# The Human Medicines Regulations 2012, Paragraph 25: Format of the risk management plan


The risk management plan must be in the following format—
(a) Part I: product overview;
(b) Part II: safety specification consisting of—
(i) Module SI: epidemiology of each indication and each target population,
(ii) Module SII: non-clinical part of the safety specification,
(iii) Module SIII: clinical trial exposure,
(iv) Module SIV: populations not studied in clinical trials,
(v) Module SV: post-authorisation experience,
(vi) Module SVI: additional EU requirements for the safety specification,
(vii) Module SVII: identified and potential risks, and
(viii) Module SVIII: summary of the safety concerns;
(c) Part III: pharmacovigilance plan, including post-authorisation safety studies;
(d) Part IV: plans for post-authorisation efficacy studies;
(e) Part V: risk minimisation measures, including evaluation of the effectiveness of risk minimisation activities;
(f) Part VI: summary of the risk management plan; and
(g) Part VII: annexes.

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Source: https://www.legislation.gov.uk/uksi/2012/1916/schedule/12A/paragraph/25 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/schedule-12A/paragraph-25
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.