Regulation 56 Amendment to regulation 68I1

United Kingdom

In regulation 68 (revocation, variation and suspension of UK marketing authorisation or parallel import licence)^f1—

(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.”.

Annotations

Commencement

I1: Reg. 56 in force at 1.1.2025, see reg. 1(1)

Footnotes

f1: Regulation 68 was amended by S.I. 2013/1855, 2014/1878 and 2019/775 (including that instrument as amended by S.I. 2020/1488).