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

Time for payment of capital fees in connection with applications or inspections

45.—(1) All capitals fees under these Regulations shall be payable in accordance with—

(a) the specified provisions in paragraph (2) where appropriate, and

(b) paragraph (3).

(2) The specified provisions are—

(a) regulation 10 (pre-application meetings);

(b) regulation 16 (regulatory assistance);

(c) regulation 22 (change to labels and leaflets);

(d) regulation 31 (inspections in respect of wholesale dealer’s licence);

(e) regulation 37 (person appointed hearings); and

(f) regulation 46 (small companies).

(3) All fees payable under this regulation—

(a) in respect of inspections made either in connection with an application for, or during the currency of, an authorization, licence or certificate must be paid within a period of 14 days commencing on the date of the written notice issued by the licensing authority requiring payment of those fees; and

(b) in connection with any application, must have been paid at the time of the application or before.