Regulation 13 Amendment of regulation 24 of the principal Regulations

before the definition of “valid notice of amendment”, insert the following definition—

• ““any relevant fee” means, in relation to a notice of amendment, any fee which may be payable in connection with that notice under the Medicines (Products for Human Use—Fees) Regulations 1995^f1; and”; and

in the definition of “valid notice of amendment”, in paragraph (b), for sub-paragraph (ii) substitute the following sub-paragraph—

“(ii)

unless arrangements have been made with the licensing authority for the payment of any relevant fee other than at the time of the request, any such fee.”.