CHAPTER VI

Risk management plans

Content of the risk management plan
Article 30
1
The risk management plan established by the marketing authorisation holder shall contain the following elements:
a
an identification or characterisation of the safety profile of the medicinal product(s) concerned;
b
an indication of how to characterise further the safety profile of the medicinal product(s) concerned;
c
a documentation of measures to prevent or minimise the risks associated with the medicinal product, including an assessment of the effectiveness of those interventions;
d
a documentation of post-authorisation obligations that have been imposed as a condition of the marketing authorisation.
2
Products containing the same active substance and belonging to the same marketing authorisation holder may be subject, where appropriate, to the same risk management plan.
3
Where a risk management plan refers to post-authorisation studies, it shall indicate whether those studies are initiated, managed or financed by the marketing authorisation holder voluntarily or pursuant to obligations imposed by the national competent authorities, the Agency or the Commission. All post-authorisation obligations shall be listed in the summary of the risk management plan together with a timeframe.
Regulation revoked in part (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 9 para. 1(t) (subject to transitional provisions in S.I. 2012/1916, Sch. 33A); 2020 c. 1, Sch. 5 para. 1(1)