The Medicines (Fees Relating to Medicinal Products for Animal Use) Regulations 1991

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 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 THEREWITH

   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 THEREWITH

   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. Inspections of a site

7. PART VI ANNUAL FEES

   1. 11. Product licences — annual fee

8. PART VII REFERENCES TO VETERINARY PRODUCTS COMMITTEE OR TO THE MEDICINES COMMISSION

   1. 12. Product licences and animal test certificates — references

9. PART VIII ADMINISTRATION

   1. 13. Payment of fees to Ministers

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

   3. 15. Time for payment of annual fees

   4. 16. Late payment of annual fees

   5. 17. Suspension of licences

   6. 18. Civil proceedings to recover unpaid fees

   7. 19. Waiver, reduction or refund of fees

10. PART IX REVOCATION, SAVINGS AND TRANSITIONAL PROVISIONS

    1. 20. Revocation and savings

    2. 21. Transitional provisions

11. Signature

12. 1. SCHEDULE 1

       CAPITAL 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 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. Animal test (confirmation of exemption) certificate

       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 any inspection of the...

       6. 6. 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 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. 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 in any licence year the licence holder does not...

          5. 5. 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...

    5. SCHEDULE 5

       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...

    6. SCHEDULE 6

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

       1. The fee payable under regulation 12 for a reference to...

13. Explanatory Note