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The Medicines (Products for Human Use) (Fees) Regulations 2012

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  1. Introductory Text

  2. PART 1

    1. 1.Citation and commencement

    2. 2.Interpretation

  3. PART 2

    1. 3.Interpretation of Part 2

    2. 4.Fee for scientific advice: application for, or variation to, EU 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

    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 EEA

    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

    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

    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

    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 registration

  9. PART 8

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

  10. PART 9

    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

    5. 31.Amount, and time for payment, of inspection fees in respect of an application for a wholesale dealer’s licence

    6. 32.Adjustment and refund of inspection fees in respect of a wholesale dealer’s licence

  11. PART 10

    1. 33.Periodic fees

    2. 34.Periodic fees for clinical trial authorisations

  12. PART 11

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

    2. 36.Fees for applications for membership and certificates

  13. PART 12

    1. 37.Fee for a person appointed hearing

    2. 38.Time for payment under regulation 37

  14. PART 13

    1. 39.Interpretation

    2. 40.Fees for applications made at the invitation of the licensing authority

    3. 41.Fees for applications for certificates

    4. 42.Fees for variations of certificates

    5. 43.Time for payment of fees

  15. PART 14

    1. 44.Payment of fees to Ministers

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

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

    4. 47.Payment of fees in respect of a traditional herbal registration

    5. 48.Time for payment of periodic fees

    6. 49.Penalty fees for late payment of periodic fees

    7. 50.Daily penalty fees for late payment of periodic fees

    8. 51.Refund or waiver of fees under regulation 49 or 50

    9. 52.Adjustment, waiver, reduction or refund of fees

    10. 53.Suspension of licences and authorisations

    11. 54.Civil proceedings to recover unpaid fees

  16. PART 15

    1. 55.Amendment of the Medicines for Human Use (Clinical Trials) Regulations 2004

    2. 56.Amendment of the Homoeopathic Regulations

  17. PART 16

    1. 57.The Medicines (Products for Human Use) (Fees) Regulations 2010

    2. 58.The Homoeopathic Regulations

  18. Signature

    1. SCHEDULE 1

      INTERPRETATION

    2. SCHEDULE 2

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

      1. PART 1 General: interpretation and categories of applications and variations

      2. PART 2 Capital Fees for Applications for Authorizations, Licences, Registrations 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

    3. SCHEDULE 3

      FEES FOR INSPECTIONS

    4. SCHEDULE 4

      PERIODIC FEES FOR LICENCES

      1. PART 1 Interpretation

      2. PART 2 Value of the Product Sold or Supplied

      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

    5. SCHEDULE 5

      FEES FOR CERTIFICATES OF REGISTRATION

    6. SCHEDULE 6

      TIME FOR PAYMENT OF CAPITAL FEES: SMALL COMPANIES

    7. SCHEDULE 7

      WAIVER, REDUCTION OR REFUND OF CAPITAL FEES

    8. SCHEDULE 8

      ADJUSTMENT, REDUCTION OR REFUND OF PERIODIC FEES

  19. Explanatory Note

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