Amendment of regulation 17 of the principal Regulations

11.  In regulation 17 of the principal Regulations (request for authorisation to conduct a clinical trial)—

(a) in paragraph (2), for “A” substitute “Subject to paragraph (2A), a”; and

(b) after paragraph (2), insert the following paragraph—

“(2A) No fee need accompany a request where arrangements have been made with the licensing authority for payment of the fee referred to in paragraph (2)(b)(ii) other than at the time of request.”.