# The Human Medicines Regulations 2012, Regulation 95: Offences in connection with application


A person is guilty of an offence if, in the course of an application for the grant, renewal or variation of a marketing authorisation for a relevant medicinal product, the person—
(a) fails to provide the licensing authority with any information that is relevant to the evaluation of the safety, quality or efficacy of the product; or
(b) provides to the licensing authority any information that is relevant to the evaluation of the safety, quality or efficacy of the product but that is false or misleading in a material particular;
(c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(d) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

---
Source: https://www.legislation.gov.uk/uksi/2012/1916/regulation/95 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/regulation-95
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.