Fimea reminds marketing authorisation holders to notify shortages in the supply of medicines
Notifying to Fimea of shortages in the supply of medicines is a legal obligation, the fulfilment of which is at the responsibility of the marketing authorisation holder. The marketing authorisation holder is also responsible for duly submitting the required information with the form found on Fimea’s website. The legal obligation is to submit a notification at least two months before the start of a shortage. Fimea is developing its notification process towards a more customer-friendly format as part of the development of electronic submission.
Fimea monitors more effectively the notification of shortages, the storage situation of pharmaceutical wholesalers and mandatory reserve supplies due to the Covid-19 pandemic. In order to receive an updated situation picture, it is important that notifications and applications are made in due time and with correct information. This enables the actors in the pharmaceutical sector and healthcare professionals to take the changes in the supply situation into account.
Updates in forms and advance notification of a potential shortage
In order to better review the situation picture, the appendix including confidential business and professional information has been complemented with fields concerning the following delivery and risk-management activities. Fimea needs this information as soon as possible after the original report. If submitted as an Excel file, the file should be immediately submitted once the shortage in the supply is reported. Information containing confidential business and professional information is requested to be submitted to Fimea as secure mail.
Marketing authorisation holders are also provided with the possibility to report in advance of a potential shortage with a free-form notification submitted to Fimea’s registry office. This reporting possibility does not substitute the official notification of a shortage, on the basis of which the information related to the shortage is published on Fimea’s website. When the shortage is confirmed, the notification on the shortage must be submitted through a normal reporting procedure to Fimea, in order for it to provide this information for consumers and healthcare professionals.
- Johanna Linnolahti, Head of Division, tel. + 358 29 522 3231
- Päivi Luhtanen, Pharmacist, tel. + 358 29 522 3263
- E-mail address format: email@example.com