# The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020, Paragraph 91

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

In regulation 119 (amendment of regulation 135 (revocation, variation and suspension of traditional herbal registration))—
(a) after paragraph (1) insert—
“(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.”.”;
(b) in paragraph (2), for “for “from states” to the end substitute “after “states other than EEA states” insert “ / countries other than approved countries for import ”.”;
(c) for paragraph (3) substitute—
“(3) In paragraph (8)(a) omit “other than the United Kingdom”.”;
(d) in paragraph (4) for “omit sub-paragraph” to the end substitute “ in sub-paragraph (b), at the beginning insert “in the case of a THR(NI) or THR(UK),”. ”;
(e) after paragraph (4) insert—
“(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.”.”.

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Source: https://www.legislation.gov.uk/uksi/2020/1488/schedule/2/paragraph/91 (the official version)
Page: https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2020/schedule-2/paragraph-91
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.