The e-PIL pilot project – Changes in admission criteria

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

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

Last updated: March 10, 2022
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