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marketing authorization of registration must notify Fimea when a medicinal product is introduced to the market or when withdrawn from the market permanently.

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 withdrawals at least two months in advance.

The holder of the marketing authorisation or registration must also notify Fimea when an exemption package is placed on the market and when its marketing is discontinued. For exemption packages introduced to the market, a Nordic product number (Vnr) must be applied for if it does not already exist for that specific package. If there is already a corresponding package on the market with a Vnr number, a separate number does not need to be applied for the exemption package. The discontinuation of the marketing of an exemption package must also be notified to Fimea in accordance with the instructions.

Notifications of introduction to the market withdrawals from the market should be sent to [email protected]. Paper versions does not have to be sent by regular mail.