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Statutory Instruments

2008 No. 552

Medicines

Fees And Charges

Consumer Protection

The Medicines (Products for Human Use-Fees) Regulations 2008

Made

28th February 2008

Laid before Parliament

7th March 2008

Coming into force

1st April 2008

Contents

Go to Preamble

  1. PART 1

    General

    1. 1. Citation and commencement

    2. 2. Interpretation

  2. PART 2

    Capital Fees for Pre-Application Meetings

    1. 3. Interpretation of Part 2

    2. 4. Fee for scientific advice: application for variation to EC fee marketing authorisation

    3. 5. Fee for scientific advice: classification of a medicinal product

    4. 6. Fee for advertising advice

    5. 7. Fee for pharmacovigilance advice

    6. 8. Fee for advice on labelling or leaflets

    7. 9. Fee for regulatory advice

    8. 10. Fee for advice for other purposes

    9. 11. Time for payment of fees under regulations 4 to 10

  3. PART 3

    Capital Fees for Applications for Authorizations, Registrations, Licences, Certificates or Authorisations and for Associated Inspections

    1. 12. Fees for applications for authorizations, licences or certificates, etc

    2. 13. Fee for applications for copy certificates of good manufacturing practice

    3. 14. Fees for applications for certificates and copy certificates by exporters of medicinal products

  4. PART 4

    Capital Fees for Assistance in Obtaining Marketing Authorizations in Other EEA States

    1. 15. Meaning of “set of applications”

    2. 16. Fees for applications for regulatory assistance under the mutual recognition procedure

    3. 17. Time for payment of fees under regulation 16

  5. PART 5

    Capital Fees for Applications for Variations of Authorizations, Registrations, Licences and Certificates and for Associated Inspections

    1. 18. Fees for variations of authorizations, registrations, licences and authorisations

    2. 19. Fees for amendments to clinical trial authorisations

    3. 20. Applications for multiple variations

  6. PART 6

    Capital Fees for Assessment of Labels and Leaflets

    1. 21. Meaning of “set of proposed changes”

    2. 22. Fees for assessment of a set of proposed changes to labels and leaflets

    3. 23. Time for payment of fees under regulation 22

  7. PART 7

    Capital Fees for Applications for Renewals of Certain Manufacturer’s Licences and for Associated Inspections

    1. 24. Fees for renewals of certain manufacturer’s licences

    2. 25. Fees for renewals in terms which are not identical to the existing authorization, licence or certificate

  8. PART 8

    Capital Fees for Regulatory Assistance Given by the United Kingdom Acting as Reference Member State Relating to the Assessment of Applications for the Renewal of Specified Marketing Authorizations

    1. 26. Fees for regulatory assistance for certain marketing authorisations

  9. PART 9

    Capital Fees for Inspections

    1. 27. Fees for inspections

    2. 28. Payer of inspection fee (contract laboratories and API manufacturing sites)

    3. 29. Inspections in connection with multiple applications.

    4. 30. Fees for inspections relating to good clinical practice in clinical trials

  10. PART 10

    Periodic Fees for Marketing Authorizations and Licences

    1. 31. Periodic fees

    2. 32. Periodic fees for clinical trial authorisations

  11. PART 11

    Capital Fees For Application For Membership of Good Clinical Practice Accreditation Scheme and for Certificate of Membership

    1. 33. Meaning of “good clinical practice accreditation” scheme

    2. 34. Fees for applications for membership and certificate

  12. PART 12

    Capital Fees for Persons Appointed Hearing

    1. 35. Fees for persons appointed hearing

    2. 36. Time for payment under regulation 35

  13. PART 13

    Administration

    1. 37. Payment of fees to Ministers

    2. 38. Time for payment of capital fees in connection with applications or inspections

    3. 39. Time for payment of capital fees – applications made by small companies

    4. 40. Time for payment of periodic fees

    5. 41. Penalty fees for late payment of periodic fees

    6. 42. Daily penalty fees for late payment of periodic fees

    7. 43. Refund or waiver of fees under regulation 41(1) or 42

    8. 44. Adjustment, waiver, reduction or refund of fees

    9. 45. Suspension of licences and certificates

    10. 46. Civil proceedings to recover unpaid fees

  14. PART 14

    1. 47. Amendment of the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994

  15. PART 15

    Revocation and Savings

    1. 48. Revocation and savings

    2. 49. Transitional provisions

    1. SCHEDULE 1

      CAPITAL FEES FOR APPLICATIONS FOR, AND VARIATIONS TO, MARKETING AUTHORIZATIONS, LICENCES AND CERTIFICATES

      1. PART 1

        Interpretation

      2. PART 2

        Capital Fees for Applications for Authorizations, Licences and Certificates

      3. PART 3

        Capital Fees for Assistance in Obtaining Marketing Authorizations in Other EEA States

      4. PART 4

        Capital Fees for Applications for Variations of Authorizations, Licences and Registrations

      5. PART 5

        Capital Fees for Assessment of Labels and Leaflets

      6. PART 6

        Capital Fees for Regulatory Assistance Given by the United Kingdom Acting as Reference Member State Relating to the Assessment of Applications for the Renewal of Specified Marketing Authorizations

    2. SCHEDULE 2

      FEES FOR INSPECTIONS

    3. SCHEDULE 3

      PERIODIC FEES FOR LICENCES

      1. PART 1

        Interpretation

      2. PART 2

        Calculation of Turnover

      3. PART 3

        Periodic Fees for Marketing Authorizations and Licences

      4. PART 4

        Types of Marketing Authorization for which only One Periodic Fee is Payable

    4. SCHEDULE 4

      Time for Payment of Capital Fees

    5. SCHEDULE 5

      WAIVER, REDUCTION OR REFUND OF CAPITAL FEES

    6. SCHEDULE 6

      ADJUSTMENT, REDUCTION OR REFUND OF PERIODIC FEES

    7. SCHEDULE 7

      REVOCATION SCHEDULE

Go to Explanatory Note

The Secretary of State for Health, the Minister for Health, Social Services and Public Safety and the Minister for Agriculture and Rural Development, acting jointly, make the following Regulations in exercise of the powers conferred on them by section 1(1) and (2) of the Medicines Act 1971(1) or, in the case of the Ministers, the powers conferred by those provisions and now vested in them(2).

In so far as these Regulations are not made under section 1(1) and (2) of the Medicines Act 1971, the Secretary of State makes these Regulations in exercise of the powers conferred on him by section 2(2) of the European Communities Act 1972(3) and section 56(1) and (2) of the Finance Act 1973(4). The Secretary of State has been designated for the purposes of section 2(2) of the European Communities Act 1972 in relation to medicinal products(5).

The Treasury has consented to the making of these Regulations as required by section 1(1) of the Medicines Act 1971 and section 56(1) of the Finance Act 1973.

In accordance with section 129(6) of the Medicines Act 1968(6), the Secretary of State for Health, the Department of Health, Social Services and Public Safety Development have consulted with such organisations as appear to them to be representative of interests likely to be substantially affected by these Regulations.

(1)

1971 c.69; as amended by section 21 of the Health and Medicines Act 1988 (c.49). By virtue of section 1(3) of the 1971 Act, expressions used in that section have the same meaning as in the Medicines Act 1968 (c.67); see therefore section 1(1) of the 1968 Act, as amended by article 2(2) of, and Schedule 1 to, S.I. 1969/388, by article 5 of, and the Schedule to, S.I. 1999/3142, by article 5(1) of, and paragraph 15 of Schedule 1 to, S.I. 2002/794 and by regulation 44 of, and Schedule 8 to, S.I. 2006/2407, which contains a definition of the expression “the Ministers”, which is relevant to the powers being exercised in the making of these Regulations. See also regulation 9(12) of the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 (S.I. 1994/3144), by virtue of which the references in section 1(1) and (2)(b) of the 1971 Act to an application for a licence or for the variation or renewal of such a licence under Part II of the 1968 Act include reference to an application for a marketing authorization under the 1994 Regulations or for the variation or renewal of such an authorization. Back [1]

(2)

In the case of the Secretary of State, by virtue of article 2(1) of S.I. 1999/3142 and article 3(7) of S.I. 2002/794. In the case of the Minister for Health, Social Services and Public Safety and the Minister for Agriculture and Rural Development, by virtue of section 95(5) of, and paragraph 10 of Schedule 12 to, the Northern Ireland Act 1998 (c.47); the Departments for which the Ministers are responsible were renamed by virtue of Article 3(4) and (6) of S.I. 1999/283 (N.I. 1). Back [2]

(4)

1973 c.51. Back [4]

(5)

S.I.1972/181. Back [5]

(6)

C.67; section 129(6) was extended by section 1(3)(b) of the Medicines Act 1971. Back [6]

Amended by correction slip on 01 March 2008

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