[F1Protocols relating to coronavirus and influenza vaccinations and immunisationsU.K.
247A.—(1) Regulations 214, 220 and 221 do not apply to the supply or administration of a medicinal product used for vaccination or immunisation against coronavirus or influenza virus (of any type) that meets the following conditions.
F2(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(3) Condition B is that the supply or administration is in accordance with the requirements of a protocol that is approved by the Secretary of State, the Scottish Ministers, the Welsh Ministers or the Minister of Health in Northern Ireland.
(4) Condition C is that the protocol specifies (amongst other matters)—
(a)the classes of persons permitted to administer medicinal products under the protocol;
(b)the process by which a person of the specified class is designated, and by whom, as a person authorised to administer medicinal products under the protocol;
(c)requirements as to the recording of the name of a person who, on any particular occasion, administers a medicinal product under the protocol; and
(d)requirements, where appropriate, for the supervision of a person who, on any particular occasion, administers a medicinal product under the protocol.
(5) Condition D is that when the medicine is supplied, there is in force in relation to it—
(a)an authorisation by the licensing authority on a temporary basis under regulation 174;
(b)before 1st January 2021, a marketing authorisation; or
(c)on and after 1st January 2021, a UK marketing authorisation [F3(including in Northern Ireland if supply is in accordance with regulation 167A)] or, in Northern Ireland, an EU marketing authorisation.]
F4(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
[F5(7) This regulation ceases to have effect on 1st April 2026.]
Textual Amendments
F1Reg. 247A inserted (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I. 2020/1125), regs. 1(2), 14 and reg. 247A inserted (N.I.) (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.R. 2020/349), regs. 1(2), 14
F2Reg. 247A(2) omitted (E.W.S.) (31.3.2024) by virtue of The Human Medicines (Amendments Relating to Coronavirus and Influenza) (England and Wales and Scotland) Regulations 2024 (S.I. 2024/344), regs. 1(2), 5(2) and (N.I.) (31.3.2024) by virtue of The Human Medicines (Amendments Relating to Coronavirus and Influenza) Regulations (Northern Ireland) 2024 (S.R. 2024/68), regs. 1(2), 5(2)
F3Words in reg. 247A(5)(c) inserted (1.1.2022) by The Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021 (S.I. 2021/1452), regs. 1(2), 22
F4Reg. 247A(6) omitted (E.W.S.) (31.3.2024) by virtue of The Human Medicines (Amendments Relating to Coronavirus and Influenza) (England and Wales and Scotland) Regulations 2024 (S.I. 2024/344), regs. 1(2), 5(3) and (N.I.) (31,3,2024) by The Human Medicines (Amendments Relating to Coronavirus and Influenza) Regulations (Northern Ireland) 2024 (S.R. 2024/68), regs. 1(2), 5(3)
F5Reg. 247A(7) inserted (E.W.S.) (31.3.2024) by The Human Medicines (Amendments Relating to Coronavirus and Influenza) (England and Wales and Scotland) Regulations 2024 (S.I. 2024/344), regs. 1(2), 5(4) and (N.I.) (31.3.2024) by The Human Medicines (Amendments Relating to Coronavirus and Influenza) Regulations (Northern Ireland) 2024 (S.R. 2024/68), regs. 1(2), 5(4)