Article 105/1 of the Royal Decree of 14 December 2006 on medicinal products for human use states that the wholesaler may place a medicinal product on the market that is not authorised in Belgium if it meets a special need in Belgium due to critical unavailability. This is only possible if the minister or their delegate has not opposed its marketing, delivery and administration within 10 working days after the notification.
This provision provides that the FAMHP may request additional data. In this case, the 10-working-day period is temporarily suspended until the date that the requested data are submitted. If the requested data are not submitted to the FAMHP within 5 working days, the notification will be considered inadmissible.
If you have any questions as a wholesaler prior to the initial notification, please contact supply-problems@fagg-afmps.be.
After submitting the form, you will receive an application number from supply-problems@fagg-afmps.be within 10 working days. Please mention this number in any communication or notification about this form, such as any changes, start of distribution or stock exhaustion.
Privacy statement
The personal data collected in the context of this notification, including the contact person's first name, surname, e-mail address and telephone number, will be used exclusively by the FAMHP to assess and process your notification for the temporary importation of medicinal products in situations of critical unavailability, in accordance with the Royal Decree of 12 September 2024 amending the Royal Decree of 14 December 2006 and the GDPR. This data will be kept for the time strictly necessary to manage the notification and will not be shared with third parties without prior consent. For more information, please consult our privacy statement.
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