The Veterinary Medicines Regulations 2013

Application for an authorisation to manufacture an autogenous vaccine or a product for administration under the cascadeU.K.

This section has no associated Explanatory Memorandum

30.—(1) The fee for an application for a standard authorisation to manufacture an autogenous vaccine or a veterinary medicinal product for administration under the cascade is—

(a)£3,435 for a site in the United Kingdom;

(b)£3,270 for a site outside the United Kingdom.

(2) The fee for each inspection after a standard authorisation has been granted is (in each case) the same as the fee specified in paragraph (1).

(3) In the case of an application for an individual authorisation to manufacture a single batch of autogenous vaccine, or a single batch of veterinary medicinal product for administration under the cascade the fee is £1,635.

(4) The fee to vary an authorisation is £305 if no further inspection is required, and otherwise is the full application fee.