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Withdrawal of marketing authorisation; 'stock clearance window'

There is no stipulation in the Medicines Act which allows a medical product to be sold for 12 months after its registration has been withdrawn. This so-called ‘stock clearance window’ (and its corresponding conditions) was previously laid down in Article 22 of the Registration of Medicines Decree (Besluit Registratie Geneesmiddelen) but the arrangement has expired with the introduction of the Medicines Act.

The industry and health care sector have contacted the Ministry of Health, the Medicines Evaluation Board and the Inspectorate to query the withdrawal of this special dispensation. The three authorities are now reviewing policy in this regard. As soon as a decision is made, it will be communicated to the field. In the meantime, the Inspectorate will exercise discretion while continuing to fulfil its statutory obligation to enforce extant legislation.