Belgium
A change has been made to the Royal Decree (RD) of 06.09.2017 regulating narcotics and psychotropic substances. The amendment includes:
- The national implementation of the substances that were approved internationally in 2025.
- An important national decision regarding pregabalin and gabapentin.
The national decision includes:
- Addition of pure substances pregabalin and gabapentin to Annex IVB.
- Addition of preparations containing specific concentration of pregabalin and gabapentin to Annex IVC.
This decision also has practical implications depending on the product, such as:
- Secure storage
- Registration in Narcoreg
- Need for an activity license
- Import/export permits (with FAMHP control)
- …
The new articles regarding pregabalin/gabapentin will effectively enter into force on July 19, 2026. Distributors of the relevant pharmaceuticals raw materials need to provide the relevant marketed products to the FAMHP so they can make the necessary preparations.
Source: FAMHP