# The Human Medicines Regulations 2012, Regulation 76: Obligation in relation to product information

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

(1) The holder of a UK marketing authorisation or parallel import licence for a medicinal product must ensure that the product information relating to the product is kept up to date with current scientific knowledge.
(2) In this regulation “current scientific knowledge” includes the conclusions of the assessment and recommendations made public by means of—
(a) in the case of a medicinal product authorised for sale or supply by a UKMA(NI) or a UKMA(UK)(Category 2)—
(i) the European medicines web-portal established in accordance with Article 26 of Regulation (EC) No 726/2004, and
(ii) the UK web-portal established in accordance with regulation 203(1);
(b) in the case of a medicinal product authorised for sale or supply by a UKMA(GB) or a UKMA(UK)(Category 1), the UK web-portal established in accordance with regulation 203(1).

---
Source: https://www.legislation.gov.uk/uksi/2012/1916/regulation/76 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/regulation-76
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.