Each safety concern needs to be individually considered and the selection of the most suitable risk minimisation measure should take into account the seriousness of the potential adverse reaction(s) and its severity (impact on patient), its preventability or the clinical actions required to mitigate the risk, the indication, the route of administration, the target population and the healthcare set. [...] Risk minimisation measures should therefore guide optimal use of a medicinal product in clinical practice with the goal of supporting the provision of the right medicine, at the right dose, at the right time, to the right patient and with the right information and monitoring. [...] The performance of these measures in healthcare systems requires assessment to ensure that their objectives are fulfilled and that the measures in place are proportionate taking account of the risk-benefit balance of the product and the efforts required of healthcare professionals and patients to implement the measures. [...] The nature of the safety concern in the context of the risk-benefit balance of the product, the therapeutic need for the product, the target population and the required clinical actions for risk minimisation are factors to be considered when selecting risk minimisation tools and developing an implementation strategy to accomplish the desired public health outcome. [...] Competent authorities in Member States The national competent authorities are responsible for the oversight at national level of the implementation of additional risk minimisation measures imposed as a condition of the marketing authorisation for the safe and effective use of a medicinal product in the EU, irrespective of the route of marketing authorisation.
Authors
Related Organizations
- Pages
- 23
- Published in
- Malta
Table of Contents
- Table of contents 3
- XVI.A. Introduction ..................................................................................... 4 3
- XVI.B. Structures and processes ................................................................. 5 3
- XVI.C. Operation of the EU network .......................................................... 15 3
- XVI. Appendix 1. Key elements of survey methodology ............................. 21 3
- XVI.A. Introduction 4
- XVI.B. Structures and processes 5
- XVI.B.1. General principles 5
- XVI.B.2. Risk minimisation measures 6
- XVI.B.2.1. Educational programme 6
- XVI.B.2.1.1. Educational tools 7
- XVI.B.2.2. Controlled access programme 8
- XVI.B.2.3. Other risk minimisation measures 9
- XVI.B.2.3.1. Controlled distribution system 9
- XVI.B.2.3.2 Pregnancy prevention programme 9
- XVI.B.2.3.3. Direct health care professional communication DHPC 10
- XVI.B.3. Implementation of risk minimisation measures 10
- XVI.B.4. Effectiveness of risk minimisation measures 11
- XVI.B.4.1. Process indicators 12
- XVI.B.4.2. Outcome indicators 13
- XVI.B.5. Coordination 14
- XVI.B.6. Quality systems of risk minimisation measures 14
- XVI.C. Operation of the EU network 15
- XVI.C.1. Roles and responsibilities within the EU regulatory network 15
- XVI.C.1.1. The European Medicines Agency 16
- XVI.C.1.2. The Pharmacovigilance Risk Assessment Committee PRAC 16
- XVI.C.1.3. Competent authorities in Member States 16
- XVI.C.2. Roles and responsibilities of the marketing authorisation holder or applicant in the EU 17
- XVI.C.3. Healthcare professionals and patients 18
- XVI.C.4. Impact of risk minimisation measures effectiveness on RMPPSUR in the EU 18
- XVI.C.5. Transparency 19
- XVI. Appendix 1. Key elements of survey methodology 21
- XVI.App1.1. Sampling procedures and recruitment strategy 21
- XVI.App1.2. Design and administration of the data collection instruments 22
- XVI.App1.3. Analytical approaches 22
- XVI.App1.4. Ethics privacy and overall study feasibility 23
