The Icelandic Medicines Agency (IMA) calls for candidates to
participate in the Ministry´s of Health pilot project on the use of electronic
patient information leaflets (e-PILs) for human medicinal products.
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“
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.
duration is three years.
For hospital products only
The project is solely intended for medicines restricted for
hospital use (“H” categorised) in accordance with the Icelandic marketing
authorisation. Administration must always be carried out by a healthcare
professional and may under no circumstances be carried out by the patient.
Aim of the project
The aim of the project is to evaluate whether the use of e-PILs
ensures safe medicinal treatments of patients. It will also be assessed whether
the project will lead to an increase of hospital products on the Icelandic
The concept of the project will be presented to the concerned
healthcare professionals and marketing authorisation holders before its
The e-PILs will be available online at www.serlyfjaskra.is
survey will be conducted amongst the participating healthcare
professionals (pharmacists/nurses/doctors) at the beginning, during and at
the end of the project‘s run. The survey will include questions on the
access, use and reading e-PILs.
survey will be conducted amongst participating pharmaceutical companies,
both at project start and end. There, potential downsides of not having
printed PILs during the project will be evaluated.
the project has ended, a review will be performed to assess whether the
availability of hospital medicinal products has increased on the Icelandic
A request for participation shall be sent to the e-mail [email protected]. For medicinal
products that are currently on the Icelandic market, a request shall be submitted
no later than February 5th 2021. Requests for participation for new
medicines can be submitted during the lifespan of the project.