Year-end withdrawals medicines for human use
Requests to withdraw marketing authorisations and parallel import marketing authorisations as of 31 December 2020, the so-called 'year-end withdrawals' for medicinal products for human use, must be received by the Medicines Evaluation Board (MEB) by 1 November 2020 at the latest, in order to be processed on time.
Withdrawals with a combined package leaflet must be submitted per group of medicinal products in a separate CESP. It is not possible to process several groups of medicinal products in a single CESP submission. However, withdrawals without an amended package leaflet can still be submitted in 1 CESP.
A withdrawal request that is received by the MEB on 2 November or later, will only be processed after 1 January 2021. This means that the authorisation will not have been cancelled on 31 December 2020 and that the annual fee for 2021 will therefore be payable.
If the MEB receives the withdrawal request on time, but an authorisation is not withdrawn on 31 December 2020 due to ongoing discussions about the need to keep the product available for patients, an invoice for the annual fee will be issued. If the product is withdrawn after all in January or February, the marketing authorisation holder will receive a credit note.