Welcome to Fimea’s e-submissions. The sections below present the matters in which you can act electronically in Fimea's electronic services. You can find more detailed instructions about the services under the titles of the respective services.
Login to the electronic services is done via Suomi.fi authentication from the top right corner of the page.
For example in pharmacy permits – you can view open pharmacy licences (open notices), closed applications and granted pharmacy licences without logging in to e-submissions. You can use e-submissions as a logged-in user in the following matters: applying for a pharmacy licence or submitting a notification of discontinuation of a pharmacy licence, applying for a special permit, reporting a suspected adverse reaction related to the use of a medicine, reporting operator and device information related to medical devices, submitting an operator to the NIS2 entity list or submitting shortage notifications.
Non-registered users can see open pharmacy licenses, the names of the persons who applied for a pharmacy licence and the granted pharmacy licenses in the electronic service for pharmacy licenses. Registered users can apply for a pharmacy license or submit a notification of waiving a pharmacy license in the service.
Electronic service for pharmacy licensesAdditional information
Instructions for using the service can be found for logged-in users under the Pharmacy Licenses tab at the top of the page.
Contact details related to the service: apteekit@fimea.fi
ERKKA is Fimea’s electronic service for applying for a special permit to dispense a medicinal product for consumption. In the service, it is possible to apply for patient-specific special permits for a person and unit-specific special permits for health care units. Similarly, it is also possible to apply for special permits for animal patient and veterinarian or veterinary clinic-specific permits.
Electronic service for special permitsAdditional information
Instructions for using the service can be found on Fimea’s website. (in Finnish and Swedish)
Contact details related to the service: ERITYISLUVAT@fimea.fi
You can use the electronic form to report a suspected adverse reaction to a veterinary medicinal product. The harm may have occurred in an animal or in a person exposed to a veterinary medicine. You can also report suspected environmental harm caused by a veterinary medicine.
Electronic service for reporting adverse reactions to a veterinary medicinal product (the form is available only in Finnish)Additional information
Instructions for using the service can be found on Fimea’s website.
Contact details related to the service: vethava@fimea.fi
You can report a suspected adverse reaction related to the use of a medicine in our e-submissions. There you can see a list of notifications you have previously submitted.
Electronic service for reporting adverse reactions (the form is available only in Finnish)Additional information
Instructions for using the service can be found on Fimea’s website.
Contact details related to the service: fimea.ev@fimea.fi
E-submissions for medical devices is intended for manufacturers of custom-made devices, excluding manufacturers of risk class III implantable devices, and for distributors who are required to submit a notification. In this service, it is possible to report your operator and device information as well as manage and view your reported data (submit notifications of changes and terminations).
E-submissions for medical devicesAdditional information
Instructions for using the service can be found on Fimea’s website.
Contact details related to the service: laiterekisteri@fimea.fi
The electronic service of the NIS2 entity list is used to report information on blood establishments and companies that supply medicinal products and medical devices that are supervised by Fimea, which is required by the Cyber Security Act. By logging in, you can select the authorization and conduct transactions in the service. You can log in either via the link below or from the top right corner of the page.
E-submissions for NIS2 entity listAdditional information
Instructions for using the service can be found on Fimea’s website.
Contact details related to the service: NIS2-CER@fimea.fi
The service can be used to submit shortage notifications and view and update a company’s own notifications. All current or future shortages reported to Fimea can also be viewed in the service.
Electronic service for shortage reportsAdditional information
Instructions for using the service can be found on Fimea’s website.
Contact details related to the service: saatavuushairioilmoitukset@fimea.fi