# The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019, Regulation 77: Amendment of regulation 68 (revocation, variation and suspension of UK marketing authorisation or parallel import licence)

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

(1) Regulation 68 is amended as follows.
(2) In paragraph (5), after “exceptional circumstances)”, insert “ , regulation 60A (conditions as to testing of samples by the appropriate authority) ”.
(3) In paragraph (7)—
(a) after “authorisation” insert “ or licence ”; and
(b) for “established in the European Union” substitute—
“established in—
(a) the United Kingdom; or
(b) in relation to a UKMA(NI), either the United Kingdom or the European Union,
in accordance with the requirements of these Regulations.”.
(4) In paragraph (8)(b), for “states other than EEA states” substitute “ countries other than approved countries for import ”.
(5) In paragraph (9)(a) omit “other than the United Kingdom”.
(6) In paragraph (10)—
(a) in sub-paragraph (a) for “authorisation; or” substitute “ authorisation or licence. ”; and
(b) omit sub-paragraph (b).
(7) In paragraph (11)(a), after authorisation insert “ or licence ”.
(8) After paragraph (11A), insert—
“(11B) Condition L is that the licensing authority thinks that the term of the authorisation which specifies the way in which the product is to be made available, as described in regulation 62(1), is incorrect.
(11C) Condition M is that, in respect of a parallel import licence, the UK marketing authorisation in respect of the medicinal product that was specified in the application for that licence under paragraph 4 of Schedule 8A, has been varied, suspended or revoked by the licensing authority under this regulation.
(11D) Condition N is that, in respect of a parallel import licence, the licensing authority is no longer satisfied that the product is essentially similar to a product that has been granted a UK marketing authorisation.
(11E) The licensing authority may not exercise its powers under paragraph (1) by virtue of the condition in paragraph (11D)—
(a) before the end of the period of one year beginning with IP completion day; and
(b) in any event, in a way that prevents the import of any medicinal product in respect of which a qualified person undertook the certification referred to in Article 51(3) of the 2001 Directive before IP completion day.
(11F) Condition O is that the licensing authority thinks that a variation of a UK marketing authorisation is necessary as a result of the submission of the results of a study by the holder of that authorisation under regulation 78A(14).
(11G) Condition P 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. ”.
(9) In paragraph (12)—
(a) after “UK marketing authorisation”, insert “ or parallel import licence ”; and
(b) after “an authorisation” insert “ or licence ”.
(10) Omit paragraph (13).

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Source: https://www.legislation.gov.uk/uksi/2019/775/regulation/77 (the official version)
Page: https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-77
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.