Icelandic Medicines Agency
Electronic package leaflets
R merki rafrænna fylgiseðla
Heilbrigðisráðuneytið stendur fyrir tilraunaverkefni um innleiðingu rafrænna fylgiseðla fyrir H-merkt lyf.
Project description
The project involves using electronic patient information instead of a paper package leaflet and is limited to medicines used in healthcare institutions, namely H-labelled medicines.
The medicine does not need to have been marketed previously.
The project began on 1 March 2021 and was originally intended to run for four years.
The Ministry of Health is responsible for evaluating the project.
H-labelled medicines
The project is limited to medicines used in hospitals (H-labelled medicines) in accordance with their marketing authorisation and registration in Iceland. Under no circumstances may the medicine be supplied directly to a patient for personal use. It is an absolute requirement that a healthcare professional administers the medicine.
Objectives of the pilot project
The project aims to assess whether the use of electronic patient information adequately ensures safe treatment with medicines for patients. It will also examine whether the use of electronic patient information leads to an increase in the number of H-labelled medicines on the market.
Project organisation
The Ministry of Health has designated contacts at all hospitals/healthcare institutions. These contacts will be responsible for communicating information about the project within their institutions.
Electronic patient information is available in Medicinal Product Information.
Project evaluation
A survey was conducted among the healthcare professionals concerned at the beginning and midway through the project. A survey will also be conducted at the end of the project. These surveys assess access to electronic patient information, as well as its use and readership.
A survey was conducted midway through the project among pharmaceutical companies admitted during its first year, and a further survey will be conducted at the end of the project. These surveys assess any shortcomings that may arise from the absence of a printed package leaflet with the medicine.
The Icelandic Medicines Agency (IMA) will examine whether the number of H-labelled medicines on the market has increased.
Applications for H-labelled medicines will be accepted throughout the project. Applications to participate in the project must be sent to e-PIL@lyfjastofnun.is.
The application must include:
the name of the medicine
information on the active substances
strength
pack size
pharmaceutical form
the name of the company’s contact person for the project.
IMA has published a list of medicines included in the project on its website.
FAQ on the electronic patient information pilot project
1. May a package leaflet in a foreign language be included in the packaging?
Yes. There is no need to remove a foreign-language package leaflet, even if it does not fully correspond to the Icelandic version. Directing healthcare professionals to the website where the Icelandic Summary of Product Characteristics (SmPC) and package leaflet can be found is part of the pilot project.
2. Should there be a QR code on the packaging that can be scanned to access the Icelandic product information?
No. The project involves directing healthcare professionals to IMA’s website, serlyfjaskra.is, where Icelandic product information is available.
3. Does the pilot project allow Icelandic labelling to be omitted from the packaging?
No, the project only concerns the package leaflet. Icelandic labelling must still appear on the packaging. Please note that a temporary exemption from packaging labelling requirements can be requested from IMA to prevent shortages. In special cases, an indefinite exemption can be requested, as set out in the guidelines.
4. Can medicines that are not H-labelled be included in the project, such as medicines normally administered by healthcare professionals?
No, only H-labelled medicines can be included in the project. Staff at healthcare institutions/hospitals will be informed about which medicines are included. Other medicines normally administered by healthcare professionals may be administered outside the healthcare institutions/hospitals concerned.
5. Can a medicine be included in the project if there is a QR code on the packaging?
Yes, a QR code is not an obstacle. Healthcare professionals will be encouraged to read and direct others to package leaflets on serlyfjaskra.is, IMA’s website.
The pilot project is still in effect even though the stated timelines have passed.