# The Human Medicines Regulations 2012, Regulation 3A: Preparation and assembly of medicinal products used for vaccination against an infectious disease or in the reformulation of such products

Extent: E+W+S+N.I.

(1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(3) Regulation 17(1) does not apply in circumstances where a medicinal product used under 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)—
(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—
...
“relevant arrangements” has the meaning given in regulation 19(4C) (exemptions from requirement for wholesale dealer’s licence).
(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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Source: https://www.legislation.gov.uk/uksi/2012/1916/regulation/3A (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/regulation-3A
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.