SCHEDULES

SCHEDULE 2 U.K. Amendment of the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019

PART 5 U.K. Amendment of Part 6 (amendment of Part 6 (certification of homoeopathic products))

80.  In regulation 102 (amendment of regulation 110 (revocation, variation and suspension of certificate of registration))— U.K.

(a) for paragraph (2) substitute—

“(2) In paragraph (7) for “established in the European Union” substitute—

“established in—

(a) the United Kingdom; or

(b) in relation to a COR(NI), either the United Kingdom or the European Union,

in accordance with the requirements of these Regulations.”.”;

(b) after paragraph (2) insert—

“(2A) After paragraph (8A) insert—

“(8B) Condition I is that the licensing authority thinks that the revocation, variation or suspension is necessary or expedient in light of the Protocol on Ireland/Northern Ireland in the withdrawal agreement.”.”.

Commencement Information

I1 Sch. 2 para. 80 in force at 31.12.2020 immediately before IP completion day, see reg. 1