# The Human Medicines Regulations 2012, Paragraph 22


In the case of a medicinal product for sale or supply in Northern Ireland, a copy of any designation of the medicinal product as an orphan medicinal product under Regulation (EC) No. 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products together with a copy of the relevant Agency opinion.

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Source: https://www.legislation.gov.uk/uksi/2012/1916/schedule/8/paragraph/22 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/schedule-8/paragraph-22
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.