# The Human Medicines Regulations 2012, Paragraph 13: Pandemic situation with respect to human influenza


(1) By way of exception to the provisions of this Schedule, where a pandemic situation with respect to human influenza is duly recognised by the World Health Organisation, or the licensing authority, the licensing authority may exceptionally and temporarily accept a variation to the terms of a UK marketing authorisation for a human influenza vaccine, where certain non-clinical or clinical data are missing.
(2) Where a variation is accepted pursuant to sub-paragraph (1), the holder must submit the missing non-clinical and clinical data within a time limit set by the licensing authority.

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Source: https://www.legislation.gov.uk/uksi/2012/1916/schedule/10A/paragraph/13 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/schedule-10A/paragraph-13
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.