PART 12U.K.Dealings with medicinal products

Modifications etc. (not altering text)

CHAPTER 3U.K.Exemptions

Other exemptionsU.K.

[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