# The Medicines for Human Use (Clinical Trials) Regulations 2004, Paragraph 6


Summaries of—
(a) any data submitted in support of the proposed modification or modifications; and
(b) any change to the summary assessment of the potential risks and benefits of using the product in the proposed trial.

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Source: https://www.legislation.gov.uk/uksi/2004/1031/schedule/3/part/3/paragraph/6 (the official version)
Page: https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/schedule-3/part-3/paragraph-6
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.