From 11 December 2025, a new Royal Decree will come in force that fundamentally changes the rules on parallel distribution and parallel import of medicinal products for human use in Belgium. The decree simplifies administrative steps and provides more transparency.
On 11 December 2025, the new Royal Decree restructuring the regulations on parallel distribution and parallel import of medicinal products for human use will come into force. The reform aims to streamline procedures and improve communication between the actors involved.
What does this mean for you
The new Royal Decree brings some important changes for distributors of medicinal products for human use through parallel distribution and parallel import. The aim is to simplify administrative procedures, make them more efficient and streamlined. In addition, the decree provides greater clarity in communication, deadlines and expectations.
Parallel import
The new Royal Decree adjusted the required documents for submitting a parallel import application. These include the Parallel Import Authorisation (PIA) and the application form. New on the list of requirements is the comparison form.
In addition, the guideline for submitting applications has been completely rewritten. This updated guideline provides practical assistance in preparing and submitting an application and helps applicants meet the requirements set out in the Royal Decree.
Parallel distribution
Although parallel distribution falls under the competence of the European Medicines Agency (EMA), the Royal Decree brings changes in that area too.
In particular, the responsibilities of the parties concerned are more clearly defined and better delineated.
More information
Parallel import
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