Part 13Consequential provisions

Amendment of the Medicines (Products for Human Use) (Fees) Regulations 2016

regulation 43 + 43.—(1) The Medicines (Products for Human Use) (Fees) Regulations 2016(1) are amended as follows.

(2) In regulation 20—

regulation 43 2 a + (a)in the heading, for “amendments” substitute “modifications”;

regulation 43 2 b + (b)in paragraph (1)—

regulation 43 2 b i + (i)for “valid notice of amendment under regulation 24 (amendments” substitute “modification request under regulation 22 (modifications”;

regulation 43 2 b ii + (ii)for “paragraphs 10 or 11 of Part 2 of Schedule 3 (request for authorisation)” substitute “paragraphs 2 or 5(a) of Part A1 of Schedule 3 (request for approval)”.

(3) In Schedule 2, in Part 4, in paragraph 49, for “notice of amendment relating to an amendment” substitute “modification request relating to a modification”.