A marketing authorisation holder may decide to have their marketing authorisation withdrawn for various reasons. A withdrawal form has been created so that requests for withdrawal can be processed as efficiently as possible. After completing the form, a document will be generated to the e-mail address provided. You can send this document, together with all the necessary supportive documents, to the MEB via CESP.
Requests for withdrawal of a product must be accompanied by the properly completed request form and the attachment to which it refers. Preferably, the web form is used for this request. Alternatively, you can use the form in ODT format. Applications for withdrawal of multiple products may be submitted at the same time, but a separate form must be used for each product.
In the case of withdrawal of a product where the SmPC is combined with that of one or more other products, two situations can arise:
The withdrawal has no consequences for the dosing instructions: in that case, you should submit a new SmPC for the remaining product(s) and declare that only the information regarding the withdrawn product has been deleted.
The withdrawal has consequences for the dosing instructions and, because of that, possibly also for the feasibility of one or more indications: all information on the product to be withdrawn should be deleted, including the no longer applicable indication. In case one or more indications are no longer applicable at least two authorised, alternative products which are authorised for the deleted indication(s) should be mentioned.
A product that is derived (i.e. RVG abcde=vwxyz) from a product of which the SmPC is combined with that of one or more other products can only be withdrawn if at the same time requests for withdrawal are submitted for all other replica marketing authorisations owned by the same marketing authorisation holder that are based on the combined SmPC in question.
Requests for withdrawal on 31 December (the year-end withdrawals) should be received by the MEB on November 1st at the latest.
A request for withdrawal submitted on 2 November or later might not be completed before the end of the year. Those requests will be completed within the usual time lines, and the date of withdrawal will be the day that the case is completed by the MEB. As a consequence the invoice for the annual fee might be sent to the marketing authorisation holder.
In case the request for withdrawal is received by the MEB before 1 November, but the product is not withdrawn on 31 December because of ongoing discussion on the necessity to keep the product available for the 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.
The enforcement of the sunset clause is laid down in Article 24 (4, 5 and 6) of the European Directive 2001/83/EC as amended and implemented in Article 47 (4) and Article 49 (5 and 6) of the Dutch Medicines Act.
Whether a product is marketed or not must be reported to the MEB via the Medicine shortages and defects notification centre. The MEB includes this information in the database.
The MEB underscores that the reporting does not automatically lead to a withdrawal of the product. If a marketing authorisation holder would like to withdraw a marketing authorisation, a separate withdrawal form must be submitted.