V.B.2. Responsibilities for risk management

The principal organisations directly involved in medicinal products’ risk management planning are applicants/marketing authorisation holders and the competent authorities who regulate the medicinal products.

An applicant/marketing authorisation holder is responsible for:

• having an appropriate risk management system in place [DIR 8(3)(iaa); DIR Art 104(3)(c)];
• ensuring that the knowledge and understanding on the product’s safety profile, following its use in clinical practice, are critically reviewed. The marketing authorisation holder should monitor pharmacovigilance data to determine whether there are new risks or whether risks have changed or whether there are changes to the risk-benefit balance of medicinal products [Dir Art 104(3)(e)], and update the risk management system and the RMP accordingly, as described below. The critical review of the safety profile of the product is a continuous activity and is reflected in data submitted with periodic safety update reports (PSUR) (see GVP Module VII), where an RMP submission may or may not be warranted. In addition, there are two specific milestones when the marketing authorisation holders of products approved following full initial marketing authorisation applications are advised to reflect on the need to review the list of safety concerns and the planned and ongoing pharmacovigilance and risk minimisation activities:
  • with the (first) 5-year renewal;
  • in the time period when the first PSUR following the first 5 year renewal is due for submission. It is anticipated that this PSUR submission would occur approximately 8-9 years following the granting of the marketing authorisation, at the time when the assessment of the initial marketing authorisation applications for generic products for the active substance commences. As such, the safety profile of the medicinal product is likely to be sufficiently well characterised to allow for a critical review and update of the list of safety concerns.