Italy: European Medicines Agency trials the package leaflet 2.0

In brief

In July 2023 the European Medicines Agency (EMA), together with the network of the Heads of Medicines Agencies (HMAs) and the European Commission, started to work to in order to enable the use of the electronic product information (ePI), so called package leaflet 2.0.


Key takeaways

The package leaflet 2.0 consists of an electronic card that provides access to the information contained therein to the various telemedicine platforms; within that, the mandatory information on medicinal products, including the description of the product characteristics and the label, adapted for the electronic management, will be available.

The use of package leaflet 2.0 will improve the accessibility of information and speed up the process of updating the package leaflet and the label. Indeed, the contents will be available in several languages and will be editable quickly.

At first, the information contained will be a transposition of what is already available in printed package leaflets or in pdf format on the websites of companies and regulatory authorities. However, EMA's purpose is to provide further data, such as multimedia content, notification tools and reports on possible adverse reactions associated with specific active substances.

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