The Medicines (Products for Animal Use—Fees) Regulations 1997

1. Introductory Text

2. 1. Citation, commencement and scope

3. 2. Interpretation

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

5. 4. Fees relating to applications for assistance in connection with mutual recognition applications

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

7. 6. Applications relating to multiple variations

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

9. 8. Fees relating to application for the renewal of marketing authorisations, product licences, manufacturer’s licences and animal test certificates

10. 9. Fees relating to applications for the 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. Fees relating to 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. Fees payable for the 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 to the Minister

18. 17. Time for payment of fees in connection with applications or inspections and refunds of such 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 and savings

23. 22. Transitional provisions

24. Signature

25. 1. SCHEDULE 1

       FEES RELATING TO APPLICATIONS FOR THE GRANT AND THE 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) and (3) and the original...

          6. 6. Animal test certificates

          7. 7. Manufacturer’s licences

          8. 8. Wholesale dealer’s licences

          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 paragraph 3, 4 and 5, where an application...

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

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

          6. 6. (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 the kind described in...

          3. 3. The fee for an application for the variation of a...

          4. 4. Manufacturer’s licences

          5. 5. Wholesale dealer’s licences

          6. 6. 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 produce 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. Interpretations

       2. 2. Fees

       3. 3. If, following an inspection, it becomes apparent that the inspection...

       4. 4. The fee payable in respect of any inspection of the...

       5. 5. (1) The fee payable in respect of an inspection at...

    3. SCHEDULE 3

       MARKETING AUTHORISATIONS AND PRODUCT LICENCES: ANNUAL FEES

       1. PART I

          1. 1. Calculation of turnover

          2. 2. Where a marketing authorisation or product licence holder sells or...

          3. 3. (1) For the purpose of calculating annual fees for marketing...

          4. 4. For the purpose of calculating annual fees for marketing authorisations...

          5. 5. Where the marketing authorisation or product licence holder fails to...

          6. 6. Where the holder of a marketing authorisation or product licence...

       2. PART II CALCULATION OF ANNUAL FEES

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

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

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

          4. 4. The amount payable by way of annual fees in accordance...

          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...

    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