# The Human Medicines Regulations 2012, Paragraph 4: Variations leading to the revision of product information


Where a variation leads to the revision of the summary of product characteristics, labelling or the package leaflet, the revision must be considered by the licensing authority as part of that variation.

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Source: https://www.legislation.gov.uk/uksi/2012/1916/schedule/10A/paragraph/4 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/schedule-10A/paragraph-4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.