Regulation 102 Amendment of regulation 110 (revocation, variation and suspension of certificate of registration)I1

United Kingdom

(1)

Regulation 110 M1 is amended as follows.

F1(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.”.

F2(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.”.

(3)

Omit paragraph (10).

Annotations

Textual amendments

F1: Reg. 102(2) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 80(a)
F2: Reg. 102(2A) inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 80(b)

Marginal citations

M1: Regulation 110 was amended by S.I.2013/1855.

Commencement

I1: Reg. 102 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1