V.C.3. Assessment of the risk management plan within the EU regulatory network

Within the EU, the regulatory oversight of RMPs for medicinal products authorised centrally lies with the Pharmacovigilance Risk Assessment Committee (PRAC). For the RMP assessment, the PRAC appoints a PRAC rapporteur who works closely with the (Co-)Rapporteur(s) appointed by the CHMP and Committee for Advanced Therapies (CAT) (for ATMPs) or with the Reference Member State, as appropriate. The EMA may, on a case-by-case basis, consult healthcare professionals and patients during the assessment of RMPs to gather their input on proposed risk minimisation measures.

For medicinal products authorised nationally, the national competent authorities are responsible of the assessment of the RMP. The national competent authority may impose an obligation on a marketing authorisation holder to operate a risk management system for each medicinal product, as referred to in DIR Art 104(3)(c), if there are concerns about the risks affecting the risk-benefit balance of an authorised medicinal product. In that context, the national competent authority shall also oblige the marketing authorisation holder to submit a detailed description of the risk-management system which he intends to introduce for the medicinal product concerned [DIR Art 104a(2)].

For centrally authorised medicinal products, only risk minimisation measures recommended by the PRAC and subsequently agreed by the CHMP should be included in the risk minimisation plan as additional risk minimisation activities. Additional risk minimisation measures are conditions to the marketing authorisation; key elements are detailed in annex II to the Commission decision. In addition, exceptionally, certain conditions or restrictions with regard to the safe and effective use of the medicinal product may be imposed to the Member States through a Commission decision in accordance with DIR Art 127a for their implementation at national level.

When necessary, the competent authorities should ensure that all marketing authorisation holders of medicinal products containing the same active substance make similar changes to their risk minimisation measures when changes are made to those of the reference medicinal product.