# The Human Medicines Regulations 2012, Paragraph 29: Obligations as to post-authorisation safety studies


(1) The holder must submit in English—
(a) the study protocol; and
(b) the abstract of the final study report and the final study report.
(2) The holder must ensure that—
(a) all study information is handled and stored so as to allow for accurate reporting, interpretation and verification of that information;
(b) the confidentiality of the records of the study subjects remains protected; and
(c) the analytical dataset and statistical programmes used for generating the data included in the final study report are kept in electronic format and are available for auditing and inspection.
(3) The licensing authority may publish appropriate templates for the protocol, abstract and final study report.

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Source: https://www.legislation.gov.uk/uksi/2012/1916/schedule/12A/paragraph/29 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/schedule-12A/paragraph-29
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.