The Icelandic Medicines Agency (IMA) calls for
candidates to participate in a pilot project on the use of electronic patient
information leaflets (e-PILs) for human medicinal products
participation of marketing authorisation holders (MAHs) for a pilot project on
implementation of e-PILs for medicinal products restricted to hospital use. The
project is supported by the Ministry of Health.
- 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
- 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
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.
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 product.
IMA will publish a
list of participating products on its website.