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The e-PIL pilot project – Changes in admission criteria

A year has now passed since the pilot project was launched. The project is again open for medicinal products that were on the market before the project start.

10.3.2022

March 1st marked the one-year anniversary of the ongoing e-PIL pilot project. On that occasion the framework of the project was reviewed in co-operation with the Ministry of Health. A decision was made to open the project up again for medicinal products that were on the market before the project started. All hospital products can as of now request admission. The project duration is three years. A request for participation shall be sent to the e-mail [email protected].

Project description

The scope of the project is to provide e-PILs only (the leaflets will be available online), instead of printed leaflets, for medicines used only in hospitals/healthcare facilities (i.e. medicines that have IMA‘s “H“ categorisation). The medicines must have an Icelandic marketing authorisation (approved via centralised, mutual recognition, decentralised, or national procedure) but do not have to be currently on the market in Iceland, although medicinal products will have to be put on the market in order to participate.

The e-PILs will be available online at www.serlyfjaskra.is

Project evaluation

A survey was conducted amongst the participating healthcare professionals at the beginning of the project and similar surveys will be repeated during and at the end of the project‘s run. The surveys include questions on the access, use and reading of e-PILs.

It was planned to conduct surveys amongst all participating pharmaceutical companies, both during the project and at the end. A decision has been made to conduct these surveys amongst the pharmaceutical companies that had been granted admission during the first year of the project (March 1st 2021- March 1st 2022). In these surveys, potential downsides of not having printed PILs will be evaluated

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