E-service for reporting shortages becomes active
Fimea's online service for reporting shortages in medicinal products will be made available for pharmaceutical companies on Wednesday 31 May 2023. From now on, pharmaceutical companies operating in Finland will report shortages via the e-service. Foreign companies will continue to submit shortage notifications to Fimea with a PDF form for the time being.
After 31 May 2023, pharmaceutical companies using the e-service will have two weeks to add previously made notifications for current and future shortages in the e-service free of charge. A handling fee will be charged for completely new notifications submitted during this period, in accordance with the decree on fees chargeable by the Finnish Medicines Agency. Starting from 14 June 2023 at 00:00, a fee will be charged for all shortage notifications submitted in the e-service. Shortage notifications of parallel distribution and veterinary medicinal products will be processed free of charge.
The e-service uses Suomi.fi e-Identification for logging in, and the user must have a Finnish personal identity code. In addition, the user of the e-service needs to be granted a Suomi.fi e-Authorization to act on behalf of a company. The e-Authorization can also be granted without a Finnish personal identity code.
Shortage notifications are published on the website two weeks before the start of the shortage
From now on, shortage notifications are published on the Fimea website two weeks before the start of the shortage. The shortage notifications are published in the same location as before, at Fimea's shortage search. Shortage information is also available as open data.
The new e-service and the revised publication schedule will improve the quality of shortage information. Data in Fimea’s Register for Medicinal Products has been combined with the e-service, which is expected to reduce the possibility of human errors when submitting notifications. In addition, the new publication schedule keeps the shortage information on the website more up-to-date.
Fimea would like companies to report shortages as early as possible. Under the Finnish law, a shortage notification must be submitted at least two months before the start of the shortage. Informing Fimea of a potential shortage as early as possible helps in preventing the effects of the shortage on medical treatment.
News article: E-service for reporting shortages is coming along
This news article has been updated on 31.5.2023: Instructions for Suomi.fi e-Authorization in English and 8.6.2023: Instructions for using the e-service for reporting shortages
- Satu Suvanto, Senior Pharmaceutical Inspector, tel. +358 29 522 3250
- Päivi Luhtanen, Senior Inspector, tel. +358 29 522 3263
- E-mail addresses are in the format email@example.com