# The Human Medicines Regulations 2012, Paragraph 39


The licence holder must inform the licensing authority immediately of any matter coming to the licence holder's attention which might reasonably cause the licensing authority to believe that a special medicinal product or EAMS medicinal product imported in accordance with this paragraph can no longer be regarded as a product which can safely be administered to human beings or as a product which is of satisfactory quality for such administration.

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Source: https://www.legislation.gov.uk/uksi/2012/1916/schedule/4/paragraph/39 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/schedule-4/paragraph-39
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.