The Medicines (Fees Relating to Medicinal Products for Animal Use) Regulations 1989

1. Introductory Text

2. PART I GENERAL

   1. 1. Citation, commencement and scope

   2. 2. Interpretation

3. PART II CAPITAL FEES FOR APPLICATIONS FOR LICENCES OR CERTIFICATES AND FOR INSPECTIONS IN CONNECTION THEREWITH

   1. 3. Applications for Licences

   2. 4. Applications for Animal Test Certificates

   3. 5. Applications for certificates for exports of medicinal products

4. PART III FEES FOR APPLICATIONS FOR VARIATIONS OF LICENCES OR CERTIFICATES AND FOR INSPECTIONS IN CONNECTION THEREWITH

   1. 6. Variations of Licences

   2. 7. Variations of Animal Test Certificates

   3. 8. Applications for Multiple Variations

   4. 9. Variations at the Invitation of the Licensing Authority

5. PART IV FEES FOR APPLICATIONS FOR RENEWALS OF LICENCES OR CERTIFICATES AND FOR INSPECTIONS IN CONNECTION THEREWITH

   1. 10. Renewal of Licences

   2. 11. Renewal of Certificates

   3. 12. Renewals in terms which are not identical to the existing licence or certificate

6. PART V FEES FOR INSPECTIONS MADE DURING THE CURRENCY OF A LICENCE

   1. 13. (1) Subject to paragraph (4) and to regulations 22 and...

7. PART VI FEES FOR BATCH CONTROL TESTING DURING THE CURRENCY OF A LICENCE

   1. 14. (1) A fee calculated in accordance with paragraph (2) shall...

8. PART VII ANNUAL FEES

   1. 15. Product Licences—annual fee

   2. 16. Payment of fees to Ministers

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

   4. 18. Time for payment of annual fees

   5. 19. Late payment of annual fees

   6. 20. Suspension of Licences

   7. 21. Civil proceedings to recover unpaid fees

   8. 22. Waiver, Reduction or Refund of Fees

9. PART IX REVOCATION, SAVINGS AND TRANSITIONAL PROVISIONS

   1. 23. Revocation and Savings

   2. 24. Transitional provisions

10. Signature

11. 1. SCHEDULE 1

       CAPITAL FEES FOR APPLICATIONS, VARIATIONS AND RENEWALS OF LICENCES

       1. PART I interpretation

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

       2. PART II capital fees for applications for licences

          1. 1. Product Licences

          2. 2. Where a major or a complex application is made by...

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

          4. 4. Manufacturers' Licences

          5. 5. Wholesale Dealers' Licences

       3. PART III capital fees for sample testing in connection with applications for licences

       4. PART IV fees for applications for variations of licences or certificates

          1. 1. Product Licences

          2. 2. Manufacturers' Licences

          3. 3. Wholesale Dealers' Licences

          4. 4. Other Variations

       5. PART V fees for applications for renewals of licences

          1. 1. Product Licences

          2. 2. Manufacturers' Licences

          3. 3. Wholesale Dealers' Licences

          4. 1. Interpretation

          5. 2. Fees

          6. 3. (1) Subject to paragraph (2), unless the applicant or, as...

          7. 4. In the case of an inspection in connection with the...

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

    2. SCHEDULE 3

       WAIVER, REDUCTION OR REFUND OF CAPITAL 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), where the Licensing...

       4. 4. Where an application for the grant or renewal of a...

       5. 5. (1) Subject to sub-paragraph (2), where an application for a...

    3. SCHEDULE 4

       ANNUAL FEES FOR PRODUCT LICENCES

       1. PART I calculation of turnover

          1. 1. In relation to the calculation of turnover in any calendar...

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

          3. 3. For the purpose of calculating annual fees for product licences...

          4. 4. (a) For the purpose of satisfying the Licensing Authority for...

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

       2. PART II calculation of annual fees

          1. 1. Subject to the provisions of these Regulations annual fees shall...

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

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

          4. 4. Where an application is made by an applicant who was...

          5. 5. Where a licence holder has duly paid an annual fee...

          6. 6. Where applications are made on more than one occasion in...

          7. 7. Where in any licence year the licence holder does not...

          8. 8. Where the holder of, or an applicant for a product...

       3. PART III lesser amounts of fees

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

          2. 2. For the purposes of paragraph 1, “emergency vaccines” means (a)...

    4. SCHEDULE 5

       ADJUSTMENT OR REFUND OF ANNUAL FEES

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

       2. 2. Where, after payment of any annual fee payable in accordance...

       3. 3. In addition to the refunds (if any) payable under the...

       4. 4. Where, after the payment of the whole or part of...

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

    5. SCHEDULE 6

       REVOCATIONS

12. Explanatory Note