Amendment of regulation 24 of the principal Regulations13
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 19955; 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.