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
- 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.
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
- 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 before February 1st
2021. Requests for participation for new medicines can be submitted during
the lifespan of the project.
Request for participation shall contain the
following information: Product name, active ingredients(s), strength(s),
pharmaceutical form(s) and package size(s) and a contact person for the
IMA will publish a list of participating
products on its website.