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Changes to the shortage notification fees payable by marketing authorisation holders and to the notification form as from 1 September 2022
With the new decree on fees chargeable by the Finnish Medicines Agency, there will be changes to the shortage notification fees payable by marketing authorisation holders. The notification forms have also been simplified and Fimea no longer requires the same amount of additional information as before. In the future, all information will be supplied as part of the first shortage notification.
The fees specified in the new decree on fees chargeable by Fimea will apply as from 1 September 2022
The Ministry of Social Affairs and Health has issued a decree on the fees chargeable under public law by the Finnish Medicines Agency Fimea. The new decree (798/2022) entered into force on 1 September 2022, and the fees for shortage notifications submitted as from1 September 2022 will be charged in accordance with the new decree.
Under the new decree, the same fee will always be charged for the first shortage notification. A marketing authorisation holder can apply for an exemption from the fee if there are justified reasons for doing so. Under the decree, the exemption can be granted on the grounds of a shortage caused by a pandemic, natural disaster, shortages of competing products and an extensive recall arising from a decision made by the authorities.
All information will be submitted on a single form
Based on feedback from operators, reporting shortages has been simplified by reducing the amount of information required and combining the information and additional information published on the notification into a single form.
The marketing authorisation holder must submit the following information on the revised notification form:
- details of the shortage (public information for the online service)
- additional information for the authorities (partially confidential).
The form also contains a space for the notification fee and invoicing details as well as instructions for completing the form.
In the future, all information will be submitted as part of the first shortage notification. The marketing authorisation holder no longer needs to submit the additional information as part of the update or cancellation notification.
Shortages affecting specific products and package sizes can still be reported on a pdf form or an excel form on which the details of more than one product can be entered. As in the past, the notifications must be sent to Fimea by secure email.
The details of the shortages are published on the shortages search on Fimea’s website, which is open to all.
As the information entered on the shortage notification form is machine read, it is important that the instructions for completing the form are followed. This ensures that the information is displayed correctly in the shortage search.
Introducing the new form
The new notification form will be introduced as soon as the decree on fees chargeable by Fimea has entered into force. Pharmaceutical operators are therefore requested to report shortages on the new form as from 1 September 2022.
Shortage notification and instructions form (pdf)
Shortage notification and instructions form (excel)
Fimea News 1 September 2022:
The new decree on fees chargeable by the Finnish Medicines Agency entering into force on 1 September 2022
For inquiries, please contact:
Information entered on the forms:
Johanna Linnolahti, Head of Section, tel. +358 29 522 3231
Päivi Luhtanen, Senior Inspector, tel. +358 29 522 3263
Satu Suvanto, Senior Pharmaceutical Inspector, tel. +358 29 522 3250
Forms and their receipt:
Registry office, tel. +358 29 522 3602
Email address format: firstname.lastname@fimea.fi