# The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019, Regulation 119: Amendment of regulation 135 (revocation, variation and suspension of traditional herbal registration)

Extent: E+W+S+N.I.

(1) Regulation 135 is amended as follows.
(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), after “states other than EEA states” insert “/ countries other than approved countries for import”.
(3) In paragraph (8)(a) omit “other than the United Kingdom”.
(4) In paragraph (9), in sub-paragraph (b), at the beginning insert “in the case of a THR(NI) or THR(UK),”.
(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).

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Source: https://www.legislation.gov.uk/uksi/2019/775/regulation/119 (the official version)
Page: https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-119
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.