Belgium
New measures concerning pregabalin and gabapentin entered into force on July 19, 2026.
In the meantime, an erratum has been published in the Belgian Official Gazette. The correction was necessary because the last line of the table included in the new Annex IVC was inadvertently omitted from the publication of March 19, 2026.
For a complete and up-to-date overview of the annexes to the RD of 06.09.2017 , we refer you to the FAMHP website, where the relevant Annex IV can be consulted.
We refer to our previous communication (see below) for further information regarding the main implications of these changes. Please note that, naturally, all other existing obligations continue to apply, including:
- Notification to the FAMHP of any unexplained losses (Article 29 of RD 06.09.2017);
- Maintenance of the mandatory inbound and outbound register (“in-out register”) (Article 25 of RD 06.09.2017).
As from July 19, 2026, the destruction of (bulk) raw materials containing the affected substances will also be subject to prior FAMHP check (Article 45 of RD 06.09.2017).
The following references are concerned:
| Narcoreg code | Name | CNK | |
| 877000 | PREGABALINE | / | |
| 877002 | PREGABALINE FAGRON 50 G | 4869699 | |
| 878000 | GABAPENTINE | / | |
| 878002 | GABAPENTINE FAGRON 25 G | 4688016 | |
| 878003 | GABAPENTINE FAGRON 250 G | 4515524 | |
| 878004 | GABAPENTINE PCH 25 G | 4804092 | |
| 878005 | GABAPENTINE PCH 250 G | 4283339 | |
| 878006 | GABAPENTINE FEBELCARE 25 G | 4901070 | |
| 878007 | GABAPENTINE MAGIS-PHARMA 25 G | 4178596 |
These codes are already active in Narcoreg. However, registration in Narcoreg will only become mandatory for deliveries and receipts taking place from July 19, 2026 onwards.
Companies that, for organizational reasons, wish to start registering these transactions in Narcoreg before that date may already do so.