The Human Medicines Regulations 2012

[F1Protocols relating to coronavirus and influenza vaccinations and immunisationsU.K.
This section has no associated Explanatory Memorandum

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