Pilot project on e-PILs - deadline extended
The deadline for participation for medicinal products already marketed has been extended till February 5th 2021.
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.