# The Human Medicines Regulations 2012, Regulation 96: Provision of false or misleading information

Extent: E+W+S+N.I.

(1) The holder of a marketing authorisation or parallel import licence is guilty of an offence if the holder provides any information to which paragraph (2) applies that is relevant to the evaluation of the safety, quality or efficacy of a medicinal product but that is false or misleading in a material particular to—
(a) the licensing authority;
(b) the EMA; or
(c) the competent authorities of other EEA States.
(2) This paragraph applies to information about the product that is supplied pursuant to the obligations in—
(a) these Regulations; or
(b) Regulation (EC) No 726/2004.
(3) This regulation is without prejudice to the operation of regulation 95.

---
Source: https://www.legislation.gov.uk/uksi/2012/1916/regulation/96 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/regulation-96
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.