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

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PART IVfees for applications for variations of licences or certificates

Product Licences

1.  Subject to paragraph 4, the fee payable under regulation 6(a) in connection with an application for variation of a product licence shall be–

(a)in the case of a complex application £600; and

(b)in any other case £200.

Manufacturers' Licences

2.  Subject to paragraph 4, the fee payable under regulation 6(a) in connection with an application for variation of a manufacturer’s licence shall be–

(a)in the case of a manufacturer’s licence referred to in paragraph 4(2) of Part II of this Schedule, £50;

(b)in any other case, £175.

Wholesale Dealers' Licences

3.  Subject to paragraph 4, the fee payable under regulation 6(a) in connection with an application for variation of a wholesale dealer’s licence shall be £175.

Other Variations

4.  The fee payable under regulation 6(a) in connection with an application for variation of a product licence, a manufacturer’s licence or a wholesale dealer’s licence shall be £50 where–

(a)the variation applied for consists of no more than a change of either or both the name and the address of the holder of the licence; and

(b)in the case of an application for variation of a manufacturer’s licence or a wholesale dealer’s licence only, any change of address does not involve a change of the site of manufacture or wholesale dealing.

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