Year-end withdrawals medicines for human use

Withdrawal requests for (parallel) marketing authorisations per 31 December, the so-called 'year-end withdrawals' for medicines for human use, must be received by the Medicines Evaluation Board (MEB) on 1 November 2019 at the latest, in order to be completed in time.

A withdrawal request that arrives at the MEB on 2 November or later, will be completed only after 1 January 2020. This means that the marketing authorisation is not withdrawn on 31 December. As a consequence, the annual fee for 2020 will apply.

In case the request for withdrawal is received by the MEB in time, but the product is not withdrawn on 31 December because of ongoing discussion on the necessity to keep the product available for patients, the invoice for the annual fee will be sent. If the product is withdrawn in January of February after all, the marketing authorisation holder will receive a credit note.

Octrooi