xmlns:atom="http://www.w3.org/2005/Atom" xmlns:atom="http://www.w3.org/2005/Atom"

  1. Introductory Text

  2. 1.Citation, commencement and scope

  3. 2.Interpretation

  4. 3.Applications for authorisations, licences and certificates

  5. 4.Specific batch control

  6. 5.Applications for assistance in connection with mutual recognition

  7. 6.Applications for variation of authorisations, licences and certificates

  8. 7.Applications for renewal of authorisations, licences and certificates

  9. 8.Site inspections

  10. 9.Marketing authorisations and product licences: annual fees

  11. 10.Manufacturer’s licences: annual fees

  12. 11.Wholesale dealer’s licences: annual fees

  13. 12.Registration of homoeopathic veterinary medicinal products

  14. 13.Fees for references to the Veterinary Products Committee or to the Medicines Commission

  15. 14.Payment of fees

  16. 15.Late payment of annual fees

  17. 16.Suspension of licences and certificates

  18. 17.Waiver, reduction or refund of fees

  19. 18.Revocation

  20. 19.Transitional provisions

  21. Signature

    1. SCHEDULE 1

      Fees relating to applications for the grant, variation and renewal of marketing authorisations, product licences, manufacturer’s licences, wholesale dealer’s licences and animal test certificates

      1. PART 1 Interpretation

      2. PART 2 Fees Relating to Applications for the Grant of Marketing Authorisations, Product Licences, Manufacturer’s Licences, Wholesale Dealer’s Licences, Animal Test Certificates and Export Certificates

        1. Marketing authorisations and product licences

          1. 1.The fee for an application is that specified in the...

          2. 2.Paragraph 1 shall not apply where an application for a...

          3. 3.(1) This paragraph applies to fees which would, but for...

        2. Manufacturer’s licences

          1. 4.(1) The fee for an application for a manufacturer’s licence...

        3. Wholesale dealer’s licences

          1. 5.(1) The fee for an application for a wholesale dealer’s...

        4. Animal test certificates

          1. 6.The fee for an Animal Test Certificate—Type A application is...

        5. Marketing authorisations (parallel import)

          1. 7.The fee for an application for a marketing authorisation (parallel...

        6. Export Certificates

          1. 8.The fee for an application for an export certificate is...

      3. PART 3 Fees Relating to Applications for Assistance in Connection with Mutual Recognition Applications

        1. 1.(1) The fee for an application for assistance in connection...

        2. 2.(1) The fee for an application for assistance in connection...

      4. PART 4 Fees Relating to Applications for the variation of Marketing Authorisations, Product Licences, Manufacturer’s Licences, Wholesale Dealer’s Licences and Animal Test Certificates

        1. 1.The application fee for a variation to a marketing authorisation...

        2. 2.The application fee for any other variation to a marketing...

        3. Mutually recognised marketing authorisations

          1. 3.(1) The fee for an application for the variation of...

        4. Manufacturer’s licences

          1. 4.The fee for an application for the variation of a...

        5. Wholesale dealer’s licences

          1. 5.The fee for an application for a variation of a...

        6. Animal test certificates

          1. 6.The fee for an application for the variation of an...

      5. PART 5 Fees Relating to Applications for the Renewal of Marketing Authorisations, Product Licences, Manufacturer’s Licences and Animal Test Certificates

        1. Marketing authorisations and product licences

          1. 1.The fee for an application to renew a marketing authorisation...

        2. Manufacturer’s licences

          1. 2.The fee for an application to renew a manufacturer’s licence...

        3. Animal test certificates

          1. 3.The fee for an application to renew an animal test...

        4. Article 26.3 marketing authorisations

          1. 4.Where an Article 26.3 marketing authorisation is renewed, paragraph 1...

    2. SCHEDULE 2

      Fees relating to site inspections

      1. Interpretation

        1. 1.(1) In this Schedule— “biological product” has the same meaning...

      2. Fees

        1. 2.(1) The fee for an inspection is that specified in...

        2. 3.(1) Paragraph 2 does not apply to an inspection concerned...

        3. 4.(1) The fee payable for an inspection at a site...

    3. SCHEDULE 3

      Marketing authorisations and product licences: annual fees

      1. Calculation of turnover

        1. 1.For the purpose of calculating any annual fee payable in...

        2. 2.(1) The relevant authority may require a marketing authorisation or...

      2. Calculation of annual fees

        1. 3.(1) The annual fee shall be— (a) in the case...

        2. 4.Where this paragraph applies, the annual fee payable by the...

        3. 5.Where an annual fee calculated in accordance with paragraph 4...

        4. 6.Any sums payable to a person by way of refund...

    4. SCHEDULE 4

      Fees relating to applications for registration of homoeopathic veterinary medicinal products

      1. Interpretation

        1. 1.In this Schedule— “formulation”, in relation to a product, does...

      2. Fees relating to applications for registration

        1. 2.The fee for a registration application is that specified in...

        2. 2A.(1) Paragraph 2 does not apply where a registration application...

      3. Waiver or refund of fees

        1. 3.(1) Where an application for registration is withdrawn before determination...

    5. SCHEDULE 5

      Marketing authorisations, product licences and animal test certificates: fees for references to the Veterinary Products Committee or to the Medicines Commission

      1. 1.The fee for a reference to the Veterinary Products Committee...

      2. 2.For the purposes of this Schedule, the terms— “complex”; “major”;...

    6. SCHEDULE 6

      Waiver, reduction or refund of fees

      1. 1.Where the manufacture, assembly, sale or supply of products of...

      2. 2.The relevant authority may waive or reduce the payment of...

      3. 3.(1) Where the relevant authority— (a) is satisfied that the...

      4. 4.(1) Where an application for a marketing authorisation or product...

  23. Explanatory Note