The Medicines (Fees Relating to Medicinal Products for Animal Use) Regulations 1990

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 THERE WITH

   1. 3. Applications for Licences and Certificates

   2. 4. 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 THERE WITH

   1. 5. Variations of Licences and Certificates

   2. 6. Applications for Multiple Variations

   3. 7. 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 THERE WITH

   1. 8. Renewal of Licences and Certificates

   2. 9. Renewals in terms which are not identical to the existing licence or certificate

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

   1. 10. (1) Subject to paragraph (4) and to regulations 20 and...

7. PART VI FEES FOR TESTING OF BIOLOGICAL MEDICINAL PRODUCTS ON APPLICATION FOR, OR DURING THE CURRENCY OF, A LICENCE OR CERTIFICATE

   1. 11. (1) The fee payable for the testing of a biological...

8. PART VII ANNUAL FEES

   1. 12. Product Licences – annual fee

9. PART VIII REFERENCES TO VETERINARY PRODUCTS COMMITTEE OR TO THE MEDICINES COMMISSION

   1. 13. Product Licences – References

10. PART IX ADMINISTRATION

    1. 14. Payment of fees to Ministers

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

    3. 16. Time for payment of annual fees

    4. 17. Late payment of annual fees

    5. 18. Suspension of Licences

    6. 19. Civil proceedings to recover unpaid fees

    7. 20. Waiver, Reduction or Refund of Fees

11. PART X REVOCATION, SAVINGS AND TRANSITIONAL PROVISIONS

    1. 21. Revocation and Savings

    2. 22. Transitional provisions

12. Signature

13. 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 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), where an application...

          4. 4. Animal Test Certificates

          5. 5. Manufacturers' Licences

          6. 6. Wholesale Dealers' Licences

          7. 7. Certificates of Exemption

       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

          5. 5. Other Variations

       4. PART IV FEES FOR APPLICATIONS FOR RENEWALS OF LICENCES

          1. 1. Product Licences

          2. 2. Manufacturers' Licences

          3. 3. Wholesale Dealers' Licences

          4. 4. Animal Test Certificates

    2. SCHEDULE 2

       FEES FOR INSPECTIONS

       1. 1. Interpretation

       2. 2. Fees

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

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

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

    3. 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...

    4. 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. (1) For the purposes of calculating annual fees for product...

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

          5. 5. (a) For the purpose of satisfying the licensing authority for...

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

          2. Provided that from the date these Regulations come into force...

    5. 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...

14. Explanatory Note