Pilot project on e-PILs – deadline extended

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.

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.
  • Project
    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
market.

Project plan

The concept of the project will be presented to the concerned
healthcare professionals and marketing authorisation holders before its
initiation.

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

Project evaluation


  • A
    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.
  • A
    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.
  • After
    the project has ended, a review will be performed to assess whether the
    availability of hospital medicinal products has increased on the Icelandic
    market.

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. 

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