E-service for reporting shortages is coming along

The Finnish Medicines Agency Fimea is developing an e-service for reporting shortages of medicinal products. The current method of submitting shortage notifications as PDF or Excel files will be phased out with the introduction of the new service.

The aim is to introduce the service at the turn of May and June, or if the development timetable is delayed, in early autumn 2023. The schedule will be specified as the project progresses.

Before the system is introduced, there will be a period during which operators will be able to add old shortage notifications in addition to entering new notifications in the e-service. No fee will be charged for previously submitted shortage notifications that are entered during this period.

More information on the timetable and next steps will be provided closer to the introduction.

Shortage notifications will be published on the Fimea website in the future as well.

New service improves the quality of shortage information

In addition to submitting notifications, the e-service will allow operators to monitor the status of their notifications and make it easier to update notifications. The data in Fimea’s register for medicinal products will be combined with the e-service, which will reduce the possibility of errors when submitting a notification. This will make shortage information more cohesive and usable.

Using the service requires a Suomi.fi company authorisation

The e-service for reporting shortages is intended for marketing authorisation holders or registration holders and their representatives as well as parallel importers and distributors, i.e., companies submitting shortage notifications. Using the service requires a Finnish business ID.

Electronic identification to the e-service is not yet possible for foreign companies, so notification submissions from foreign operators will continue with PDF-form files until the service can also be introduced for foreign companies.

Representatives will use Suomi.fi e-Identification to identify themselves in the e-service. Using the e-service for reporting shortages will be possible once a person is authorised to act on behalf of a company in the Suomi.fi e-Authorizations service. Companies can already prepare for the introduction of the e-service by creating mandates for shortage matters for the necessary persons. Mandates are granted in the Suomi.fi e-Authorizations service.

 

Read more:

Guideline: Granting Suomi.fi e-Authorization for reporting shortages