# The Human Medicines Regulations 2012, Regulation 56: Applications containing information supplied in relation to another product with consent


(1) This regulation applies to an application for a UK marketing authorisation for a relevant medicinal product where—
(a) the product that is the subject of the application (“product A”) has the same qualitative and quantitative composition in terms of active substances and the same pharmaceutical form as a product (“product B”);
(b) product B is the subject of a UK marketing authorisation; and
(c) the holder of the marketing authorisation for product B has allowed use to be made of the pharmaceutical, pre-clinical and clinical documentation contained in the file on product B with a view to examining subsequent applications relating to other medicinal products possessing the same qualitative and quantitative composition in terms of active substances and the same pharmaceutical form.
(2) The documentation referred to in paragraph (1)(c) in relation to product B may be used in relation to the application in relation to product A ...

---
Source: https://www.legislation.gov.uk/uksi/2012/1916/regulation/56 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/regulation-56
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.