Amendment of regulation 24 of the principal Regulations
This section has no associated Explanatory Memorandum
13. In regulation 24 of the principal Regulations (amendments by the sponsor), in paragraph (10)—
(a)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(1); and”; and
(b)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.”.