Regulation 119 Amendment of regulation 135 (revocation, variation and suspension of traditional herbal registration)I1
United Kingdom
Regulation 135 M1 is amended as follows.
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.”.
In paragraph (7)(b), F2after “states other than EEA states” insert “/ countries other than approved countries for import”.
In paragraph (8)(a) omit “other than the United Kingdom”.
In paragraph (9), F4in sub-paragraph (b), at the beginning insert “in the case of a THR(NI) or THR(UK),”.
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.”.
Omit paragraph (11).
Annotations
Textual amendments
- F1
Reg. 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)
- F2
Words 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)
- F3
Reg. 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)
- F4
Words 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)
- F5
Reg. 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)
Marginal citations
- M1
Regulation 135 was amended by S.I. 2013/1855.
Commencement
- I1
Reg. 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