To marketing authorisation holders: The process for notifying shortages will change gradually starting from 1 October 2019
The marketing authorisation holders’ process for notifying shortages to Fimea will be revised gradually starting from 1 October, on which date the new notification forms will be put to use.
The guidelines to harmonise the marketing authorisation holders’ processes for notifying shortages, planned in collaboration by the EU’s pharmaceutical regulatory authorities, have been taken into account in the changes. The objective is also to develop the process for notifying shortages as part of the FimeaWeb medicines search upgrade project.
Communicating and notifying shortages becomes easier
In addition to improving the process for notifying shortages of medicinal products, Fimea also develops its own communications pertaining to shortages. Information about shortages of medicinal products will be made more readily available to the healthcare professionals who prescribe and dispense medicines as part of their work.
Fimea will revise the FimeaWeb search service on its website. The collected data can more widely utilised in the future when the information about shortages in availability will be made available in a more usable format.
In future, information about shortages of medicinal products will be displayed in the medicines search if there is currently an interruption in the availability of the medicinal product searched for. A direct link will open more detailed information about the interruption in availability, such as its estimated duration.
Additionally, a dedicated search engine will be added to the shortages page that can be used to search for specific products or active substances and the availability information pertaining to them. The development project is due for completion at the turn of the year.
Fimea currently publishes the notifications about temporary shortages of medicinal products received from marketing authorisation holders on its website in pdf format. The notification of shortage forms and their attachments will no longer be published on the website when the new medicines search and shortage search features have been placed in service.
Instructions for marketing authorisation holders for notifying interruptions in availability
If the interruption starts before 1 October 2019
- The interruption in availability can be notified using the current or revised availability issue notification form. The entire form shall be filled out and submitted to Fimea by e-mail at firstname.lastname@example.org.
- Fimea will publish the form on its website as is, see the section on notifications of shortages
- Fimea also recommends that the notification of shortage be accompanied by an attachment that describes the shortage in more specific detail. Submitting the attachment to the notification of shortage is voluntary up until the turn of the year. The file attachment must be submitted to Fimea as secure mail. The attachment or any data contained in it will not be published on the website.
Reporting an interruption as of 1 October 2019
- All notifications of shortages shall be made using the new notification form, including updates to previous notifications.
Revised process for notifying shortages as of 1 January 2020 (target schedule)
- The marketing authorisation holder may submit a notification of shortage and the details included in its attachment to Fimea via secure mail as an Excel file instead of separate forms. Fimea will publish an Excel template on its website prior to the turn of the year and provide a more detailed deployment schedule. The submission of an Excel file will be possible when Fimea’s medicines search upgrade has been brought to completion.
Updated notification form complete with appendices:
EMA’s press release 04/07/2019 (improvements to reporting and communicating availability issues, in English)
For further information, please contact:
Information in the forms:
Johanna Linnolahti, Head of Section, tel. +358 29 522 3231
Päivi Luhtanen, Pharmacist, tel. +358 29 522 3263
Forms and their receipt:
Registry office, tel. +358 29 522 3602 (forms and their receipt)
E-mail address format: email@example.com