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Release of the European Shortages Monitoring Platform
Europe As part of Regulation (EU) 2022/123, an EU platform has been realised to prevent, monitor, and manage any medicine shortages across the EU of centrally authorised medicines. The European Shortages Monitoring Platform (ESMP) has the purpose to facilitate...
Import medicines special needs
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...
RD 12/09/2024 amending RD 14/12/2006: Addition of two elements regarding the distribution of unauthorised drugs, in case of unavailability
Belgium The Royal Decree published on 30 September 2024, amending the Royal Decree of 14 December 2006 on medicinal products for human and veterinary use, adds two elements concerning the search for substitutes, in the event of unavailability. In the first place, a...
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