Frequently asked questions about reporting shortages

No. The company must enter the current and future shortages reported before 31 May 2023 in the e-service. No fee will be charged for previously notified shortage notifications when they are entered into the service by 13 June 2023 at 23:59.

The e-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.

The e-service 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. Logging in to the service is not possible for other actors, such as retail distributors.

At first, the service will only be available to companies with a Finnish business ID.

Suomi.fi e-Identification is used in logging in to the service. You can log in using the login methods of Suomi.fi’s Finnish operators, and using the service is possible for persons with a Finnish personal identity code.

The authorisation is made in the Suomi.fi e-Authorizations service for a person who has a Finnish personal identity code.  The person granting the authorisation must have 

• a Finnish personal identity code and online banking codes, mobile certificate or certificate card
• Alternatively, a valid and confirmed foreigner's identifier (UID), the Finnish Authenticator application in use, or a valid right to grant an authorization or a representative's right to grant an authorization.

Instructions for granting Suomi.fi e-Authorization for reporting shortages (pdf)

Fimea has added the companies which reported shortage notifications in 2022 as service users. If your company has not submitted notifications during that period, you must submit a request to Fimea to add the company as a service user. The company's name, business ID and invoicing information must be included in the request. Send the request to [email protected].

The notifications must be submitted through the e-service. 

Foreign operators who do not have a business ID and who can not obtain a Suomi.fi e-Authorization can submit the notifications only in PDF format until the service can also be used by foreign operators.

It is not possible to update shortage notifications submitted to the electronic services using a PDF form. The substitute should be able to log in to the service.

Yes. In the service, it is possible to report a shortage for all packages that have been notified as on the market. You can search for the package with the vnr number or product name if the package does not have a vnr number.

No. The package selection shows all packages stored in Fimea’s Register for Medicinal Products, so make sure to select the correct marketing authorisation holder's package.

Yes. The front page view shows all company notifications, and anyone acting on behalf of the company can edit or cancel the notification using the Edit feature.

Yes. On the other hand, a non-public provider of additional information for Fimea's requests should be a designated person.

A shortage that has already begun cannot be cancelled. The final date for cancellation is the day before the marked start date of the shortage. In this case, the shortage can be marked as ended by editing the end date of the shortage.

Not all reported data can be edited. The editing function allows you to change the duration of the shortage, the providers of additional information and the details of the next batch of pharmaceuticals.

In regard to shortages, Fimea's shortage search publishes the product, the duration of the shortage and public providers of additional information no earlier than two weeks before the start of the shortage. In addition, the product and the duration of the shortage are published as open data.

The notifications are published the day after receiving them via the e-service.

An invoice for a shortage notification is sent to the company on whose behalf the e-service is used. The invoicing information is maintained by Fimea's financial unit and the changed invoicing information must be notified to [email protected].

Yes. A processing fee is charged for shortage notifications in accordance with the Decree on fees, including cancelled notifications. The reporting of shortages in veterinary medicinal products and parallel distribution medicinal products is voluntary under the legislation in force, so no fee is charged for their shortage notifications.