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Regulation 3A Preparation and assembly of medicinal products used for vaccination against an infectious disease or in the reformulation of such productsF1F8

United Kingdom

F2(1)

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F3(2)

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(3)

Regulation 17(1) does not apply in circumstances where a medicinal product used F4under relevant arrangements for vaccination against an infectious disease is labelled by a holder of a wholesale dealer’s licence to take account of a change to the shelf life of the product because of the thawing of the product.

(4)

Chapter 1 of Part 13 (requirements for packaging and package leaflets relating to medicinal products)—

F5(a)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(b)

is to be construed as permitting labelling in accordance with paragraph (3), in the case of a product which is otherwise labelled in accordance with that Part.

(5)

For the purposes of this regulation—

  • F6...

  • “relevant arrangements” has the meaning given in regulation 19(4C) (exemptions from requirement for wholesale dealer’s licence).

F7(6)

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Annotations

Textual amendments

F1

Reg. 3A inserted (19.12.2020) by The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (S.I. 2020/1594), regs. 1(2), 4 and The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (S.R. 2020/350), regs. 1(2), 4

F2

Reg. 3A(1) omitted (31.3.2026) by virtue of The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 4(3)

F3

Reg. 3A(2) omitted (31.3.2026) by virtue of The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 4(3)

F4

Words in reg. 3A(3) substituted (31.3.2026) by The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 4(4)

F5

Reg. 3A(4)(a) omitted (31.3.2026) by virtue of The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 4(5)

F6

Words in reg. 3A(5) omitted (31.3.2026) by virtue of The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 4(6)

F7

Reg. 3A(6) omitted (31.3.2026) by virtue of The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 4(7)

F8

Words in reg. 3A heading substituted (31.3.2026) by The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 4(2)