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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

      1. 1.Interpretation

      2. 2.For the purposes of these Regulations, a clinical trial authorisation...

      3. 3.In these Regulations any reference to an application for the...

    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

        1. 1.Interpretation

        2. 2.General: categories of Applications and Variations

        3. 3.Administrative variation application

        4. 4.Extension application

        5. 5.Complex application

        6. 6.Complex registration application

        7. 7.Complex variation application

        8. 8.Decentralised procedure application

        9. 9.Extended Type II Complex Variation Application

        10. 10.Major application

        11. 11.Mutual recognition procedure incoming application

        12. 12.New excipient variation application

        13. 13.New indication variation application

        14. 14.Parallel Import Licence application

        15. 15.Reclassification variation application

        16. 16.Reduced registration application

        17. 17.Simple application

        18. 18.Standard application

        19. 19.Standard registration application

        20. 20.Standard variation application

        21. 21.Standard variation application for a homoeopathic medicinal product

        22. 22.Type IB and Type II Applications

        23. 23.Type II Complex Variation Application

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

        1. 24.Marketing authorizations

        2. 25.Fees where application includes reclassification

        3. 26.Fees where person holds clinical trial certificate

        4. 27.Joint development

        5. 28.Application for multiple authorizations

        6. 29.Authorisation for a national homoeopathic product

        7. 30.Manufacturer’s licences and authorisations

        8. 31.Wholesale dealer’s licences

        9. 32.Clinical trial authorisations

        10. 33.Traditional herbal registrations

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

        1. 34.Outgoing mutual recognition applications

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

        1. 35.Marketing authorizations

        2. 36.Variation of marketing authorizations

        3. 37.Reclassification of marketing authorizations

        4. 38.Variation of marketing authorization: national homoeopathic products

        5. 39.Variation of parallel import licence

        6. 40.Manufacturer’s authorisations and licences

        7. 41.Variation of manufacturer’s authorisations and licences

        8. 42.Wholesale dealer’s licences

        9. 43.Variation of wholesale dealer’s licence

        10. 44.Clinical trial authorisations

        11. 45.Traditional herbal registrations

        12. 46.Identical variations

        13. 47.Complex Variation Applications

        14. 48.Multiple reclassification variation applications

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

        1. 49.A set of changes

        2. 50.More than one set of changes proposed

      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. 51.Regulatory assistance

        2. 52.Regulatory assistance – same manufacturer

    3. SCHEDULE 3

      FEES FOR INSPECTIONS

      1. 1.General provisions relating to fees for inspections

      2. 2.Fees: general

      3. 3.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: traditional herbal medicinal products

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

      8. 8.Office-based inspections

    4. SCHEDULE 4

      PERIODIC FEES FOR LICENCES

      1. PART 1 Interpretation

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

      2. PART 2 Value of the Product Sold or Supplied

        1. 2.Determining the total value of the product

        2. 3.Manufacturer’s prices

        3. 4.Information requirements

      3. PART 3 Periodic Fees for Marketing Authorizations and Licences

        1. 5.Marketing authorizations

        2. 6.Marketing authorization: where Part 2 of the 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’s 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.Parallel import licences

    5. SCHEDULE 5

      FEES FOR CERTIFICATES OF REGISTRATION

    6. SCHEDULE 6

      TIME FOR PAYMENT OF CAPITAL FEES: SMALL COMPANIES

      1. 1.Interpretation

      2. 2.Major application

      3. 3.Complex application

      4. 4.Multiple application

      5. 5.Outgoing mutual recognition application

      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

    7. SCHEDULE 7

      WAIVER, REDUCTION OR REFUND OF CAPITAL FEES

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

      2. 2.Reclassification

      3. 3.Variation of a 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 a certificate of registration

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

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

      8. 8.Parallel import licence

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

      10. 10.Clinical trial authorisation

      11. 11.Scientific advice: paediatric indications

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

    8. SCHEDULE 8

      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

  19. Explanatory Note

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