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

1. Introductory Text

2. PART 1 General

   1. 1. Citation and commencement

   2. 2. Interpretation

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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

11. PART 10 Periodic Fees for Marketing Authorizations and Licences

    1. 31. Periodic fees

    2. 32. Periodic fees for clinical trial authorisations

12. 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

13. PART 12 Capital Fees for Persons Appointed Hearing

    1. 35. Fees for persons appointed hearing

    2. 36. Time for payment under regulation 35

14. 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

15. PART 14

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

16. PART 15 Revocation and Savings

    1. 48. Revocation and savings

    2. 49. Transitional provisions

17. Signature

18. 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

19. Explanatory Note