Fimea’s administrative regulation ‘Applying for and maintaining a marketing authorisation and registration for a medicinal product’ has been updated

Fimea’s administrative regulation 2/2017 ‘Applying for and maintaining a marketing authorisation and registration for a medicinal product’ has been updated to version 2/2018. The update concerns medicinal products that have been granted marketing authorisation under the centralised procedure for which national variations cannot be provided in the future. Additionally, revisions have been made concerning keeping a medicinal product on the market in packages of two different marketing authorisation holders, in two different compositions, or under two different names.

The update also specifies in greater detail the obligations concerning the discontinuation of, or temporary interruptions to, market availability based on a change in (weakening of) the benefit-to-risk ratio, the cancellation of a marketing authorisation, or a decision of not applying for a renewal of a marketing authorisation.

Fimea’s administrative regulation (pdf)