# The Human Medicines Regulations 2012, Paragraph 14


Where any clinical trials have been carried out outside the European Union, a statement to the effect that the trials met the ethical requirements of the Clinical Trials Directive.

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Source: https://www.legislation.gov.uk/uksi/2012/1916/schedule/8/paragraph/14 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/schedule-8/paragraph-14
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.