Paragraph 11 Manufacturer's licences or manufacturing authorisations

Unless sub-paragraph (3) applies, the fee payable under regulation 38(1) in connection with the holding of a manufacturer's licence is F1£561.

The fee payable under regulation 38(1) in connection with the holding of a manufacturing authorisation is F2£561.

The fee payable under regulation 38(1) in connection with the holding of a manufacturer's licence which relates to the import of special medicinal 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.