BRIEF—Netherlands: Year-end withdrawals medicines for human use

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

A withdrawal request that arrives at the MEB on November 2 or later, will be completed only after January 1, 2020.

This means that the marketing authorisation is not withdrawn on December 31. 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In case the request for withdrawal is received by the MEB in time, but the product is not withdrawn on December 31 because of ongoing discussion on the necessity to keep the product available for patients, the invoice for the annual fee will be sent.

If the product is withdrawn in January of February after all, the marketing authorization holder will receive a credit note.