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 or variation to EC marketing authorization

   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 authorizations

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 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 Revocationand Savings

    1. 48. Revocation and savings

17. Signature

18. 1. SCHEDULE 1

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

       1. PART 1 Interpretation

          1. 1. In this Schedule— “active ingredient” means an ingredient of a...

       2. PART 2 Capital Fees for Applications for Authorizations, Licences and Certificates

          1. 2. Marketing authorizations

          2. 3. Fees where application includes reclassification

          3. 4. Fees where person holds clinical trial certificate

          4. 5. Joint development

          5. 6. Applications for multiple authorisations

          6. 7. Authorisation for a national homoeopathic product

          7. 8. Manufacturer’s licences and authorisations

          8. 9. Wholesale dealer’s licences

          9. 10. Clinical trial authorisations

          10. 11. Traditional herbal registrations

       3. PART 3 Capital Fees for Assistance in Obtaining Marketing Authorizations in Other EEA States

          1. 12. Interpretation

          2. 13. Outgoing mutual recognition applications

       4. PART 4 Capital Fees for Applications for Variations of Authorizations, Licences and Registrations

          1. 14. Interpretation

          2. 15. Marketing authorizations

          3. 16. Variation of marketing authorizations

          4. 17. Reclassification of marketing authorizations

          5. 18. Variation of marketing authorization: natural homoeopathic products

          6. 19. Variation of parallel import licence

          7. 20. Manufacturer’s authorisations and licences

          8. 21. Variation of manufacturer’s authorisations and licences

          9. 22. Wholesale dealer’s licences

          10. 23. Variation of wholesale dealer’s licence

          11. 24. Clinical trial authorisations

          12. 25. Traditional herbal registrations

          13. 26. Identical variations

          14. 27. Complex Variation Applications

          15. 28. Multiple reclassification variation applications

       5. PART 5 Capital Fees for Assessment of Labels and Leaflets

          1. 29. Interpretation

          2. 30. Single set of changes

          3. 31. More than one set of charges purposed

       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

          1. 32. Regulatory assistance

          2. 33. Regulatory assistance – same manufacturer

    2. SCHEDULE 2

       FEES FOR INSPECTIONS

       1. 1. In this Schedule— (a) if an inspection is made at...

       2. 2. Fees: general

       3. 3. Third country traditional herbal medicinal products

       4. 4. Sites concerned with starting materials for traditional herbal medicinal products

       5. 5. Wholesale dealer’s licence: general

       6. 6. Wholesale dealer’s licence: third country traditional herbal medicinal products

       7. 7. Wholesale dealer’s licences: inspection of short duration

    3. SCHEDULE 3

       PERIODIC FEES FOR LICENCES

       1. PART 1 Interpretation

          1. 1. In this Schedule— “anthroposophic product” means a medicinal product prepared...

       2. PART 2 Calculation of Turnover

          1. 2. Calculation of turnover

          2. 3. Manufacturer’s prices

          3. 4. Evidence of turnover

       3. PART 3 Periodic Fees for Marketing Authorizations and Licences

          1. 5. Marketing authorizations

          2. 6. Marketing authorization: where Part 2 of Act applies

          3. 7. Marketing authorization: derivatives

          4. 8. Number of fee periods

          5. 9. Authorisation for two or more kinds of medicinal product

          6. 10. Reduced fees

          7. 11. Manufacturer’s licences or manufacturing authorisations

          8. 12. Wholesale dealer’s licences

          9. 13. Wholesale dealer’s licences: evidence

          10. 14. Wholesale dealer licences: exempt imported products

          11. 15. Additional amount for manufacturer’s licences and wholesale dealer’s licences which relate to exempt imported products

          12. 16. Clinical trial authorisations

          13. 17. Traditional herbal registrations

       4. PART 4 Types of Marketing Authorization for which only One Periodic Fee is Payable

          1. 18. Specified parallel import licences

    4. SCHEDULE 4

       Time for Payment of Capital Fees

       1. 1. Application by or on behalf of a small company

       2. 2. Major application

       3. 3. Complex application

       4. 4. Multiple applications

       5. 5. Outgoing mutual recognition applications

       6. 6. Application for traditional herbal registration

       7. 7. Traditional herbal registration: complex variation

       8. 8. Application for manufacturer’s licence, manufacturing authorisation or wholesale dealer’s licence

       9. 9. Inspection fees in connection with applications

    5. SCHEDULE 5

       WAIVER, REDUCTION OR REFUND OF CAPITAL FEES

       1. 1. Interruptions of manufacture, assembly, sale or supply

       2. 2. Reclassification

       3. 3. Traditional herbal registration

       4. 4. Withdrawal of application in relation to marketing authorization, traditional herbal registration or clinical trial authorisation

       5. 5. Withdrawal of application in relation to manufacturing authorisation, wholesale dealer’s or manufacturer’s licence

       6. 6. Refusal of application for grant of marketing authorization, traditional herbal registration or clinical trial authorisation

       7. 7. Parallel import licence

       8. 8. Surrender of marketing authorization at same time as a variation application

       9. 9. Clinical trial authorisation

       10. 10. Scientific advice: paediatric indications

    6. SCHEDULE 6

       ADJUSTMENT, REDUCTION OR REFUND OF PERIODIC FEES

       1. 1. Refund on surrender or revocation of authorization, registration or licence

       2. 2. Adjustment and refund: licences relating to exempt imported products

       3. 3. Refunds: treated as having been paid on account

    7. SCHEDULE 7

       REVOCATION SCHEDULE

19. Explanatory Note