Paragraph 25 Format of the risk management planF1

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.

Annotations

F1: Sch. 12A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 6 (as amended by S.I. 2019/1385, reg. 1, Sch. 1 para. 9 and S.I. 2020/1488, reg. 1, Sch. 2 para. 192); 2020 c. 1, Sch. 5 para. 1(1)