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The Medicines (Products for Human Use) (Fees) Regulations 2016

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  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, EU 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. 10A. Waiver for advice given to small and medium companies

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

  4. PART 3 Capital Fees for Applications for Authorisations, Registrations, Licences or Certificates and for Associated Inspections

    1. 12.Fees for applications for authorisations, registrations, licences or certificates etc.

    2. 13.Fee for application to be included on the list of online sellers of medicines

    3. 14.Fee for applications for additional copy certificates

    4. 15.Fees for applications for certificates and copy certificates by exporters of medicinal products

  5. PART 4 Capital Fees for Assistance in Obtaining Marketing Authorisations in Other EEA States

    1. 16.Meaning of “set of applications”

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

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

  6. PART 5 Capital Fees for Applications for Variations of Authorisations, Registrations and Licences and for Associated Compliance Activities

    1. 19.Fees for variations of authorisations, registrations and licences

    2. 19A.Fees for certification of plasma master files

    3. 19B.Fee for certification of vaccine antigen master files

    4. 19C.Fees for assessment of post-authorisation safety studies

    5. 19D.Fee for carrying out a major safety review

    6. 19E.Fee for assessment of periodic safety update reports

    7. 19F.Fee for testing of samples by the appropriate authority

    8. 19G.Time for payment of fees under regulations 19A to 19F

    9. 20.Fees for amendments to clinical trial authorisations

    10. 21.Fees for notification of changes and reports for broker's registrations

    11. 22.Fees for notification of changes and compliance Reports for active substance registrations

    12. 23.Applications for multiple variations

  7. PART 6 Capital Fees for Assessment of Labels and Leaflets

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

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

    3. 26.Time for payment of fees under regulation 25

  8. PART 7 Capital Fees for Applications for Renewals of Certain Licences, Authorisations and Registrations and for Associated Inspections

    1. 27.Fees for renewals of certain manufacturer's licences

    2. 27A.Fee for renewals of a marketing authorisation

    3. 28.Fees for renewals in terms which are not identical to the existing authorisation, licence or registration

  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 Authorisations

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

  10. PART 9 Capital Fees for Inspections

    1. 30.Fees for inspections

    2. 31.Fees for inspections of pharmacovigilance service providers

    3. 32.Payer of inspection fee (contract laboratories and API manufacturing sites)

    4. 33.Inspections in connection with multiple applications

    5. 34.Fees for inspections relating to good clinical practice in clinical trials

    6. 35.Amount, and time for payment, of inspection fees in respect of an application for a wholesale dealer's licence

    7. 36.Adjustment and refund of inspection fees in respect of a wholesale dealer's licence

    8. 37.Amount, and time for payment, of inspection fees in respect of an application for a broker's registration or an active substance registration

  11. PART 10 Periodic Fees for Authorisations, Registrations and Licences

    1. 38.Periodic fees

    2. 39.Periodic fee for persons included on the list of online sellers of medicines

  12. PART 11 Capital Fees for Application for Membership of Good Clinical Practice Accreditation Scheme and for Certificate of Membership

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

    2. 41.Fees for applications for membership and certificates

  13. PART 12 Capital Fee for a Review Upon Oral Representations or a Person Appointed Hearing

    1. 42.Fee for a review upon oral representations or a person appointed hearing

    2. 43.Time for payment under regulation 42

  14. PART 13 Fees in relation to the Part 6 of the Human Medicines Regulations (certification of homoeopathic medicinal products)

    1. 44.Interpretation

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

    3. 46.Fees for applications for certificates

    4. 47.Fees for variations of certificates

    5. 48.Time for payment of fees

  15. PART 14 Administration

    1. 49.Payment of fees to Ministers

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

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

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

    5. 53.Time for payment of periodic fees

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

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

    8. 56.Refund or waiver of fees under regulation 54 or 55

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

    10. 58.Suspension of licences and authorisations

    11. 59.Civil proceedings to recover unpaid fees

  16. PART 15 Amendments to Other Legislation

    1. 60.Amendment of the Medical Devices (Consultation Requirements) (Fees) Regulations 1995

    2. 61.Amendment of the Medicines for Human Use (Clinical Trials) Regulations 2004

    3. 62.Amendment of the Human Medicines Regulations 2012

  17. PART 16 Revocations and Savings

    1. 63.The Medicines (Products for Human Use) (Fees) Regulations 2013

  18. Signature

  19. SCHEDULES

    1. SCHEDULE 1

      General interpretation provisions

      1. 1.In these Regulations— “the 2001 Directive” means Directive 2001/83/EC of...

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

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

      4. 4.In these Regulations any reference to an application to be...

      5. 5.(1) For the purpose of these Regulations, a company is...

    2. SCHEDULE 2

      Capital fees for applications for, and variations to, marketing authorisations, licences, 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 Authorisations, Licences, Registrations and Certificates

        1. 24.Marketing authorisations

        2. 24A.Fees where an application for a European Union marketing authorisation had been made before IP completion day

        3. 25.Fees where application includes reclassification

        4. 26.Fees where person holds clinical trial certificate

        5. 27.Joint development

        6. 28.Application for multiple authorisations

        7. 28A. Application by pre-assessment of modules

        8. 29.Authorisation for a national homoeopathic product

        9. 30.Manufacturer's licences and authorisations

        10. 31.Wholesale dealer's licences

        11. 32.Broker's registrations

        12. 33.Active substance registrations

        13. 34.Clinical trial authorisations

        14. 35.Traditional herbal registrations

        15. 36.Online sellers of medicines

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

        1. 37.Outgoing mutual recognition applications

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

        1. 38.Marketing authorisations

        2. 39.Variation of marketing authorisations

        3. 39A.Variation of orphan marketing authorisations: small and medium companies

        4. 40.Reclassification of marketing authorisations

        5. 40A.Fees where an application for a variation or an extension of a European Union marketing authorisation had been made before IP completion day

        6. 41.Variation of marketing authorisation: national homoeopathic products

        7. 42.Variation of parallel import licence

        8. 43.Manufacturer's authorisations and licences

        9. 44.Variation of manufacturer's authorisations and licences

        10. 45.Wholesale dealer's licences

        11. 46.Variation of wholesale dealer's licence

        12. 47.Variation of a broker's registration

        13. 48.Variation of an active substance registration

        14. 49.Clinical trial authorisations

        15. 50.Traditional herbal registrations

        16. 51.Identical variations

        17. 52.Complex Variation Applications

        18. 53.Multiple reclassification variation applications

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

        1. 54.A set of changes

        2. 55.More than one set of changes proposed

      6. PART 6 Capital Fee for the Renewal of a Marketing Authorisation

        1. 56.Renewal of a marketing authorisation

        2. 57.Renewal of multiple marketing authorisations

      7. PART 6A Capital Fee for Conducting a Major Safety Review

        1. 57A.The fee payable under regulation 19D(1) in connection with the...

      8. PART 6B Capital Fee for Testing of Samples by the Appropriate Authority

        1. 57B.(1) Unless sub-paragraph (2) applies, the fee payable under regulation...

      9. PART 7 Relevant Substances

        1. 58.Substances listed for the purposes of paragraph 24(2)(b) and (4)(b) and 38(2)(b)

    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.Broker's registrations

      9. 9.Active substance registrations

      10. 10.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 Authorisations and Licences

        1. 5.Marketing authorisations

        2. 6.Marketing authorisation: where Part 2 of the Act applies

        3. 7.Marketing authorisation: 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: special medicinal products

        11. 15.Additional amount for manufacturer's licences and wholesale dealer's licences which relate to special medicinal products

        12. 16.Traditional herbal registrations

        13. 17.Online sellers of medicines

      4. PART 4 Types of Marketing Authorisation 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 authorisation, 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, manufacturer's licence, broker's registration or active substance registration

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

      8. 7A.Orphan marketing authorisation

      9. 8.Parallel import licence

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

      11. 10.Clinical trial authorisation

      12. 11.Scientific advice: paediatric indications

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

    8. SCHEDULE 8

      Adjustment , waiver reduction or refund of periodic fees

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

      2. 2.Adjustment and refund: licences relating to imported special medicinal products

      3. 2A.Waiver or refund: converted EU marketing authorisations

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

  20. Explanatory Note

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