CHAPTER VI

Risk management plans

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.
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)