The Branded Health Service Medicines (Costs) Regulations 2018

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1. Introductory Text

2. 1. Citation, commencement and interpretation

3. 2. Application

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   PART 1 PAYMENT SCHEME

   1. 3. Payment scheme

   2. 3A. Older presentation additional payments

   3. 3B. Meaning of newer presentation and older presentation

   4. 3C. Reference prices for older presentations

   5. 3D. Determination of reference prices

   6. 4. Direction to make a payment

   7. 5. Interest payable on late payment

   8. 6. Penalties

   9. 7. Demands and appeals

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   PART 2 MAXIMUM PRICES

   1. 8. Maximum price

   2. 9. New presentation

   3. 10. Temporary exemptions

   4. 11. Increases

   5. 12. Decreases

   6. 13. Former voluntary scheme members

   7. 14. Recoverable sum

   8. 15. Interest payable on late payment of the recoverable sum

   9. 16. Penalties

   10. 17. Demands and appeals

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   PART 3 INFORMATION REQUIREMENTS

   1. 18. Provision of information for payment scheme

   2. 19. New manufacturer or supplier

   3. 20. Small manufacturer or supplier

   4. 21. Sales report

   5. 22. Presentation report

   6. 23. Audited information

   7. 24. Written declaration of approval

   8. 25. Review

   9. 26. Penalties, demands and appeals

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   PART 4 GENERAL PROVISIONS

   1. 27. Appeals

   2. 28. Revocation, saving and transitional provisions

   3. 29. Annual review

8. Signature

9. SCHEDULES

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      SCHEDULE 1

      General provisions for payment scheme

      1. 1. Payment scheme requirements

      2. 1A. Any payment required to be made under regulation 3(1AA) by...

      3. 2. Information requirements

      4. 3. Rules

      5. 4. Where the requirement to make a payment set out in...

      6. 5. Where the requirement to make a payment set out in...

      7. 6. Where a manufacturer or supplier changes the length of their...

      8. 7. A manufacturer's or supplier's “previous accounting reference period” means the...

      9. 8. A manufacturer or supplier whose financial year does not end...

      10. 9. A manufacturer or supplier must provide two or more separate...

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      SCHEDULE 2

      Small manufacturer or supplier

      1. 1. Determination of small manufacturer or supplier

      2. 2. The manufacturer or supplier referred to in paragraph 1(a) is...

      3. 3. The manufacturer or supplier referred to in paragraph 1(b) is...

      4. 4. Information requirements

      5. 5. A manufacturer or supplier referred to in paragraph 3 must...

      6. 6. Rules

      7. 7. The end date of the final period in the manufacturer's...

      8. 8. Where a manufacturer or supplier changes the length of their...

      9. 9. A manufacturer's or supplier's “previous accounting reference period” means the...

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      SCHEDULE 3

      New manufacturer or supplier

      1. 1. Information requirements

      2. 2. Where the new manufacturer or supplier is not a small...

      3. 3. Rules

      4. 4. The end date of the final period in a manufacturer's...

      5. 5. Where the requirement to make a payment set out in...

      6. 6. Where the requirement to make a payment set out in...

      7. 7. Where a manufacturer or supplier changes the length of their...

      8. 8. A manufacturer's or supplier's “previous accounting reference period” means the...

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      SCHEDULE 4

      Recoverable Sums

      1. 1. For the purposes of regulation 14, the recoverable sum will...

      2. 2. In respect of a contravention described in column (1) of...

      3. 3. For the purposes of this Schedule— (a) “second contravention” occurs...

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      SCHEDULE 5

      Penalties

      1. 1. Subject to paragraph 2, the daily penalty payable by a...

      2. 2. Where the Secretary of State is unable to reasonably determine...

      3. 3. Subject to paragraph 4, for the purposes of table 2,...

      4. 4. For the purposes of table 2, the Total United Kingdom...

10. Explanatory Note