In Belgium, any delivery or receipt of narcotic drugs and psychotropic substances must be reported to the FAMHP. From 1 September 2023, the new online application of the FAMHP, that replaces the paper narcotic drugs order forms, must be used for that purpose. A transition period has been set, starting 1 July 2023.
The new application www.narcoreg.be offers numerous advantages. Above all, it will save pharmacists time and effort, especially if it is integrated into their existing software. But the application will also streamline the process for manufacturers, wholesalers and FAMPH staff. The application also makes it possible to establish a more secure communication between different operators and the FAMHP. The system also allows data to be more easily accessed for statistical analysis or detection of excessive use or lost products.
Transition period
From 1 July 2023 to 31 August 2023, there will be a transition period during which the new system will be accessible to all operators. During this period, it remains a legal requirement to continue to use paper forms and provide monthly sales records to the FAMHP. The transition period is designed to get familiar with the new system and the procedure, as well as to verify that the data provided by operators is received and processed correctly. Data entry into the new system is then voluntary.
From 1 September 2023, the digital system will be mandatory and paper forms will belong to the past. 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 online application occurs a posteriori, maximum 30 days after receipt or shipment of the goods.
All transfers of substances listed in Annexes I, II and IV (excluding those listed in Annexes Ic and IVc) of the Royal Decree of 6 September 2017 must be reported through the new system.
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. The HTTP standard is very often used for this purpose. A cookbook is available for developers of the software integration. It is available 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.
The paper narcotic drugs order forms will no longer be used from 1 September and may be destroyed. The supplier should no longer provide monthly sales records to the FAMHP by e-mail. It is sufficient that sales are submitted timely into the system.
More information
Specially reglemented substances – Reporting national trade
User manual narcoreg.be
Questions and answers
Questions?
narcotics@fagg-afmps.be