The Medicines (Products for Human Use — Fees) Regulations 1991

Fees payable

13.—(1) Subject to paragraph (5) and to regulations 19 and 23, a fee in accordance with paragraphs 2 to 5 of Schedule 2 shall be payable in respect of any inspection of a site made during the currency of a product licence, a manufacturer’s licence or a wholesale dealer’s licence (except for any inspection in respect of which a fee is otherwise payable under Parts III or IV of these Regulations).

(2) Subject to paragraph (4), the fee payable under paragraph (1) in respect of an inspection of a site made during the currency of a manufacturer’s licence or a wholesale dealer’s licence shall be payable by the holder of that licence.

(3) Where a fee is payable under paragraph (1) in respect of an inspection of a site located outside the United Kingdom, the fee shall be payable in equal proportions by each holder of a product licence in which that site is named as a possible site for manufacture of the medicinal product in respect of which the product licence is granted.

(4) In a case where a site located in the United Kingdom is named as a possible site for the manufacture of a medicinal product and in respect of which two or more manufacturers' licences are in force, any fee payable under paragraph (1) shall be payable in equal proportions by the holders of those licences.

(5) No fee shall be payable in respect of any inspection of a site carried out within 6 months of a previous inspection in order to ascertain whether alterations or improvements to the premises concerned which were required in writing by the licensing authority as the result of that previous inspection have been carried out.