# The Human Medicines Regulations 2012, Paragraph 21


Where an authorisation for the medicinal product to be placed on the market has been refused—
(a) in the case of a medicinal product for sale or supply in Northern Ireland, by a member State or by a country other than an EEA State, or
(b) in the case of a medicinal product for sale or supply in Great Britain, by a country other than the United Kingdom,
details of that decision and of the reasons for it.

---
Source: https://www.legislation.gov.uk/uksi/2012/1916/schedule/8/paragraph/21 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/schedule-8/paragraph-21
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.