The Medicines (Products for Human Use) (Fees) Regulations 2012

Manufacturer’s licences or manufacturing authorisations

11.—(1) Unless sub-paragraph (3) applies, the fee payable under regulation 33(3) in connection with the holding of a manufacturer’s licence is £457.

(2) The fee payable under regulation 33(3) in connection with the holding of a manufacturing authorisation is £457.

(3) The fee payable under regulation 33(3) in connection with the holding of a manufacturer’s licence which relates to the import of exempt imported products from a third country is the fee payable in accordance with sub-paragraph (1) and an additional amount calculated in accordance with paragraph 15.