# The Human Medicines Regulations 2012, Paragraph 19


Where an authorisation for the medicinal product to be placed on the market has been granted by , in the case of a medicinal product for sale or supply in Northern Ireland, a member State or by a country other than an EEA State, or in the case of a medicinal product for sale or supply in Great Britain, by a country other than the United Kingdom or by the European Commission—
(a) a copy of that authorisation;
(b) a summary of the safety data, including the data contained in the periodic safety update reports, where available; and
(c) any suspected adverse reaction reports.

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Source: https://www.legislation.gov.uk/uksi/2012/1916/schedule/8/paragraph/19 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/schedule-8/paragraph-19
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.