CONNECTING USERS TO THE VERIFICATION SYSTEM
Their software supplier or in-house IT department must develop and implement a connection module to the NMVS. The first step is to connect to the development portal (sandbox): www.sws-nmvs.eu
The different steps are:
Development Portal (Sandbox)
connect & register to https://www.sws-nmvs.eu/
• All general and technical documentation to develop the interface;
• Test data to assist in the development;
• Baseline testing going to the next step and receive the connection
endpoints
IQE Environment (recommended)
This environment is close to the live PROD system & allows testing the actual implementation
with a dummy end-user.
More specific, it allows also to test other functions than the transaction processes, such as:
• Password renewal
• Certificate implementation
• Acceptance of T & C
Contact BeMVO for access
PROD environment
The live NMVS environment connected to the EU Hub.
The endpoints to connect users to the PROD NMVS are communicated
after having succeeded in the baseline testing.
FUNCTIONALITIES FOR END-USERS
In this case, the status of the pack is changed and set to ‘Inactive’ or reset to ‘Active’ in case of an ‘Undo’. Be aware that for the transaction types ‘Destroy’ and ‘Stolen’ the undo is not possible. It is recommended to add a confirmation step for the user to execute such a transaction. Furthermore, wholesalers can run a ‘Homogeneous Bulk’ and pharmacies a ‘Mixed Bulk’ transaction.
The ability to download the Product Master Data file at any time for a selection of packaging codes or for all codes. This extract contains for each product code the ‘Designated Wholesalers’ (who distribute on behalf of the MAH) and the MAH. If the licence holder has entered the national code (CNK), this information is also provided (note: this is the information entered by the licence holder).
A series of processes to manage the end-user’s connection: password renewal (required every 90 days), certificate renewal (every 2 years) and T&C acceptance (mandatory).
The ability of the end-user to connect to the NMVS via an internet browser in case of emergency due to technical problems. This requires the installation of the certificate in the browser.
END-USER INTERACTIONS WITH THE NMVS
When a transaction is submitted to the NMVS, the NMVS will send a return code and a description, to indicate whether the transaction was processed successfully or if a problem occurred.
Consult the full list of return codes, what the cause may be and what to do here: Return Codes – Release300 – IF5
Some of these return codes indicate that the verified or decommissioned pack is a possible falsification. The process to follow in case of a possible falsification can be found on the NAMS page
From a software perspective, it is crucial that the user is clearly informed about the generated alerts. A traceable file (log file) must keep track of all transactions and alerts generated. Especially, the alert ID is needed to trace the information about the concerned package if the user is contacted by BeMVO or by the competent authorities when the alert would have been escalated to them.
MOST COMMON 'TECHNICAL' CAUSES FOR FALSE ALERTS
If the end-user’s scanner is provided by its software vendor, the software vendor must ensure that it is correctly configured and remains in that state.
A typical issue is that the scanner is configured for QWERTY or German keyboard, whereas the user uses an AZERTY keyboard. Another cause can be that the scanner does not correctly read the GS-1 separator and that different data elements are concatenated together.
The (correctly) scanned information should be used as such to construct the transaction to be sent to the verification system. It should be avoided that the data elements received from the scanner are transformed based on any internal software logic.
It still occurs that some transactions are running into a loop whereby the same transaction is re-sent to the verification system every x minutes.
Besides these causes, there are also the process errors made by the end users, e.g., multiple decommissioning of the same packs.
PROBLEM SHOOTING
USER CANNOT PERFORM THE VERIFICATION/TRANSACTION
There are several reasons why the user cannot perform verifications. Generally, the reason can be identified from the return code the user receives when he tries to perform a transaction.
In these cases, where the user cannot establish a valid connection to the NMVS or cannot immediately resolve the technical problem that prevents him from performing the verification, he can still continue to distribute and deliver the package.
In that case, however, the transactions carried out must be stored in the user’s system and submitted to the NMVS when the connection is restored (art. 29 D.R.).
USER HAS NO CONNECTION OR CERTAIN TRANSACTIONS ARE REJECTED
The user receives a notification 10 days before the password expires.
If the password is not changed, the user account will be blocked after 3 connections with the wrong password.
SOLUTION
Option A
BeMVO unlocks the user account. The user must first run the password change before any other (3) transactions, otherwise the user account will be locked again.
Option B
Ask BeMVO to unlock and to receive a new password.
Note that the new password must be processed as a new ‘initial’ password. The first transaction to be performed is the G445 Password Change where the given password must be used as the ‘old’ password.
If the password is changed in any of the multiple systems that are not connected by the end-user, the other systems receive a notification that they must be updated with the changed password within 5 days.
If the password is not changed in time, the user will be blocked after 3 attempts.
SOLUTION
Option A
BeMVO unlocks the user.
The user must first change the password on that (those) system(s) before performing other (3) transactions, otherwise the useraccount will be locked again.
Option B
Ask BeMVO to unlock and receive a new password.
Note that the new password must be processed as a new ‘initial’ password. The first transaction to be performed is the G445 Password Change on all systems where the specified password is to be used as the ‘old’ password.
No certificate is installed in the user’s system or the certificate used has expired.
When the certificate is about to expire, the user will receive an e-mail with the link to the PKI server and the TAN code to download the certificate. From day 30, he will receive an e-mail every day.
If the certificate is not installed, the user account will be blocked.
SOLUTION
Download and install the new certificate if still available (before expiry of the current one).
Otherwise, contact BeMVO for a new certificate and download + install asap.
The end-user receives a notification when a new ‘mandatory’ version of the T&C must be accepted. If these are not accepted in time, transactions are not processed.
SOLUTION
Accept the T&C immediately. The version to be accepted is mentioned in the system response with process ID G482 (current version 6001).
These error codes indicate that the XML of the submitted web service is incorrect. The most common errors are:
- A mandatory field is empty
- The data in the field is invalid (e.g. invalid expiry date format)
- The field is too long (e.g. SN has more than 20 characters)
- The entry contains non-GS1 compliant characters
SOLUTION
The end-user’s software must validate these elements before the web service is submitted.
When the end-user receives the return code NMVS_TE_REQ_01, it indicates that the user is attempting an Intermarket Transaction (IMT), i.e. verification of a non-BE/LU package in another country’s system. The return code indicates that the EU Hub or other system did not respond in time.
SOLUTION
The user has to perform the transaction again at a later time.
Consult here the table with all return codes from the system and possible actions for the end-user and his FMD module:
VERIFICATION AND DECOMMISSIONING WEB SERVICE TRANSACTIONS
Process ID | Process | Pharmacy/ Hospital | Wholesaler | Undo Y/N | Comment |
G110 | Verify Single Pack | Y | Y | na | Verification can be done at any moment. |
G112 | Manual Verification Single Pack | Y | Y | na | Only to be used if pack cannot be scanned. Requires only PC and SN as input. |
G120 | Dispense Single Pack | Y | Y | Y | Reminder : Undo only possible within 10 days and by same user. |
G122 | Manual Dispense Single Pack | Y | Y | Y | Only to be used if pack cannot be scanned. Requires only PC and SN as input. |
G130 | Destroy Single Pack | Y | Y | N | No UNDO possible. Add safety by requesting (double) confirmation. |
G140 | Export Single Pack | N | Y | Y |
|
G150 | Sample Single Pack | Y | Y | Y |
|
G160 | Free Sample Single Pack | N | Y | Y |
|
G170 | Lock Single Pack | N | Y | Y |
|
G180 | Stolen Single Pack | N | Y | N | No UNDO possible. Add safety by requesting (double) confirmation. |
G115-G185 | Submit Homogeneous Bulk | N | Y | Undo possible for transactions where it is also possible for the Single Pack transaction. |
G188 | Request Bulk transaction result | N | Y | Be aware that a ‘Bulk’ transaction is not possible for non-BE/LU packs |
G195 | Submit Mixed Bulk | Y | N | Undo possible for transactions where it is also possible for the Single Pack transaction. |
G196 | Request Mixed Bulk result | Y | N | Be aware that a ‘Bulk’ transaction is not possible for non-BE/LU packs |
G101 | Download Master Data | Y | Y | This web service allows downloading the product master file from NMVS, containing all GTINS in the system, the Marketing Authorisation Holder having uploaded the Product Code and the national code uploaded by the MAH. |
USER MANAGEMENT
Process ID | Process | Comment |
G445 | Change password | This web service allows changing the password of the user. The password must be renewed every 90 days. |
G482 | Load Terms & Conditions | Download the T&C document from the NMVS. The NMVS response XML also contains the Version ID to be used for the Confirmation step (currently version 6001). |
G483 | Confirm Terms & Conditions | This web service allows the mandatory acceptance of the T&C. |
G615 | Download client certificate PKI | This web service allows downloading the certificate. Consult the documentation explaining the 2 ways to access and download/renew the certificate. |
GUI | Graphical User Interface | The verification, single pack transactions, password change and T&C confirmation is also possible for the user by accessing the NMVS with the GUI in the internet browser. To be able to access the NMVS with the GUI, the certificate needs to be installed in the browser. |
LIST OF SOFTWARESUPPLIERS
List of Software versions that have passed Baseline Testing and are ready for implementation of the connection to the LIVE environment of the National Medicines Verification System for End Users in Belgium and Luxembourg.
Update: January 2023
Company | Software | Version | Pharm.Single Transactions | Pharm.Bulk Transactions | WHS Single Transactions | WHS Bulk Transactions |
ADC NV | ADC-FMD | 1.0 | X | X | X | X |
ADENTS | ADENTS DISPAX | 0.5.0 | X | X | X | X |
ADHERTEC S.R.O. | NMVS.ONLINE | 1.00 | X | |||
ALN TECHNOLOGY LTD | FMDPLUS | 1.2 | X | X | X | X |
ARVATO SYSTEMS GMBH | ARVATO SMART LOGISTICS PLATFORMS – HEALTH CARE SUITE | 1.2 | X | X | X | |
BECTON DICKINSON AND COMPANY | BD PYXISTM FMD VERIFY | 1.0.0.0 | X | |||
C. CONSULT ADVICE | ADMED/PHARMA | 201501 | X | |||
CEGEDIM | HOSPITALIS | 3 | X | X | ||
CENTRE HOSPITALIER BOIS DE L’ABBAYE (CHBA) | CHBAPHA | 1.0 | X | X | ||
CENTRE SPECIALITES PHARMACEUTIQUE | CSPPRODUCT | 1.0 | X | X | X | |
CERP | NPI1 | 1.0 | X | X | X | X |
CHIPSOFT | CHIPSOFT HIX | 6 | X | |||
CHRH | GINET | 1.0 | X | |||
CORILUS | CARECONNECT PHARMACIST | 1.00.66 | X | |||
CPL | CPLWEB | 4.0.0 | X | X | ||
CVBA VOORUIT | VOORUIT PRODUCT | 1 | X | X | X | X |
DAXANT SA | CHECKFMD | 1.0.0 | X | X | ||
DEBISCOM BVBA | MERCATOR | V3 | X | |||
EASI SA | SOFT ADFINITY | 1.6 | X | X | X | X |
EPC FAMILIA | EPC | 02 | X | X | X | |
FARMAD | TWIN | BETA 2 | X | |||
FEBELCO | PDC FMD | 0.1 | X | X | ||
FRESENIUS NETCARE GMBH | SAP OER | 7 | X | |||
GOED ICT | VIANOVA (PHARMACY) -ESCAPO (WHOLESALER) | 20.9.2 | X | X | X | X |
H. ESSERS | H. ESSERS WMS | 5.8 | X | |||
HANFF GLOBAL HEALTH SOLUTIONS | HANFF | 1.0.0 | X | X | ||
INEO | MERCATOR | 1.0.0.0 | X | X | X | X |
INFOHOS | NMVS-CONNECTOR | 1.0 | X | X | ||
IPHARMA LOGISTIC | IPHARMA | 1.18 | X | |||
LOGIPHARM | LOGIPHARM | 1.105.0.1 | X | X | ||
MAUVE MAILORDER SOFTWARE GMBH | MAUVE SYSTEM 3 | 2020.2 FF | X | X | X | X |
MEDASPIS B.V. | MEDASPIS CONNECTOR PLUS (FOR PHARMACIES AND HOSPITALS) | 2018.08.27 | X | X | ||
MEDASPIS B.V. | MEDASPIS CONNECTOR PLUS (FOR WHOLESALERS) | 2018.08.27 | X | X | ||
MEDITECH | MTULTRAFICTUS | 1.0 | X | X | ||
MEDSOC | APOMEDSOC | 1 | X | X | X | X |
MMS-SOLUTIONS | YGLOBAL | 8.0 | X | X | X | X |
MOVILITAS | MOVILITAS.CLOUD-ARVATO CONNECTOR | 1.2.0 | X | X | X | X |
MULTIPHARMA SCRL | MULTIPHARMA-FMD | 2.0 | X | X | ||
NEWPHARMA | SOAP UI | 5.4.0 | X | X | ||
NEXTPHARM | NEXT | V22 | X | |||
OBASI | OBASI SOFTWARE | 1.0 | X | X | ||
OCP | PORTAIL | 1.0 | X | |||
OFFICINALL | OFFICINALL | 19 | X | |||
OPTIMA SYSTEMS | MEDTRACS | 1.0 | X | X | X | X |
PHARMABELGIUM-BELMEDIS | PHBFMD | 1.0 | X | X | ||
PHARMAGEST | FMD-ENGINE | 1.0.0 | X | X | ||
PHARMONY SA | PHARMONY ONE | 1.1.564 | X | X | X | X |
PROPHAC | PRONAV | 1 | X | X | X | X |
QUICK PHARM SOLUTIONS LIMITED | EASYFMD | 1.0.5.6 | X | X | X | X |
RFXCEL CORPORATION | RFXCEL TRACEABILITY SYSTEM (RTS) | 5.8.2 | X | X | X | X |
S.A. LOGAL | EVOLUTIVE COMPTA | 79 | X | X | ||
SAP | SAPICH | 2268 | X | X | X | X |
SBIM | GCLWIN | 1B40 | X | |||
TCK GMBH | NMVS CONNECT | 1.1 | X | X | X | X |
TRACELINK | TRACELINK LIFE SCIENCES CLOUD | 2018.5 | X | X | ||
TRACINGINMOTION BVBA | TRACFMD | 1.0 | X | X | ||
UZ ANTWERPEN | UZA ZIS-APOTHEEK | 9.7 | X | X | ||
UZ LEUVEN | UZL-DUMMY2 | 1.0 | X | |||
VPHARMA | VPHARMA | 1.0 | X | X | X | X |
VZW NETWERK HIERONYMUS | DIBROSI INFORMATIE SYSTEEM | 1.0 | X | X | ||
Wininfo | WininfoNMVS | 1.0.0.0. | X | |||
XPERTHIS | XPERTHISFMD | 0.1 | X | X | ||
ZETES UK LTD. | ZETESOLYMPUSFMD | 1.0.0 | X | X | X | X |
IMPORTANT INFORMATION CONCERNING THE URGENT IMPLEMENTATION OF THE USER INTERFACE VERSION 5.
It is mandatory to switch to interface V5 by October 2023
You can find info in this document
