XVI.B.7. Quality systems for risk minimisation

Marketing authorisation holders and competent authorities should apply all their requirements for the quality management of pharmacovigilance systems, including the quality improvement cycle, the principles for good pharmacovigilance practices and the requirements for pharmacovigilance record management, (see GVP Module I) to all RMM-related processes and documents.

Marketing authorisation holders shall have specific quality system procedures and processes in place to ensure:

• Examination of options for risk minimisation and prevention [IR Art 11(1)(a)];
• Taking, by the marketing authorisation holder, of appropriate measures [IR Art 11(1)(a)]; and
• Effective communication with the competent authorities on new risks or changed risks, the risk management system and RMM [IR Art 11(1)(e)].

For this purpose, marketing authorisation holders should also:

• Establish and follow processes to ensure that RMM materials meet the quality requirements and are subject to version control (see XVI.B.4.1.);
• Establish and follow processes to ensure that the RMM are disseminated to healthcare professionals and patients according to the dissemination plan (see XVI.B.4.2.), and to keep records of the dissemination process and outcomes (e.g. records of receipt of RMM materials at healthcare sites);
• Establish and follow processes to ensure compliance, at the level of the marketing authorisation holder, with the tools of a risk minimisation control programme and to keep records thereof; and
• Follow the quality requirements for RMPs (see GVP Module V) and PASS (see GVP Module VIII).

A description of the process, data handling and records for the performance of continuous monitoring of the risk-benefit balance of the medicinal product, the monitoring result and the decision-making process for taking appropriate measures, and the monitoring of RMM outcomes shall be included in the pharmacovigilance system master file (PSMF) [IR Art 2(4)(a)-(b)], to be maintained by the marketing authorisation holder [DIR Art 104(3)(b)] (see GVP Module II).