The Medicines (Products for Human Use) (Fees) Regulations 2013

Fees for inspections

29.—(1) Unless regulation 30 or Part 16 of these Regulations applies, a fee is payable in accordance with—

(a) paragraphs 1 to 9 of Schedule 3 for inspection of any site made in connection with an application for, or during the currency of, a marketing authorisation, a traditional herbal registration, a clinical trial authorisation, a manufacturing authorisation, a manufacturer’s licence, a wholesale dealer’s licence, a broker’s registration or an active substance registration except for an inspection for which a fee is payable under regulation 26 or 33;

(b) paragraph 10 of Schedule 3 for any inspection comprising an office-based evaluation and risk assessment of documentation but not involving inspection of a site, in connection with the monitoring of—

(i) good manufacturing practice;

(ii) good clinical practice;

(iii) good pharmacovigilance practice; or

(iv) good distribution practice.

(2) Unless regulation 31 or 32 applies, the fee in paragraph (1) is payable by the holder of, or as the case may be, applicant for, the authorisation, registration or licence in relation to which the inspection is made.