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The Health Service Products (Provision and Disclosure of Information) Regulations 2018

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  1. Introductory Text

  2. PART 1 Introductory

    1. 1.Citation and commencement

    2. 2.Interpretation: general

    3. 3.Application

    4. 4.Exception: products not known to be health service products

    5. 5.Information required to be provided via an NHS England online gateway

  3. PART 2 Quarterly information about unbranded generic health service medicines

    1. 6.Meaning of “unbranded generic health service medicine” and listing of a presentation of unbranded generic health service medicine

    2. 7.Information to be recorded and kept about supply of unbranded generic health service medicines: manufacturers and importers

    3. 8.Information to be recorded and kept about supply of unbranded generic health service medicines: medicines wholesalers

    4. 9.Requirement to provide information about supply of unbranded generic health service medicines

  4. PART 3 Quarterly information about special health service medicines

    1. 10.Meaning of “special health service medicine”, “imported special health service medicine”, “made special health service medicine” and listing of a presentation of special health service medicine in a Drug Tariff

    2. 11.Information to be recorded about supply of made special health service medicines: manufacturers

    3. 12.Information to be recorded about supply of made special health service medicines: medicines wholesalers

    4. 13.Information to be recorded and kept about supply of imported special health service medicines: medicines wholesalers and importers

    5. 14.Requirement to provide information about the supply of special health service medicines

  5. PART 4 General information about supply of UK health service products

    1. 15.Categories of purchaser

    2. 16.Information to be recorded and kept about supply of imported special health service medicines: medicines wholesalers and importers

    3. 17.Information to be recorded and kept about supply of health service medicines other than imported special health service medicines: medicines wholesalers

    4. 18.Information to be recorded and kept about supply of health service medicines other than imported special health service medicines: other UK producers

    5. 19.Information to be recorded and kept about supply of health service medicines to patients otherwise than by sale

    6. 20.Information to be recorded and kept about supply of health service appliances: manufacturers and importers

    7. 21.Information to be recorded and kept about supply of listed health service appliances: medical supplies wholesalers

    8. 22.Information to be recorded and kept about supply of appliances, food and dermatological products to patients otherwise than by sale

    9. 23.Provision of information recorded and kept under this Part to the Secretary of State

    10. 24.Provision of information: small producers

  6. PART 5 Information about costs incurred in connection with the manufacturing, distribution or supply of UK health service products

    1. 25.Provision of information about costs incurred in connection with the manufacture or distribution of a particular health service medicine or appliance

    2. 26.Provision of general information about costs incurred in connection with the manufacture or distribution of health service medicines and appliances

  7. PART 6 Information about price and availability of health service medicines

    1. 27.Provision of information about English health service medicines which are not available at the reimbursement price

    2. 28.Provision of information about availability of health service medicines

    3. 29.Requirement to provide information about discontinuation or anticipated supply shortage of certain health service medicines

  8. PART 7 Information about reasonable estimates

    1. 30.Requirement to provide information about reasonable estimates

  9. PART 8 Enforcement and appeals

    1. 31.Compliance procedure

    2. 32.Penalties

    3. 33.Appeals

  10. PART 9 Disclosure of information

    1. 34.Disclosure of information

  11. PART 10 Miscellaneous

    1. 35.Transitional provisions

    2. 36.Annual review

  12. Signature

    1. SCHEDULE 1

      Interpretation: general

      1. 1.Interpretation: general

      2. 2.Meaning of “presentation of health service medicine”

      3. 3.Meaning of “UK primary medical services provider”, “Health Service chemist” and related expressions

      4. 4.Meaning of “net NHS expenditure”, “net NHS wholesale income”, “net purchase amount” and “net sales income”

      5. 5.Meaning of “NHS framework contract”

      6. 6.Interpretation: listing of an appliance in a Drug Tariff

    2. SCHEDULE 2

      Small producers

      1. 1.General

      2. 2.Interpretation of Schedule 2

      3. 3.UK primary medical providers who are small producers

      4. 4.Health Service chemists who are small producers

      5. 5.NHS hospital purchasers who are small producers

      6. 6.Other UK producers who are small producers

    3. SCHEDULE 3

      Calculation of daily penalty

      1. 1.Interpretation of Schedule 3

      2. 2.Daily penalty payable by UK producers who are small producers

      3. 3.Daily penalty payable by UK producers who are not small producers

    4. SCHEDULE 4

      Disclosure of information under section 246B of the 2006 Act: prescribed bodies and prescribed purposes

      1. 1.(1) The bodies specified in column 1 of Table 1,...

      2. 2.(1) The bodies specified in column 1 of Table 2...

    5. SCHEDULE 5

      Information about supply of unbranded generic health service medicines or special health service medicines: transitional provisions

      1. 1.General

      2. 2.Transitional provision: information about supply of unbranded generic health service medicines

      3. 3.Circumstances in which transitional provision in paragraph 2 ceases to apply

      4. 4.Transitional provision: information about supply of special health service medicines

      5. 5.Circumstances in which transitional provision in paragraph 4 ceases to apply

  14. Explanatory Note

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