Belgium
As from 11 December 2025, a new Royal Decree (RD) has entered into force that substantially amends the rules concerning parallel distribution and parallel import of medicinal products for human use in Belgium. This Decree replaces the Royal Decree of 19 April 2001 on parallel import and parallel distribution.
The new Royal Decree simplifies administrative procedures and enhances transparency, by introducing
- harmonized digital submission process,
- clear timelines for assessment,
- more extensive and precisely defined application requirements,
- an explicitly elaborated framework for variations and pharmacovigilance obligations, and
- the suspension or termination of parallel import authorizations.
In addition to the Royal Decree, the guidance document for the submission of applications for parallel import authorizations or for variations to such authorizations has also been fully revised.
For further information, please refer to the following websites: