# The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024, Regulation 56: Amendment to regulation 68

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

In regulation 68 (revocation, variation and suspension of UK marketing authorisation or parallel import licence)—
(a) in paragraph (7)—
(i) for sub-paragraph (a) substitute—
“(a) Northern Ireland, in the case of a UKMA(UK)(Category 2) granted under the unfettered access route, and”;
(ii) for sub-paragraph (b) substitute—
“(b) the United Kingdom or an EEA State, in any other case,”;
(b) after paragraph (11G) insert—
“(11H) Condition Q is that, in relation to a UKMA(UK)(Category 2), the licensing authority thinks that a variation is necessary in the interest of patients’ health in the United Kingdom so that the authorisation is treated as a UKMA(UK)(Category 1).
(11I) Condition R is that, in relation to a UKMA(UK)(Category 2), the licensing authority thinks that a variation is necessary in the interest of patients’ health in the United Kingdom so that the authorisation is treated as a UKMA(GB) and separate UKMA(NI).
(A12) Where Condition R is met, and the licence holder requests the cancellation of, or fails to renew, either the UKMA(GB) or UKMA(NI) that result from a variation being made under paragraph 11I, the licensing authority may revoke the corresponding UKMA(NI) or UKMA(GB) that results from that variation.”.

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Source: https://www.legislation.gov.uk/uksi/2024/832/regulation/56 (the official version)
Page: https://openlegislation.uk/human-medicines-amendments-relating-to-the-windsor-framework-regulations-2024/regulation-56
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.