Belgium
The new article 105/1 of the Royal Decree of 14 December 2006 on medicinal products for human use entered into force on 1 November 2024.
This provision allows wholesalers in possession of an authorisation to purchase medicinal products (WDA) to place unlicensed medicinal products on the Belgian market if they meet a special need due to a critical unavailability and if no other solutions than the importation of the therapeutic equivalent or alternative are possible and only for a period limited to the duration of the unavailability.
The FAMHP has drawn up a list of critical unavailabilities, which is published and updated on FarmaStatus. The procedure to be followed to apply for these exemptions can be found in the below FAMHP notice.
FAMPHP notice:
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