal products at high dilution

        8. 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. 248.Exemption for certain collection and delivery arrangements

    4. CHAPTER 4

      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

      2. Disqualification

        1. 256.Disqualification on conviction

  14. PART 13

    1. CHAPTER 1

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

        1. 257.Packaging requirements: general

        2. 258.Packaging requirements: specific provisions

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

        4. 260.Package leaflets

        5. 261.Use of pictures and symbols etc

        6. 262.Labelling requirements for radionuclides

        7. 263.Leaflets relating to radionuclides

        8. 264.Homoeopathic medicines

        9. 265.Additional requirements for traditional herbal medicinal products

        10. 266.Language requirements etc

        11. 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: holder of authorisation etc

        2. 269.Offences relating to packaging and package leaflets: other persons

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

        4. 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

  15. PART 14

    1. CHAPTER 1

      1. 277.Interpretation

      2. 278.Functions of the Ministers

    2. CHAPTER 2

      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. 285.Narcotic and psychotropic substances

        5. 286.Material relating to diagnosis

        6. 287.Material about effects of medicinal product

        7. 288.Material about status of medicinal product

        8. 289.Recommendations by scientists etc

        9. 290.Advertisements directed at children

        10. 291.Form and content of advertisement

        11. 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

      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

  16. PART 15

    1. 317.British Pharmacopoeia and compendia

    2. 318.Lists of names

    3. 319.Other documents

    4. 320.Supplementary provisions

    5. 321.Specified publications

  17. PART 16

    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. 332.Restrictions on disclosure of information

    12. 333.Protection for inspectors

    13. 334.Supplementary provisions and offences

  18. PART 17

    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

    4. Immunity from civil liability

      1. 345.Immunity from civil liability

    5. Review

      1. 346.Review

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

      1. 347.Transitional provisions and savings

      2. 348.Amendments to existing law

      3. 349.Repeals and revocations

  19. Signature

  20. 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 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...

    4. 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...

      2. PART 2 Manufacturer’s licence relating to the import of medicinal products from a state other than an EEA State

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

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

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

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

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

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

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

        8. 22.(1) Where and in so far as the licence relates...

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

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

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

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

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

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

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

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

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

          11. 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...

    5. 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...

    6. 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...

    7. 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.The qualified person is responsible for securing—

        2. 13.(1) This paragraph applies where— (a) a medicinal product which...

        3. 14.(1) This paragraph applies where— (a) medicinal products are imported...

        4. 15.(1) The qualified person is responsible for ensuring, in relation...

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

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

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

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

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

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

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

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

        18. 18.Where an application for authorisation for the medicinal product to...

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

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

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

        22. 22.A copy of any designation of the medicinal product as...

      2. PART 2 Summary of the product characteristics

    9. SCHEDULE 9

      Undertakings by non-EEA 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 marketing authorisation...

      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 marketing authorisation...

    10. 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...

    11. 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 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.This Part is subject to Part 4 of this Schedule....

        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...

      3. PART 3 Referral to the Committee for Herbal Medicinal Products

        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...

      4. 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...

    12. 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 another member State or a...

        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

    13. SCHEDULE 13

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

    14. SCHEDULE 14

      Prescription etc by supplementary prescribers: particulars of clinical management plan

    15. 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...

    16. 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

    17. 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

    18. SCHEDULE 18

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

    19. SCHEDULE 19

      Medicinal products for parenteral administration in an emergency

    20. SCHEDULE 20

      Herbal medicinal products specified for the purposes of regulation 241

      1. PART 1

      2. PART 2

    21. 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

    22. SCHEDULE 22

      Classes of person for the purposes of regulation 249

    23. 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...

    24. 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 marketing...

        16. 16.The number of the marketing authorisation, Article 126a authorisation or...

        17. 17.The manufacturer’s batch number.

        18. 18.In the case of a product that is not 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 marketing authorisation, Article...

        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...

    25. 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...

    26. 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,...

    27. 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 under different names in different...

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

        14. 14.The statement: “Also you can help to make sure that...

        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...

    28. 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”.

    29. 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...

    30. SCHEDULE 30

      Particulars for advertisements to persons qualified to prescribe or supply

      1. 1.The number of the marketing authorisation, certificate of registration, traditional...

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

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

      4. 4.The name of the medicinal product.

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

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

      7. 7.A succinct statement of the entries (if any) in the...

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

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

    31. 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...

    32. 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”)...

    33. SCHEDULE 33

      Transitional arrangements: pharmacovigilance

      1. 1.Pharmacovigilance system master file

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

      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...

    34. 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 2012...

        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— SCHEDULE9 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...

    35. SCHEDULE 35

      Repeals and revocations

  21. Explanatory Note

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