In Belgium, any delivery or receipt of narcotic drugs and psychotropic substances listed in Annexes I, II and IV (excluding preparations listed in Annexes Ic and IVc) of the Royal Decree of 6 September 2017 must be registered in the FAMHP's online application for narcotic drugs order forms: www.narcoreg.be.
From 1 September 2023, the digital system will be mandatory and will replace the paper forms. The paper narcotic drugs order forms will no longer be used from 1 September and may be destroyed by you by tearing them up. This also means that monthly sales records will no longer need to be provided to the FAMHP by email.
How does the online application work ?
The declaration in the system occurs a posteriori, maximum 30 days after receipt or shipment of the goods.
Declarations can be transmitted in three ways.
- Submitting declarations one by one in the web application.
- Bulk upload via a CSV file in the web application. The template of the CSV file is available in the web application.
- REST interface (machine-to-machine): the system integrates with existing software, the user's software communicates with the system without user intervention. A REST (representational state transfer) interface is available for this purpose. REST is a technology that allows a software application to communicate in a fairly simple way with a server offering a particular service. Very often the HTTP standard is used for this purpose (GET, POST, etc.). A cookbook is available for developers of the software integration. You can request it at narcotics@fagg-afmps.be. Whether or not to integrate with your existing software is a non-binding decision between you and your software supplier.
A detailed user guide is available in the online application for narcotic drugs user forms. We have compiled the frequently asked questions in an overview (questions and answers).
The supplier should no longer needs to email monthly sales records to the FAMHP. It is sufficient that sales are submitted into the system in a timely manner.
A non-exhaustive list of drugs and raw materials authorised to be used in pharmacies, for which a declaration must be filed in the system, is available in the web application.
All operators are expected to verify the delivery address and deliver only to authorised addresses. This is not only a requirement based on the aforementioned Royal Decree, but is also a requirement under the Good Distribution Practices (GDP) rules.
In addition, it is extremely important that any change in a trading partner's data is reported in time to the competent services.
- For a pharmacy open to the public, changes must always be reported to the Registration of Pharmacies service via the registration form.
- Please note that an incomplete file or a file pending with this service may cause a significant delay for delivery.
- In case of a hospital pharmacy, changes should be reported to the inspectors of hospital pharmacies (contact details: Hospital Pharmacy - Human use - FAMHP).
Fees
As of 1 January 2024, each reminder carried out by the FAMHP to register a delivery or receipt on www.narcoreg.be is accompanied by a fee of €32.06 per reminder.
This fee will be indexed annually.
Contact
narcotics@fagg-afmps.be