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

No, from 1 September 2023, the digital system will be 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.

 

Wrong narcotic drugs should not be registered into the system. 
Correction of earlier registrations: 
If one of the two parties - i. e. the party either delivering (supplier) or receiving (receiver) the wrong narcotic drugs - registered a wrong delivery into the system before the error was detected, that party must register the delivery a second time with a negative quantity to correct this error.

• Cancellation by the supplier only: if the supplier - but not the receiver - registered the delivery into the system, only the supplier must cancel the delivery by recording a negative quantity (see §3.2. "minus declaration" in the user guide).
•  Cancellation by the receiver only: if the receiver - but not the supplier - registered the delivery into the system, only the receiver must cancel the delivery by recording a negative quantity (see §3.2. "minus declaration" in the user guide).
• Cancellation of a confirmed delivery: if both the receiver and the supplier have already confirmed a delivery in Narcoreg, both parties must cancel this confirmation by recording a negative quantity into the system (see §3.2. "minus declaration" in the user guide).

Please note that in case of REST interface or CSV upload, the correction, i.e. the minus declaration, can be entered using this method. Contact your software developer for further details on how to implement this functionality in your software. If this functionality is not implemented in your software, you have to manually submit this correction (minus declaration) via www.narcoreg.be.

Registration of a correct delivery: 
The correct delivery should be registered in Narcoreg with a new delivery date. Both the supplier and the receiver 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 customer can only register a delivery into the system if he or she has received the products (receipt date is required). Verification by the FAMHP is thus done a posteriori.

 

No, verification is done a posteriori 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 transfer declaration. 

 

Yes, this is mandatory for substances named in Annexes I, II, III and IV.

 

This is no longer mandatory as from 1 September 2023.

 

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

 

It is possible to submit entries a posteriori.

 

This should be registered in the system as a sale by the returning party and as a purchase by the party receiving the return. Please note that the return of a wrong delivery should not be registered in the system. See also question 3.

 

These will need to be registered by receipt date.

 

Yes, the check of the licensed substances/notice framing the authorisation is not carried out by the system.

 

The wholesaler should look at the exploitation license and should register sales on the pharmacy's APB number.

 

The name of the person holding that position is mentioned in the Crossroads Bank for Enterprises (CBE). The principal access manager can appoint you as access manager (AM) or user. 
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 (§ 2.2.3.2.2.).

 

Yes, that person can continue to do so. Your organisation needs to appoint a principal access manager (PAM) in CSAM (your organisation's legal representative). Afterwards, the PAM can designate an access manager (AM) or a user from amongst your distributor's staff to be responsible for your transfer declarations. You can then continue to access these transfer 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 transfer declarations.

 

Yes, anyone with access to Narcoreg on behalf of the organisation can access his or her colleague's transfer declarations.

 

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

 

The unit to be used for pharmaceutical raw materials is described in the procedure, as well as on Narcoreg, and is as follows:

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

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

 

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

 

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

 

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 order form must be saved.

 

Paper order forms will no longer be used from 1 September and may be destroyed by you 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.
   

 

An FTP location will be provided to this end. Please contact bonstup-integration@smals.be for more information.

 

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

 

	Pharmacist in charge	Deputy	Substitute	Trainee
Pharmacy open to the public	V	V	V	X
Hospital pharmacy	V	V	X	V

 

 

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 (§ 2.2.3.2.1 and then § 2.2.7.1) 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 (first § 2.2.3.2.1 and then § 2.2.7.1) 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 (user guide § 2.2.3.2.2.).
 

 

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 question 32 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 do have direct access. See question 32 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 first following step 2.2.3.2.1 from the user guide, and then step 2.2.7.1.

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 (§ 2.2.3.2.2.).

 

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.

 

Please contact the NIHDI by sending an e-mail to dossierpharma@riziv-inami.fgov.be

 

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

 

Yes, please notify the FAGG in good time at narcotics@fagg-afmps.be so that we can create an anaesthetic code for it. That way it can be registered in Narcoreg.

 

No, neither party has to report that in Narcoreg. The order form is still being used to that end.

 

No, neither party has to report that in Narcoreg. The order form is still being used to that end.

 

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.