# The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025, Regulation 25: Amendment of regulation 44


In regulation 44(1) (interpretation), in the definition of “standard variation”—
(a) in sub-paragraph (o), at the end, omit “or”;
(b) in sub-paragraph (p), for “authorisation.” substitute “authorisation; or”;
(c) after sub-paragraph (p), insert—
“(q) a change to any packaging of the product, including the container or other form of packaging immediately in contact with the medicinal product, any packaging into which the container or other form of packaging immediately in contact with the product is placed, or to a leaflet that accompanies the product and contains information for the user of the product.”.

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Source: https://www.legislation.gov.uk/uksi/2025/317/regulation/25 (the official version)
Page: https://openlegislation.uk/medicines-products-for-human-use-fees-amendment-regulations-2025/regulation-25
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.