PART 2Amendment of the Human Medicines Regulations 2012

Amendment of regulation 27

8.  In regulation 27 (procedure where licensing authority proposes to suspend, revoke or vary licence), for paragraph (5) substitute—

(5) If the licence holder notifies the licensing authority that the holder wishes the licensing authority to submit the proposal to review upon oral representations in accordance with paragraph (3)(b)—

(a)Schedule 5 has effect; and

(b)the licence holder must pay a fee for a review upon oral representations in accordance with the Fees Regulations.