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.