Project
afgesloten

PILS-BOX: Study on the feasibility and the value added of a possible "summary information box" in the package leaflets and the summaries of product characteristics of medicinal products for human use (‘PIL-S BOX’)

In 2008 the European Union adopted legislative proposals on medicines one of which referred to the introduction of new sections in the PIL and SmPC on ‘key information'. So far, adding such section is no common practice in the EU.
The objective of this study is to provide the European Commission with an assessment of:
- the potential effects of the introduction of "key information" sections to identify key safety messages balanced with information on the benefit of medicines in patient information leaflets (PIL) and Summaries of Product Characteristics (SmPC) and the feasibility of such a tool in the context of the European Union legislation
The project includes a combination of a systematic literature review and stakeholder consultation via online structured questionnaires.
A report that provides the European Commission with information on the value of adding a key information section to the PIL and SmPC.
Funding
DG Sanco
In this project we work together with
University of Leeds, School of Healthcare (prof. Theo Raynor)