The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019

Amendment of regulation 135 (revocation, variation and suspension of traditional herbal registration)U.K.

This section has no associated Explanatory Memorandum

119.—(1) Regulation 135 M1 is amended as follows.

[F1(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..]

(2) In paragraph (7)(b), [F2after “states other than EEA states” insert “/ countries other than approved countries for import”.]

[F3(3) In paragraph (8)(a) omit “other than the United Kingdom”.]

(4) In paragraph (9), [F4in sub-paragraph (b), at the beginning insert “in the case of a THR(NI) or THR(UK),”.]

[F5(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..]

(5) Omit paragraph (11).

Textual Amendments

F1Reg. 119(1A) 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. 91(a)

F2Words in reg. 119(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. 91(b)

F3Reg. 119(3) 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. 91(c)

F4Words in reg. 119(4) 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. 91(d)

F5Reg. 119(4A) 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. 91(e)

Commencement Information

I1Reg. 119 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Marginal Citations

M1Regulation 135 was amended by S.I. 2013/1855.