The European Medicines Agency Communication
The European Commission has published its report to the European Parliament and the Council on current shortcomings in the Summary of Product Characteristics (SmPC) and the package leaflet (PL) and how they could be improved in order to better meet the needs of patients and healthcare professionals.
The Commission engaged external contractors to produce two studies in order to provide supporting information for this report:
- Study on the PL and the SmPC for Human use to:
- Assess the readability and comprehensibility of the SmPC and the PL as sources of information on prescription and non-prescription medicines for patients and healthcare professionals;
- Assess the causes and (potential) consequences of identified shortcomings;
- Recommend improvement of the SmPC and the PL of prescription and non-prescription medicines based on this assessment.
- Study on the feasibility and the value of a possible ‘key information section’ in patient information leaflets and SmPC of medicinal products for human use (‘PILS-BOX Study’) to:
- Collect existing evidence on the potential impact of adding a key information section on the safety and efficacy of medicines’ use;
- Assess the feasibility of adding a key information section in the context of the EU legislation;
- Assess the potential cost/efficacy of adding key information in the context of the EU legislation.
The full report is available by clicking here.