# The Human Medicines Regulations 2012, Paragraph 20


Where , in the case of a medicinal product for sale or supply in Northern Ireland, an authorisation for the medicinal product to be placed on the market has been granted by a member State in accordance with the 2001 Directive, a copy of—
(a) the summary of the product characteristics approved by the competent authority of the member State; and
(b) the package leaflet approved by that competent authority.

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Source: https://www.legislation.gov.uk/uksi/2012/1916/schedule/8/paragraph/20 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/schedule-8/paragraph-20
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.