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

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PART IIIFEES FOR APPLICATIONS FOR VARIATIONS OF LICENCES OR CERTIFICATES AND FOR INSPECTIONS IN CONNECTION THEREWITH

Variations of Licences

6.  Subject to regulations 8, 9, 22 and 24, in connection with an application under section 30 of the Act for the variation of a provision of a product licence, a manufacturer’s licence or a wholesale dealer’s licence, there shall be payable by the applicant–

(a)the fee prescribed in Part IV of Schedule 1; and

(b)in respect of any inspection of a description referred to in paragraph 1 of Schedule 2 made in connection with that application, the fee payable in accordance with paragraphs 2 to 5 of that Schedule.

Variations of Animal Test Certificates

7.—(1) Subject to paragraph (2) and regulations 8, 9, 22 and 24, in connection with an application under section 39(4) of the Act for the variation of a provision of an animal test certificate, there shall be payable by the applicant a fee of £200.

(2) Where an application is made for a variation to a provision of the animal test certificate and the variation applied for consists of no more than a change of either or both the name and address of the holder of the certificate, there shall be payable by the applicant a fee of £50.

Applications for Multiple Variations

8.  A separate fee shall be payable in respect of each variation of each provision of a licence or certificate applied for in any one application except that no separate fee shall be payable in respect of any variation which is related to or is consequential upon another variation of a provision of the same licence or certificate which is applied for in the same application.

Variations at the Invitation of the Licensing Authority

9.  Where an application for a variation is made at the express written invitation of the Licensing Authority, no fee shall be payable under this Part of these Regulations.

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