The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024

Amendment to regulation 68

56.  In regulation 68 (revocation, variation and suspension of UK marketing authorisation or parallel import licence)(1)—

(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.”.

(1)

Regulation 68 was amended by S.I. 2013/1855, 2014/1878 and 2019/775 (including that instrument as amended by S.I. 2020/1488).