The Medicines (Fees Relating to Medicinal Products for Animal Use) Regulations 1994

2. Introductory Text

1. Citation, commencement and scope

3. 2. Interpretation

4. 3. Applications for licences and certificates

5. 4. Applications for multiple variations

6. 5. Variations at the invitation of the licensing authority

7. 6. Renewals in terms which are not identical to the existing licence or certificate

8. 7. Inspections of a site

9. 8. Product licences: annual fee

10. 9. Manufacturers' licences: annual fees

11. 10. Wholesale dealers' licences: annual fees

12. 11. Product licences and animal test certificates: references

13. 12. Payment of fees to the Minister

14. 13. Time for payment of fees in connection with applications or inspections and refunds of such fees

15. 14. Late payment of annual fees

16. 15. Suspension of licences

17. 16. Waiver, reduction or refund of fees

18. 17. Revocation and savings

19. 18. Transitional provisions

20. Signature

21. 1. SCHEDULE 1

       FEES FOR APPLICATIONS, VARIATIONS AND RENEWALS OF LICENCES

       1. PART I INTERPRETATION

          1. In this Schedule— “active ingredient” means the ingredient of a...

       2. PART II FEES FOR APPLICATIONS FOR LICENCES AND CERTIFICATES

          1. 1. Product licences

          2. 2. Where— (a) a major or a complex application is made...

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

          4. 4. Animal test certificates

          5. 5. Manufacturers' licences

          6. 6. Wholesale dealers' licences

       3. PART III FEES FOR APPLICATIONS FOR VARIATIONS OF LICENCES OR CERTIFICATES

          1. 1. Product licences

          2. 2. Manufacturers' licences

          3. 3. Wholesale dealers' licences

          4. 4. Animal test certificates

       4. PART IV FEES FOR APPLICATIONS FOR RENEWALS OF LICENCES

          1. 1. Product licences

          2. 2. Manufacturers' licences

          3. 3. Animal test certificates

    2. SCHEDULE 2

       FEES FOR INSPECTIONS

       1. 1. Interpretation

       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. The fee payable in respect of an inspection at a...

    3. SCHEDULE 3

       ANNUAL FEES FOR PRODUCT LICENCES

       1. PART I

          1. 1. Calculation of Turnover

          2. 2. Where a licence holder sells or supplies medicinal products which...

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

          4. 4. For the purpose of calculating annual fees for product licences,...

          5. 5. Where the licence holder fails to furnish evidence of the...

          6. 6. Where an applicant for a licence was not dealing in...

       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 licence holder does not submit evidence of turnover...

       3. PART III CALCULATION OF ANNUAL FEE —EMERGENCY VACCINES

          1. Where the holder of a product licence sells or supplies...

    4. SCHEDULE 4

       ADJUSTMENT OR REFUND OF ANNUAL FEES

       1. 1. Where an annual fee has been paid in accordance with...

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

    5. SCHEDULE 5

       FEES FOR REFERENCES TO THE VETERINARY PRODUCTS COMMITTEE OR TO THE MEDICINES COMMISSION

       1. 1. The fee payable under regulation 11 for a reference to...

       2. 2. The fee payable under regulation 11 for a reference to...

    6. SCHEDULE 6

       WAIVER, REDUCTION OR REFUND OF FEES

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

       2. 2. The licensing 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...

22. Explanatory Note