Introduction to market
Pursuant to the Medicines Act, section 27, the holder of a marketing authorisation or registration must notify Fimea when a medicinal product is introduced to market or when withdrawn from the market either permanently or temporarily.
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 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 authorisation has been transferred to a new holder.
The notification is made with this form at least 8 working days before the sales begin.
Fimea must be notified of temporary or permanent withdrawals at least two months in advance, except when special conditions preclude this. Form for withdrawing a product from the market.