Each year, the MEB receives a large number of requests from marketing authorisation holders to withdraw the marketing authorisation for a medicinal product. The MEB usually honours these requests without further discussion. For example, if there are sufficient other medicinal products with the same active ingredient for which authorisations have been granted.
However, sometimes the withdrawal of the marketing authorisation may pose problems to patients. In those cases, the MEB explores which other possibilities there are to retain the product for the Dutch market. The MEB will usually do this in consultation with the marketing authorisation holder.
At the bottom of this page, you can download the overviews of withdrawals of marketing authorisations following consideration of patients’ interest as from 2011. An overview of withdrawals in the past 4 weeks can be found in the MEB Medicines Information Bank.
The MEB finds that patients' interests may be at stake in the following situation(s):
- It concerns the only medicinal product that is still authorised in the Netherlands with the active ingredient and/or in the pharmaceutical form for indications approved in the product information, or doubts remain about the availability of alternatives.
- It concerns a medicinal product for which a marketing authorisation has been granted in the Netherlands with the active ingredient and/or in the pharmaceutical form for indications approved in the product information, or doubts remain about the availability of alternatives for which marketing authorisations have been granted.
- Withdrawal of the medicinal product's marketing authorisation has consequences for the use in specific patient groups, for example children.
- Withdrawal of the medicinal product's marketing authorisation jeopardises the patient and/or user friendliness.
- Withdrawal of the medicinal product's marketing authorisation may have consequences for interchangeability, because the alternative products do not contain excipients, or do contain (other) excipients, which impacts on interchangeability.
The overviews of withdrawals following consideration of patients’ interest below state the MEB's considerations and points of views in these special situations.
The overviews also list the proposed withdrawals of marketing authorisations. According to the MEB, these withdrawals may pose problems to patients and no replacement for the medicinal product has been found.
The proposed withdrawal becomes final 6 months after publication in the overview. The MEB announces this in advance to offer other companies the opportunity to take over the marketing authorisation. Once a marketing authorisation has been withdrawn, it is no longer possible to transfer the withdrawn marketing authorisation to another company.