Questions and answers about the online application for narcotic drugs order forms narcoreg.be

No, since 1 September 2023, the digital system is compulsory. This also means that monthly sales records will no longer have to be provided to the FAMHP by e-mail.

You must record both purchases and sales.

Erroneous deliveries do not need to be registered.

Cancelling an incorrect declaration
If declarations have been submitted anyway, they should be cancelled (see user guide, §6.).

When using REST interface or CSV upload: please contact your software developer for more details on how this is implemented in your software. If this functionality is not available, you must carry out the cancellation manually via www.narcoreg.be (see user guide, §6.).

Registration of a correct delivery:
The correct delivery must be registered in Narcoreg with a new delivery date. Both the supplier and the recipient must do so.

No later than 30 days after receipt or shipment of the goods.

You have 30 calendar days from the day a product is received/shipped. A recipient can only register a delivery into the system if he has received the products (receipt date is required). Verification by the FAMHP is thus done a posteriori.

When the FAMHP determines that certain declarations are missing, a reminder email is sent inviting the recipient to submit the missing declarations. Since 1 January 2024, this reminder, as well as any subsequent reminder in the absence of follow-up, entails the application of an automatically generated fee.

No, verification is done by the FAMHP.

Both purchases and sales must be registered into the system.

Any user for whom the access has been configured according to the user guide, can submit a declaration.

Yes, this is mandatory for the substances referred to in Annexes I, II, III and IV.

This is no longer mandatory since 1 September 2023.

No, only the delivery and receipt in Belgium must be registered.

It is possible to submit entries a posteriori.

A return is registered in Narcoreg as a "sale" by the returning party and as a "purchase" by the party receiving the return. These are merely system terms used to register the transaction and do not reflect an actual sale or purchase.

Please note that the return of a wrong delivery should not be registered in the system. See also question above.

These will need to be registered by receipt date.

Yes, it is possible to modify a declaration afterwards. Please refer to paragraph §7 of the manual.
Please note that only declarations submitted after the May 2025 update can be modified.

Yes, it is possible to delete a declaration afterwards. Please refer to paragraph §6 of the manual.
Please note that only declarations submitted after the May 2025 update can be deleted.

Yes, the check of the licensed substances/remarks in the scope of the licence is not carried out by the system.

Example scenario:
Pharmacy X intends to carry out IMP but outsources this to Pharmacy Y, which has the appropriate facilities.

• Delivery: The wholesaler delivers the complete packages of medicines directly to Pharmacy Y.
• Processing: Pharmacy Y prepares the medicines and sends the finished IMP products to Pharmacy X.

Registration in Narcoreg:
• The wholesaler registers the delivery of the complete packages to the trading partner, Pharmacy X.
• Pharmacy X then registers these full packages with the trading partner Wholesaler, based on the invoice or (copy of) the shipping note.

Important: Pharmacy Y does not register anything in Narcoreg. This explains why outsourced IMP activities are not visible in the system.

Outsourced fractionation activities do not need to be registered.

Example scenario:
Pharmacy X outsources the preparation to Compounding Pharmacy Y, which has the appropriate facilities.

• Delivery: the wholesaler sells and delivers the necessary pharmaceutical raw materials or medicines directly to Compounding Pharmacy Y.
• Completion: compounding Pharmacy Y produces the magistral preparation and supplies it to Pharmacy X.

Registration in Narcoreg:
• Wholesaler: registers the delivery of pharmaceutical raw materials or medicines (total number of packages) to Compounding Pharmacy Y.
• Compounding Pharmacy Y: subsequently registers the receipt (purchase) of these pharmaceutical raw materials or medicines (total number of packages).

Important: the outsourcing pharmacy (Pharmacy X) does not register anything in Narcoreg, which means the outsourcing of magistral preparations is not reflected in the system.

The name of the person holding that position is mentioned in the Crossroads Bank for Enterprises (CBE).
The FAMHP has no visibility into what is configured for your company through CSAM. If you are known in CSAM, you can log in via this link using e-ID or itsme by clicking on "Access management" on the right. Select your company and click on "Your responsible persons" at the top right. There you will find the name of the principal access manager you can contact internally.

If the legal representative does not have a national register number, they can use the bis number. To do so, follow the instructions in the user guide (§ 2.2.1.).

Yes, that person can continue to do so. Your organisation needs to appoint a principal access manager (PAM) in CSAM. Afterwards, the PAM can designate an access manager (AM) or a user from amongst your distributor's staff to be responsible for your declarations. You can then continue to access these declarations on Narcoreg. Please note that access to Narcoreg for staff members of your organisation must also be configured according to the user guide so that they can continue to access the declarations.

Yes, anyone with access to Narcoreg on behalf of the organisation can access each other's declarations.

No, filling in one of both fields is enough to submit a declaration. The system automatically completes the other field. However, both fields can be filled in manually if preferred.

The unit to be used is described in the user guide, as well as on Narcoreg, and is as follows:

• for raw materials in bulk = grams;
• for pharmaceutical raw materials = per (complete) package.

For example: for morphine HCl (narcotic code 061200), you have to work in grams, while for morphine HCl FSA 5 G (narcotic code 061308 and CNK 4486924) you have to work per package.

Yes, the CSV file, and therefore the declarations, cannot be uploaded without "headers".

Yes, receipt must be registered in Narcoreg. However, the paper order form should still be retained.

A narcotic drugs order form prepared in September may be cancelled and destroyed, unless it is an overdue correction of a delivery that took place before 1 September. In that case, the narcotic drugs order form must be retained.

Paper narcotic drugs order forms are no longer used since 1 September 2023, and you can destroy them by tearing them up.

Please open both files via Notepad to view the zeros:

a. Find the CSV file on your computer.
b. Right-click on the file.
c. Select "Open with" and choose "Notepad" from the list of programs.

This is possible. Please contact narcotics@fagg-afmps.be for more information.

The recipient enters the code of the branch delivering the narcotic drugs (see shipping note).
The branch delivering the narcotic drugs should also register the sale of these products.

When moving to a new place of operations, the current licence will be terminated, and you will receive a new licence. The transfer of narcotics from the old to the new licence number must be registered in Narcoreg in a timely manner.

No, these shipments do not need to be registered in Narcoreg, neither by the sender nor by the receiving analytical laboratory. Such transactions are traceable via the in/out register and are therefore exempt from the Narcoreg registration requirement.

	Pharmacist in charge	Deputy	Substitute	Trainee
Pharmacy open to the public	ü	ü	ü	û
Hospital pharmacy	ü	ü	û	ü

 

No, deputy pharmacists or substitute pharmacists can also access Narcoreg. However, substitute pharmacists must first be configured in CSAM by the principal access manager (PAM) before they can log in. The user guide (§ 2.1) describes the configuration procedure step by step.

 

Contact the NIHDI by sending an e-mail to dossierpharma@riziv-inami.fgov.be to verify your details as a deputy pharmacist.

 

Substitute pharmacists for a pharmacy open to the public must first be configured in CSAM by the principal access manager (PAM) before they can log in. The user guide (§ 2.1) describes the configuration procedure step by step. Only pharmacists in charge and deputy pharmacists can currently log into the system without prior configuration. Please note that pharmacists in charge without Belgian nationality must exceptionally be configured in CSAM.

 

Hospital pharmacists in training (ZAIO) can contact the NIHDI at dossierpharma@riziv-inami.fgov.be to register as deputy pharmacists. This way, they can access Narcoreg.

 

The institution number consists of eight digits, namely your APB number and two control digits. The institution number corresponds to the NIHDI number of the pharmacy. The pharmacist in charge can find this number as follows: a. log into the web application; b. click on "Submit a declaration"; c. the number next to "Declarant ID" corresponds to the institution number.

 

• If you are a substitute pharmacist who is not in charge of another pharmacy: 

In such cases, eHealth recommends that the substitute pharmacist be appointed "co-pharmacist in charge" in order to gain access.  This can be done through the NIHDI (dossierpharma@riziv-inami.fgov.be). 
Another possibility is that the deputy pharmacist logs into Narcoreg, as he or she has direct access. See previous questions if the deputy would not have access anyway.

• If you are a substitute pharmacist who is already in charge of another pharmacy:

In such cases, a deputy pharmacist will have to log into Narcoreg, as he or she does have direct access. See previous if the deputy would not have access anyway.
 

 

If you already know who will replace you, it's best to take care of your substitute's access right now. This can be done by following §2.1 from the user guide. Additionally, through CSAM, it is possible to appoint a co-principal access manager (co-PAM) or an access manager (AM) who can also give access to substitute pharmacists. This applies not only to Narcoreg, but also to other eHealth applications. It may be interesting for pharmacy chains to appoint persons from higher up as co-PAM or AM in case of absence of the pharmacist in charge. The CSAM user guide (available in Dutch or French) explains how co-PAMs or AMs can be appointed. The pharmacist in charge will have to take care of this as the principal access manager.

 

You can designate a principal access manager (PAM) using the exception procedure. To do so, follow the instructions in the user guide (§ 2.1.).

 

Please contact the NIHDI by sending an e-mail to dossierpharma@riziv-inami.fgov.be stating that you are no longer employed by your former employer. The NIHDI can then make the necessary changes in coBRHA. This is important as our application retrieves its data from coBRHA.

 

• Pharmacy open to the public: notify the FAMHP via registration_pharmacy@fagg-afmps.be 
• Hospital pharmacy: notify both the FAMHP via registration_pharmacy@fagg-afmps.be and the NIHDI via dossierpharma@riziv-inami.fgov.be 

 

You must record purchases, sales (helping out other pharmacies in urgent cases) or returns to wholesalers. Sales to patients do not have to be recorded. Please note that the return of a wrong delivery by the wholesaler does not have to be recorded in the system. See also question 3.

 

This transaction must be registered, both by sender and receiver. For example: pharmacy X supplies pharmacy Y. Pharmacy X (supplier) registers a sale in Narcoreg, no later than 30 days after shipment of the goods. Pharmacy Y (receiver) registers a purchase in Narcoreg, no later than 30 days after receipt of the goods.

 

No

 

This is entered into the system as a "sale" by the pharmacy and a "purchase" by the wholesaler. These are merely terms used in the system to record the transaction and do not reflect an actual sale or purchase. Please note that the return of a wrong delivery by the wholesaler does not have to be recorded in the system.

 

No, neither party has to report that in Narcoreg. The order form is still used as was the case previously.

 

In the event of a merger whereby anaesthetics are taken over by one of the pharmacies, the transfer must be registered in Narcoreg on time. Please note, once a pharmacy's APB number is set inactive in Narcoreg, it cannot be reactivated.

 

No, neither party has to report that in Narcoreg. The order form is still used as was the case previously.

 

Yes, the veterinary wholesaler records the purchase through Narcoreg, the veterinary manufacturer records the sale through Narcoreg.

 

Yes, the veterinary wholesaler records the sale through Narcoreg, the veterinarian records the purchase through Narcoreg.

 

Yes, the purchasing wholesaler records the purchase through Narcoreg, the selling wholesaler records the sale through Narcoreg.