The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020

This adran has no associated Memorandwm Esboniadol

91.  In regulation 119 (amendment of regulation 135 (revocation, variation and suspension of traditional herbal registration))—U.K.

(a)after paragraph (1) insert—

(1A) For paragraph (6) substitute—

(6) Condition E is that the holder of the registration has ceased to be established in—

(a)the United Kingdom; or

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

in accordance with the requirements of these Regulations..;

(b)in paragraph (2), for “for “from states” to the end substitute “after “states other than EEA states” insert “ / countries other than approved countries for import ”.”;

(c)for paragraph (3) substitute—

(3) In paragraph (8)(a) omit “other than the United Kingdom”.;

(d)in paragraph (4) for “omit sub-paragraph” to the end substitute “ in sub-paragraph (b), at the beginning insert “in the case of a THR(NI) or THR(UK),”. ”;

(e)after paragraph (4) insert—

(4A) After paragraph (10A) insert—

(10B) Condition K 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

I1Sch. 2 para. 91 in force at 31.12.2020 immediately before IP completion day, see reg. 1