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.

Summary of the risk management plan
Article 31
1
The summary of the risk management plan to be made publicly available in accordance with point (c) of Article 106 of Directive 2001/83/EC and Article 26(1)(c) of Regulation (EC) No 726/2004 shall include key elements of the risk management plan with a specific focus on risk minimisation activities and, with regard to the safety specification of the medicinal product concerned, important information on potential and identified risks as well as missing information.
2
Where a risk management plan concerns more than one medicinal product, a separate summary of the risk management plan shall be provided for each medicinal product.

Updates of the risk management plan
Article 32
1
Where the marketing authorisation holder updates a risk management plan, it shall submit the updated risk management plan to the national competent authorities or the Agency as appropriate. After agreement with the national competent authorities or the Agency as appropriate, the marketing authorisation holder may submit only the modules concerned by the update. If necessary, the marketing authorisation holder shall provide the competent authorities or the Agency with an updated summary of the risk management plan.
2
Each submission of the risk management plan shall have a distinct version number and shall be dated.

Format of the risk management plan
Article 33
The risk management plan shall be in the format set out in Annex I.
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)