Withdrawal of a marketing authorisation

A withdrawal request for a product must contain an accompanying letter and a completed application form for withdrawals. You should preferably use the online form for this. Once you have completed the online form, a document will be generated and sent to the email address given by the submitting party. If necessary, the form is also available in ODT format. Withdrawal forms for multiple products can be submitted simultaneously. You should still use a separate form for each product.

When withdrawing a product for which the Summary of Product Characteristics has been combined with that of one or more other products, an amended SmPC, patient information leaflet and label text must be submitted as well. The following two situations may apply:

• Withdrawing the product will not have any consequences for the dosage instruction: in this case, submit an amended SmPC with the remaining product or products and declare that only the information about the product that is being withdrawn has been removed. If applicable, the patient information leaflet and label text must also be amended.
• The withdrawal will have consequences for the dosage instruction and, possibly, for the feasibility of one or more indications: remove all information about the product to be withdrawn, including, where relevant, all information about the indication that is no longer feasible. If applicable, the patient information leaflet and label text must also be amended.

A product that is a replica (meaning the RVG number is abcde=vwxyz) of a product for which the SmPC has been combined with that of one or more other products can only be withdrawn if a simultaneous request for withdrawal is submitted for all other replica marketing authorisations registered in the name of the same marketing authorisation holder listed in the relevant combined SmPC.

All necessary supporting documents (accompanying letter, withdrawal application form and, if applicable, an amended SmPC, patient information leaflet and label text) must be submitted to the MEB via CESP. This submission does not need to be in eCTD and is not part of the product’s life cycle.

Year-end withdrawals

Requests for withdrawal as from 31 December (‘year-end withdrawals’) must be received by the MEB by no later than 1 November if they are to be processed on time.

For requests for withdrawal that are received on or after 2 November, it may not be possible to complete them before the end fo the year. In such cases, the request for withdrawal will be processed within the usual period.  The date of withdrawal will then be the day on which the MEB finishes processing the request. This may result in an invoice for the annual fee being sent for the following year.

In the event that the request for withdrawal is received by the MEB by 1 November at the latest, but ongoing discussions about the need to keep the product available for patients prevent the authorisation from being withdrawn as from 31 December, an invoice for the annual fee will be sent out. If the product is still withdrawn in January or February, the marketing authorisation holder will receive a credit note.

Sunset clause

The implementation of the sunset rule is set out in Article 24(4), (5) and (6) of Directive 2001/83/EC and elaborated in Section 47(4) and Section 49(5) and (6) of the Medicines Act.

The MEB must be notified whenever a medicinal product is marketed on the Dutch market. This must be done via the Medicine Shortages and Defects Notification Centre. Discontinuation of the marketing of an already marketed product must also be reported via the notification centre.

The MEB emphasises that this notification will not automatically result in withdrawal of the product. If a marketing authorisation holder wants to withdraw an authorisation, a separate withdrawal form should be submitted for this.