The Ministry of Health in collaboration with the Icelandic Medicines Agency (IMA) is running a pilot project on the introduction of e-PILs for hospital medicines.
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.
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, not by the patient.
The scope of the project is to provide e-PILs only, for medicines used only in hospitals/healthcare facilities, that is medicinal products that have IMA‘s “H“ categorisation. The medicines must have an Icelandic marketing authorisation (approved via centralised, mutual recognition, decentralised, or national procedure) and be on the market in Iceland in order to participate in the project.
All hospitals and health institutions have contacts for the project. These contacts will communicate about the project within their workplace.
For the participating medicinal productd e-PILs are available online only.
The product evaluation is carried out by the Ministry of Health.
- A survey was conducted amongst the participating healthcare professionals at the beginning of the project
- Similar surveys were repeated in September 2022 and will be conducted again at the end of the project.
The surveys include questions on the access, use and reading of e-PILs.
- A survey was conducted in September 2022 among Marketing Authorisation Holders that had submitted medicinal products in the first year of the project and it will be conducted again at the end of the project. These surveys assess problems which may arise and are related to the fact that a printed leaflet does not accompany the medicinal product.
- The IMA will investigate whether there has been an increase in the number of hospital products on the market during the project.
IMA publishes as list of participation products on its website called "Lyf í verkefni um rafræna fylgiseðla".
The IMA seeks participation of medicinal products to participate the e-PIL pilot project throughout the project‘s duration. A request for
participation shall be sent to the e-mail [email protected].
Facts about the e-PIL project
Yes. There is no need to remove a PIL in a foreign language, even if it does not perfectly match the Icelandic patient information. It is precisely the aim of the pilot project to direct healthcare professionals to the website www.serlyfjaskra.is where the Icelandic patient information is available.
No. The aim of the project is to the aim of the pilot project to direct healthcare professionals to the website www.serlyfjaskra.is where the Icelandic patient information is available.
No, it is only involves the printed PIL. Icelandic labelling should be on the packaging according to the Marketing Authorisation. It is possible to apply for a temporary exemption from labelling on packaging to prevent shortages and in special cases permanent exemptions can be approved. Such an application must be submitted to the Medicines Agency. Further information on the package labelling requirements can be found on our website.
No, only H-categorised hospital products can be included in the project.