Introduction to market and shortage notifications
Introduction to market
Pursuant to the Medicines Act, section 27 the holder of a marketing authorization of registration must notify Fimea when a medicinal product is introduced to the market or when withdrawn from the market permanently or temporarily (= shortage notifications).
A product is considered to be on the market when it has been released for distribution and is available for the end users.
The notification of introduction to the market is made when the preparation is introduced to the market and whenever the composition, trade name or Nordic product number changes and when the marketing authorization has been transferred to the new holder. The notification should be made at least 8 working days before the sales begin.
Fimea must be notified of temporary or permanent withdrawals at least two months in advance.
Notifications of introduction to the market, permanent or temporary withdrawals from the market should be sent to email@example.com. Paper versions does not have to be sent by regular mail.