# The Human Medicines Regulations 2012, Regulation 205: Obligations on holders in relation to public announcements


(1) This regulation applies where the holder intends to make a public announcement relating to information on pharmacovigilance concerns in relation to the use of a medicinal product.
(2) The holder must inform the bodies listed in paragraph (3) where the product is subject to a UKMA(NI), UKMA(UK)(Category 2), THR(NI), THR(UK) or Article 126a authorisation, or the licensing authority where the product is subject to a UKMA(GB) , UKMA(UK)(Category 1) or THR(GB), of its intention to make the public announcement—
(a) as soon as is practicable once it forms that intention; and
(b) in any event no later than at the same time as, or before, the public announcement is made.
(3) The bodies listed in this paragraph are—
(a) the licensing authority;
(b) the EMA; and
(c) the European Commission.
(4) The holder must ensure that the information in the public announcement—
(a) is presented objectively; and
(b) is not misleading.

---
Source: https://www.legislation.gov.uk/uksi/2012/1916/regulation/205 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/regulation-205
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.