# The Human Medicines Regulations 2012, Paragraph 7


If requested by the licensing authority, the risk management plan, together with a summary, that—
(a) describes the risk management system which the applicant will introduce for the medicinal product concerned; and
(b) shall be proportionate to the identified risks and the potential risks of the medicinal product, and the need for post-authorisation safety data.

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Source: https://www.legislation.gov.uk/uksi/2012/1916/schedule/8A/paragraph/7 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/schedule-8A/paragraph-7
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.