Cancelling a marketing authorisation or registration

The holder of a marketing authorisation or registration, or a person or company authorised by the holder shall notify Fimea in writing before the end of the year of the authorisation, if the authorisation will be cancelled and the annual fee not paid.  The notification must be written on the form available on the Fimea website, and sent by mail to Lääkealan turvallisuus- ja kehittämiskeskus Fimea, PL 55, 00034 FIMEA, Finland or faxed to +359 29 522 3002. The authorisation is cancelled on the date specified by the holder. If the cancellation date is not stated in the notification, the cancellation will take effect on the date of the cancellation notice. The marketing authorisation or registration cannot be cancelled retroactively.

Fimea will a confirmation of the cancellation to the holder of the marketing authorisation or registration only upon request.

Cancelling a marketing authorisation for safety reasons

If the cancellation of a marketing authorisation is based on adverse effects, efficacy, a negative risk to benefit ratio, or problems with drug safety, the European Medicines Agency (EMA) must also be notified. If actions have been taken outside the EU and EEA for reasons related to adverse effects, efficacy, a negative risk to benefits ratio or problems with drug safety, Fimea and EMA must be notified immediately. The notification on the cancelling of a marketing authorisation must contain two documents describing the reasons – a cover letter and a notification report table ’Notification of withdrawn products’. These documents must be submitted both to Fimea and EMA.