One of the many challenges faced by 7 million Ukrainian’s refugees now in the EU is accessing up-to-date information about prescription medicines in their own language. Product information on prescription medicines is currently only available to patients in the language of the country in which the medicine is dispensed, via the mandatory product information leaflet. This puts patients who do not understand this language at risk when they need to take medicines.
To help address this need, EFPIA and Member companies* with the support of technology provider GS1** are launching a technical solution allowing the Ukrainian patients displaced in the EU a rapid, direct, and free of charge access via their mobile phone to essential product information on prescription medicines, in their native language.
With Poland welcoming the largest number of Ukrainian refugees, the project will be launched in this country in September, 2022. An intention to further EU member States will be considered upon the evaluation of the initiative.
How does it work?
Every pack of medicines in the EU has a unique datamatrix code printed on the packaging. Using a free, dedicated app, clinicians or patients can scan the datamatrix code on the medicines packaging and access the electronic Product Information Leaflet (e-PIL) in Ukrainian. These e-PILs are a faithful translation of the official PIL available in paper format for each medicine. For patients, clinicians or other groups wanting to access the service please go to the following links:
App Store link to download the application.
Play Store link to download the application.
When Ukrainian is set as default language of the device the app interface will automatically display in Ukrainian.
The electronic Product Information Leaflet (e-PIL) is an electronic version of the Product Information Leaflet (PIL) contained in every medicine package which has been approved by the competent authorities in line with EU regulation. The PIL is printed in the language of the country where it is dispensed and contains key basic and important information on the respective medicine. The e-PIL is a digitally available Ukrainian translation of the official PIL usually available in paper in the box.
Access to the e-PIL in Ukrainian requires downloading and installing an App on a smartphone running on either Android or iOS. By scanning the data matrix code on the package (box or vial) of a medicine with this app, the user will access the corresponding e-PIL in Ukrainian.
The following companies have volunteered to be part of the initiative: Astellas, Bayer, Boehringer Ingelheim, Chiesi, Gilead, Johnson & Johnson, Lundbeck, Novo Nordisk, Merck, Roche, Sanofi, Pfizer (list of companies will be updated).
The e-PIL is a voluntary and temporary initiative. Depending on their ability, companies involved will not necessarily provide a Ukrainian e-PIL for their entire portfolio and may make a selection of most-widely used products.
The initiative is open for new members (companies) to join and is not limited to EFPIA members.
We are aiming to have first e-PILs available in Ukrainian in September 2022. However, the number of translations might be limited at the start and will gradually increase up until the end of the year. The initiative is temporary and is not meant to be continued after the end of the invasion.
Although our aim is to make Ukrainian e-PIls available for as many products as possible, the initiative is a voluntary one and unfortunately does not cover all medicines on the market. If you could not access a translation, your product may fall in one of these situations:
- Your product is not a prescription-only medicine. For technical reasons, the app only covers prescription-only products
- The company marketing your product has not chosen to be part of this voluntary initiative.
- The company marketing your product is part of the initiative, but the translation is still pending. Companies are working to increase the number of translations available to patients.
At the first stage of e-PIL implementation, it will be available only in Poland where the largest number of Ukrainian refugees have settled. We will consider extension to other EU member states based on evaluation of the results of the first stage.
The initiative is based on the Datamatrix system already in place to prevent counterfeited medicines from entering the supply chain. The Datamatrix code is only available on prescription medicines.
The electronic document made available through the App is a faithful translation of the Product Information Leaflet. It is the responsibility of the marketing authorization holder to provide accurate information.
For companies or national associations wanting information on partnering in the service please contact: e-PIL_UA@efpia.eu
* Astellas, Bayer, Boehringer Ingelheim, Chiesi, Gilead, Johnson & Johnson, Novo Nordisk, Lundbeck, Merck, Pfizer, Roche, TEVA. The list of participants will be updated.
** GS1 is a key partner of the project. Read more about their contribution here.