# The Human Medicines (Amendment) (No. 2) Regulations 2014, Regulation 11: Amendment of regulation 68


(1) Regulation 68 (revocation, variation and suspension of UK marketing authorisation) is amended as follows.
(2) For paragraph (4) substitute—
“(4) Condition C is that the licensing authority thinks that there has been a breach of—
(a) a term of the authorisation or licence;
(b) in the case of a UK marketing authorisation, a requirement imposed by Part 13 (packaging and leaflets); or
(c) in the case of a parallel import licence, a requirement in relation to packaging and leaflets imposed by the licensing authority.”
(3) For paragraph (5) substitute—
“(5) Condition D is that the licensing authority thinks that a condition to which—
(a) the UK marketing authorisation or parallel import licence is subject by virtue of regulation 59 (conditions of UK marketing authorisations or parallel import licence: general); or
(b) the UK marketing authorisation is subject by virtue of regulations 60 (conditions of UK marketing authorisations: exceptional circumstances) or 61 (conditions of UK marketing authorisations: new obligations post-authorisation),
has not been fulfilled.”
(4) In paragraph (13) for “This” substitute “Except in the case of a parallel import licence, this”.

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Source: https://www.legislation.gov.uk/uksi/2014/1878/regulation/11 (the official version)
Page: https://openlegislation.uk/human-medicines-amendment-no-2-regulations-2014/regulation-11
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.