The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024
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Change 1
56 Amendment to regulation 68
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. .
56 Amendment to regulation 68
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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