The e-PIL pilot project seeks to assess whether the introduction of electronic package leaflets (e-PILs) instead of printed labels with the view to ensure the safe use of hospital medicinal products and increase their availability. The project has been initiated by the Baltic state regulatory agencies in Latvia, Estonia and Lithuania and is intended exclusively for medicines designated for hospital use and administered solely by healthcare professionals.
It is anticipated that the project will take 2 years and results will be evaluated upon completion. The list of drugs covered by this project will be made available at the national regulatory agency websites.
Marketing authorization holders who are present or envisage entry to the markets of the Baltic states are invited to participate in the pilot project. However, a prerequisite is the presence of a valid marketing authorization and labelling on the packaging in Estonian, Latvian and / or Lithuanian. EPILs can be found in registers of medicinal products published by individual countries.
The coordination of multi language packaging is conducted by The Estonian State Agency of Medicines on behalf of other Baltic state agencies whereas monolingual packages will be coordinated at the country level. Information for marketing authorization holders regarding participation in this project is available on the website of the Estonian State Agency: https://ravimiamet.ee/en.