Each year, the MEB receives a large number of requests from marketing authorisation holders to withdraw the marketing authorisation for a medicinal product. Also, marketing authorization holders inform the MEB that a medicinal product will no longer stay on the market. In most cases, the MEB does not foresee any problems. This is the case 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 or taking a product off the market 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.
When does the MEB foresee problems?
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.
- Similar medicinal products which are authorised, are not on the market.
- Withdrawal of the medicinal product's marketing authorisation has consequences for the use in specific patient groups, for example children (e.g., the alternative might have a higher strength or a different pharmaceutical form).
- Withdrawal of the medicinal product's marketing authorisation jeopardises the patient and/or user friendliness (e.g. the alternative might have a different pharmaceutical form).
- Withdrawal of the medicinal product's marketing authorisation may have consequences for interchangeability, for example because the alternative products contain other excipients. This may cause problems in certain patients (like hypersensitivity reactions) when switching to the alternative product.
Request for takeover of marketing authorisation
As long as a marketing authorization is not withdrawn, other companies have the opportunity to take over the marketing authorization. To increase the opportunity for a takeover, the MEB publishes information on (proposed) withdrawals in which the MEB finds that patients’ interests may be at stake on this website in a news article. These publications contain the MEB’s considerations and point of view. The news overview at the bottom of this page contains these articles.
Proposed withdrawals become 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. Interested companies can contact the current marketing authorisation holder. Once a marketing authorisation has been withdrawn, it is no longer possible to transfer the withdrawn marketing authorisation to another company.
An overview of recently withdrawn marketing authorisation is published on the Medicines Information Bank, under ‘Withdrawn and suspended marketing authorisations’.
