The Medicines (Products for Animal Use—Fees) Regulations 1998

1. Introductory Text

2. 1. Citation, commencement and scope

3. 2. Interpretation

4. 3. Applications for the grant of marketing authorisations, product licences, manufacturer’s licences, wholesale dealer’s licences and animal test certificates

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

6. 5. Applications for variation of marketing authorisations, product licences, manufacturer’s licences, wholesale dealer’s licences and animal test certificates

7. 6. Multiple variations

8. 7. Variation at the invitation of the relevant authority

9. 8. Applications for renewal of marketing authorisations, product licences, manufacturers' licences and animal test certificates

10. 9. Applications for renewal of marketing authorisations, product licences, manufacturer’s licences and animal test certificates in terms which are not identical to the existing marketing authorisation, licence or certificate

11. 10. Site inspections

12. 11. Marketing authorisations and product licences: annual fees

13. 12. Manufacturer’s licences: annual fees

14. 13. Wholesale dealer’s licences: annual fees

15. 14. Registration of Homoeopathic Veterinary Medicinal Products

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

17. 16. Payment of fees

18. 17. Time for payment of fees

19. 18. Late payment of annual fees

20. 19. Suspension of licences and certificates

21. 20. Waiver, reduction or refund of fees

22. 21. Revocation

23. 22. Transitional provisions

24. Signature

25. 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 I INTERPRETATION

       2. PART II

          FEES RELATING TO APPLICATIONS FOR THE GRANT OF MARKETING AUTHORISATIONS, PRODUCT LICENCES, MANUFACTURER'S LICENCES, WHOLESALE DEALER'S LICENCES AND ANIMAL TEST CERTIFICATES

          1. 1. Marketing authorisations and product licences

          2. 2. The fee for an application for an Article 15.2 marketing...

          3. 3. Where an application for a marketing authorisation is made by...

          4. 4. Where– (a) a major or a complex application is made...

          5. 5. (1) Subject to sub-paragraphs (2), (3) and (4) below, where...

          6. 6. Manufacturer’s licences

          7. 7. Wholesale dealer’s licences

          8. 8. Animal test certificates

          9. 9. Marketing authorisation (parallel import)

       3. PART III FEES RELATING TO APPLICATIONS FOR ASSISTANCE IN CONNECTION WITH MUTUAL RECOGNITION APPLICATIONS

          1. 1. Subject to paragraphs 3 and 4, where an application for...

          2. 2. Where an application for assistance in connection with a mutual...

          3. 3. Where an application for assistance in connection with a mutual...

          4. 4. Where an application for assistance in connection with a mutual...

          5. 5. (1) Where an application for assistance in connection with a...

       4. PART IV 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. Marketing authorisations (other than mutually recognised marketing authorisations) and product licences

          2. 2. The fee for an application of a kind described in...

          3. 3. Mutually recognised marketing authorisations

          4. 4. The fee for an application for a connected variation, that...

          5. 5. Manufacturer’s licences

          6. 6. Wholesale dealer’s licences

          7. 7. Animal test certificates

       5. PART V FEES RELATING TO APPLICATIONS FOR THE RENEWAL OF MARKETING AUTHORISATIONS, PRODUCT LICENCES, MANUFACTURER'S LICENCES AND ANIMAL TEST CERTIFICATES

          1. 1. Marketing authorisations and product licences

          2. 2. Manufacturer’s licences

          3. 3. Animal test certificates

          4. 4. Article 15.2 marketing authorisations

    2. SCHEDULE 2

       FEES RELATING TO SITE INSPECTIONS

       1. 1. Interpretation

       2. 2. Fees

       3. 3. (1) The fee payable for any inspection of either or...

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

    3. SCHEDULE 3

       MARKETING AUTHORISATIONS AND PRODUCT LICENCES: ANNUAL FEES

       1. PART I

          1. 1. Calculation of turnover

          2. 2. To the extent that a marketing authorisation or product licence...

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

          4. 4. (1) The relevant authority may require a marketing authorisation or...

       2. PART II CALCULATION OF ANNUAL FEES

          1. 1. In the case of a business with a turnover of...

          2. 2. In the case of a business with a turnover of...

          3. 3. For the purpose of calculating annual turnover the provisions of...

          4. 4. The amount payable by way of an annual fee in...

          5. 5. If a marketing authorisation or product licence holder does not...

       3. PART III CALCULATION OF ANNUAL FEE—EMERGENCY VACCINES

    4. SCHEDULE 4

       MARKETING AUTHORISATIONS AND PRODUCT LICENCES: ADJUSTMENT OR REFUND OF ANNUAL FEES

       1. 1. Where an annual fee calculated in accordance with paragraph 5...

       2. 2. Any sums payable to an applicant by way of refund...

    5. SCHEDULE 5

       FEES RELATING TO APPLICATIONS FOR REGISTRATION OF HOMOEOPATHIC VETERINARY MEDICINAL PRODUCTS

       1. PART I INTERPRETATION

       2. PART II FEES RELATING TO APPLICATIONS FOR REGISTRATION

          1. 1. Subject to paragraph 2, the fee for an application of...

          2. 2. Where an application for registration relates to a product–

       3. PART III WAIVER OR REFUND OF FEES

          1. 1. Subject to paragraph 2, where an application for registration is...

          2. 2. If an application for registration is withdrawn either after veterinary,...

    6. SCHEDULE 6

       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 payable under regulation 15 for a reference to...

       2. 2. The fee payable under regulation 15 for a reference to...

       3. 3. For the purposes of this Schedule, the terms– “complex application”;...

    7. SCHEDULE 7

       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) Subject to sub-paragraphs (2) to (5) below, where the...

       4. 4. (1) Subject to sub-paragraph (2) below, where an application for...

26. Explanatory Note