OpenLegislation

Regulation 119 Amendment of regulation 135 (revocation, variation and suspension of traditional herbal registration)I1

United Kingdom

(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).

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