PART 3 Amendments to Schedule 1 to the 2013 Regulations

Amendment to paragraph 33

53.  In paragraph 33 (variation of marketing authorisation)—

(a) omit sub-paragraph (1);

(b) for sub-paragraph (3) substitute—

“(3) An application for a variation under paragraph (2) may only relate to—

(a) a single variation, which may relate to one or more marketing authorisations, or

(b) one or more variations to a single marketing authorisation.”.