An "information package" which must accompany every single medicinal product authorized on European soil, to explain how it must be used and on what basis it must be prescribed.
European Industrial Pharmacists Group (EIPG) – Regulatory News
The European Medicines Agency (EMA) has published an action plan to improve product information (PI) for EU medicines, an information pack for patients and healthcare professionals that accompanies every single medicine authorized in the EU and explains how it should be used and prescribed.
One of the key areas of this plan is to explore how electronic or digital means can be used to improve the accessibility of medicines information for patients and healthcare professionals. EMA, together with the European Commission, will organize a multi-party workshop in the third quarter of 2018 to develop key principles for the use of electronic formats.
To ensure a comprehensive overview of all ongoing EU initiatives, at the workshop, EMA will launch a mapping exercise involving all stakeholders (patients and consumers, healthcare professionals, the pharmaceutical industry and national competent authorities). To facilitate this mapping exercise, interested parties are invited to submit an overview of electronic/digital formats initiatives for product information they are aware of or work on. Further information is available on the EMA website.
