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

1.    Questions and answers about the online application for narcotic drugs order forms www.narcoreg.be
2.    Specific questions and answers for pharmacists
3.    Specific questions and answers related to veterinary use

 

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

 

Can I choose between paper narcotic drugs order forms and the digital system?
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.

 

As a wholesaler, do I only have to record my drug purchases (which used to require a form) or also my sales?
You must record both purchases and sales.

 

The wrong narcotic drugs have been delivered to me, which I returned in a subsequent delivery round or which was picked up by the supplier. Should I also submit this as a declaration in the system?

Deliveries made in error do not have to be registered into the system. 
 

Correction of earlier registrations:  
If a party (supplier or receiver) 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 §6. "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 §6. "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 §6. "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.
 

 

When should registration be done?
No later than 30 days after receipt or shipment of the goods.

 

Declarations must be submitted monthly: does this mean that all products received in that particular month should be registered at the end of that month? Or does one effectively have one month from the day a product is received?
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.

 

As a wholesaler, should I verify that my customers have coded their purchase before I can deliver the drugs to them?
No, verification is done a posteriori by the FAMHP.

 

What should be submitted when the narcotics are received?
Both purchases and sales must be registered into the system.

 

For institutions that are not pharmacies, who can register a declaration into the system?
Any user for whom the access has been configured according to the user guide, can submit a declaration.

 

Do I still have to keep an in/out register (Royal Decree of 6 September 2017, Article 25, § 1)?
Yes, this is mandatory for the substances referred to in Annexes I, II, III and IV.

 

Do I still have to provide a monthly record of supplies of products in Annexes IA, IB, II and IVB (Article 25, § 5) to the FAMHP?
This is no longer mandatory since 1 September 2023.

 

Should I register imports and/or exports?
No, only the delivery and receipt in Belgium must be registered.

 

How can I rectify the situation if I forget something?
It is possible to submit entries a posteriori.

 

What to do in case of a return?
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 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 should not be registered in the system. See also question above.

 

In case of incomplete delivery, the system keeps the order in status "incomplete". When the rest of the order is delivered and it is complete, the order is filed away and a delivery date is assigned to the entire order. Is there a problem that products with the same CNK code from the same order, but received on a different day (i.e. received in two pieces) are still recorded in one line? Or should they effectively be registered by receipt date?
These will need to be registered by receipt date.

 

Should I still check the activity licence if I see that the purchasing wholesaler is in the system?
Yes, the check of the licensed substances/remarks in the scope of the licence is not carried out by the system.

 

How are outsourced IMP activities recorded in Narcoreg?
In outsourced IMP activities, the outsourcing pharmacy registers the complete packages of medicines as having been delivered by the wholesaler, even though the pharmacy may not have physically received the complete packages itself. The wholesaler registers the complete packages as having been delivered to the outsourcing pharmacy at one time. IMP activities are not visible in Narcoreg. Therefore, the wholesaler must provide an invoice or (copy of) the shipping note to the outsourcing pharmacy in time for it to complete the registration of the entire package within the statutory 30-day period.

 

Who is the principal access manager (PAM) for my organisation?

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.

 

How to designate the principal access manager (PAM) in CSAM if he or she does not have the Belgian nationality and therefore does not have a national register number?

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.).

 

Can our distributor continue to submit declarations instead of us as was previously the case with the paper narcotic drugs order forms? The distributor also has a person "on site" in charge of our activity licence.
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 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.

 

Can I also access my colleague's declarations?
Yes, anyone with access to Narcoreg on behalf of the organisation can access his or her colleague's declarations.

 

Should I enter both the narcotic code and the CNK code when submitting my declaration?
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.

 

Which unit should be used for raw materials?

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.
 

 

Are the "headers" in the template of the CSV file required?
Yes, the CSV file, and therefore the declarations, cannot be uploaded without "headers".

 

Do deliveries ordered before 1 September with a paper narcotic order form but delivered after 1 September have to be registered in Narcoreg?
Yes, receipt must be registered in Narcoreg. However, the paper order form should still be retained.

 

What about paper narcotic drugs order forms prepared in September 2023?
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.

 

I still have narcotic drugs paper order forms left, what should I do with them?
Paper narcotic drugs order forms are no longer used since 1 September 2023, and you can destroy them by tearing them up.

 

The leading zeros are missing from the list of trading partners and narcotic codes. Is it normal?
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.

 

As a software house, we would like to stay up-to-date on any changes to the list of trading partners and narcotic codes. Is it possible?
This is being reviewed internally. Please contact narcotics@fagg-afmps.be for more information.

 

How to register an order by proxy?
The receiver 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.

 

What to do when moving to a new place of operations?
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.

 

 

2.    Specific questions and answers for pharmacists

 

 

Who has access to Narcoreg?

 

Pharmacist in charge

Deputy

Substitute

Trainee

Pharmacy open to the public

ü

ü

ü

û

Hospital pharmacy

ü

ü

û

ü

 

Can only the pharmacist in charge register declarations?
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.

 

I am a deputy pharmacist, why can I not log into Narcoreg?
Contact the NIHDI by sending an e-mail to dossierpharma@riziv-inami.fgov.be to verify your details as a deputy pharmacist.

 

I am a substitute pharmacist for a pharmacy open to the public, why can I not log into Narcoreg?
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.

 

Do trainees also have access to Narcoreg?
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.

 

What is my institution number?
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.

 

I am a substitute pharmacist for a pharmacy open to the public. The pharmacist in charge has been absent for a long time. How can I get access to Narcoreg?
  • 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.
 

 

I am a pharmacist in charge and will soon leave on maternity leave. Do I need to take care of something for Narcoreg before I leave
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.

 

I am the pharmacist in charge and have a foreign nationality. I do not have an ID card and cannot log into Narcoreg. What do I need to do to be able to log in?
You can designate a principal access manager (PAM) using the exception procedure. To do so, follow the instructions in the user guide (§ 2.1.).

 

I can only select my previous employer's profile even though I now work for a different pharmacy. How to make the necessary changes?
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.

 

The address of my pharmacy is incorrect in Narcoreg. How can it be changed?

 

As a pharmacist, do I have to record only my drug purchases or also my sales (e.g., in case of a return to my wholesaler)?
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.

 

What if a pharmacist helps out another pharmacy?
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.

 

Do I also have to register my sales to patients?
No

 

What in case of a return from a pharmacy?
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.

 

As a pharmacy, we sell anaesthetics to veterinarians. Should this be recorded in Narcoreg?
No, neither party has to report that in Narcoreg. The order form is still used as was the case previously.

 

What is the procedure if pharmacies merge?
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.

 

 

3.    Specific questions and answers related to veterinary use

 

As a veterinarian, I buy anaesthetics from a pharmacy. Should this be recorded in Narcoreg?
No, neither party has to report that in Narcoreg. The order form is still used as was the case previously.

 

As a veterinary wholesaler, we purchase anaesthetics from veterinary manufacturers. Should this be recorded in Narcoreg?
Yes, the veterinary wholesaler records the purchase through Narcoreg, the veterinary manufacturer records the sale through Narcoreg.

 

As a veterinary wholesaler, we sell anaesthetics to pharmacists. Should this be recorded in Narcoreg?
Yes, the veterinary wholesaler records the sale through Narcoreg, the veterinarian records the purchase through Narcoreg.

 

As a veterinary wholesaler, we sell anaesthetics to other veterinary wholesalers. Should this be recorded in Narcoreg?
Yes, the purchasing wholesaler records the purchase through Narcoreg, the selling wholesaler records the sale through Narcoreg.

 

 

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