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Slovakia FMD Management
Incident Portal
Guideline Version 1.0
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Content
Content ............................................................................................................................ 2
Introduction ...................................................................................................................... 3
Log in to the Incident Management Portal (IMP) ............................................................... 4
List of associated incidents ................................................................................................ 5
Incident Resolution ........................................................................................................... 8
Resolve one incident separately ........................................................................................ 8
Resolve group of incidents in one action ......................................................................... 11
Incident handling process ................................................................................................ 14
Important information .................................................................................................... 16
Contact information ................................................................................................................... 16
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Introduction
The Slovakia FMD Incident Management Portal (IMP) is intended for registered companies
that have contracts with Slovak medicines verification organization - SOOL and represent
individual MAHs uploading data to SK-NMVS.
The main purpose of the IMP is to provide the company with an up-to-date overview of all
assigned MAH incidents that the company represent. At the same time, this portal is a
transparent tool that will enable the company to respond quickly and easily to incidents within
its scope.
In the event of an incident, the system assigns the MAH to the incident based on the product
code to which the MAH will be assigned in the database and subsequently the company that
represents the MAH. Each company relevant incident will be entered in the incident list of the
company. Contact persons responsible for incidents for individual MAHs will continue to
receive information about the incident via email.
This guideline describes the basic principles, how to work with IMP from MAH perspective.
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Log in to the Incident Management Portal (IMP)
Access to the portal will be generated and sent to contact persons who are registered on the
MAH portals and represent the company in communication with SOOL (the login name and
the password).
After receiving the access credentials, it is up to the contact person (company) who will be
responsible for working on the portal. Several people can also use the portal. However,
coordination in incident management is essential.
After receiving the access credentials, it is up to the contact person (company) who will be
responsible for working on the portal. Several people can also use the portal but with the same
credentials. For this case, coordination in incident management portal is essential.
Login to IMP using the credentials you can through this link: https://mah.sk-nmvs.sk/
If you have not received the email with the credentials for the IMP and have signed a contract
with SOOL, please send the request to SOOL ( [email protected])
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List of associated incidents
After successfully logging into the Incident Management Portal - IMP, the user has an overview
of all incidents assigned to his/her MAH(s).
To display the subset of all incidents, the user can choose from several filters:
1. According to the current state of the incident:
• WAITTING FOR END USER
- Subset of incidents, where the action is pending on the end user.
• WAITTING FOR NCA
- Subset of incidents, where the action is pending on the NCA.
• WAITING FOR MAH
- Subset of incidents, where the action is pending on the MAH themselves.
• WAITING FOR SOOL
- Subset of incidents, where the action is pending on the SOOL (Slovakia NMVO).
• OPEN
- Subset of incidents where one or more users responded already to the incident (SOOL, End
User, NCA) and action is pending on the MAH.
• CLOSED
- Subset of closed incidents, no action is needed
2. According different parameters defined in the filter:
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• MAH
- If the company represents more MAH you can filter out each separately.
• Date & Time
- You can choose the time period From – To, when the incidents occurred in the system.
• Product code
- Filter by specific product number.
• Batch
- Filter by specific Batch.
• Return code EU HUB
- Filter by return code generated by EU HUB.
• Return code SK-NMVS
- Filter by return code generated by SK-NMVS (ARVATO BPS).
When you specify parameters of the filter, press the SEARCH button to display filtered
incidents.
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List of incidents according to selected parameters
The following columns appear in the list:
▪ Internal ID – a unique incident number assigned by the IMP;
▪ Date & Time – date and time when the incident occurred in SK-NMVS.
▪ Product Code – the product number of the pack associated with the incident;
▪ Name – name of the product associated with the incident;
▪ Batch – the batch of the product associated with the incident;
▪ SerialNumber – the serial number of the pack associated with the incident.
▪ Return Code SK-NMVS – incident return code generated by SK-NMVS (Arvato BP
system return code);
▪ Return Code EU HUB – incident return code generated by EU HUB.
▪ Description – a description of the incident
▪ Incident ID – a unique incident ID generated by SK-NMVS (ARVATO BPS);
▪ Status – the status of the incident (according to IMP).
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Incident Resolution
Incidents can be actioned separately or in the group:
Resolve one incident separately
In the list of incidents, click on Internal-ID (see red arrow below) to open the details of the
incident.
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Then the incident details appear on the screen and the user will see:
Detailed information about the incident (top section).
- Alert ID, Create date, Description, MAH name, PC, Batch, Expiry date, SN, Close date.
In the middle section "Solutions" – user can see a comment that was written by any user of
IMP in the previous action related to this incident.
At the bottom section "Solve the incident" are options how to react on the incident. It contain
following subsections:
- NOTE text box can be used by the user to write a note related to the incident and related to
his/her response to the incident. This note is optional except the situation, when the user
would like to react on the incident with the option 5. (see below) where the user requests
some info from incident initiator (pharmacy, wholesaler).
- Choose options – in this subsection user can react on incident by pressing one of the
offered buttons (see description below):
1. Technical Incident ... the pack was upload in the register. It can be dispensed to the
patient.
- Through this option user inform initiator of incident, that the pack associated with incident
was uploaded in the register and can be dispensed to the patient.
2. Technical Incident … the pack was NOT uploaded due to technical reasons. It can be
dispensed to the patient.
- Through this option user inform initiator of incident, that the incident relevant pack was
NOT and will NOT be uploaded in the register due to technical reasons but can be dispensed
to the patient.
3. Suspicious falsification ... the pack of the medicine must NOT be dispensed to the
patient!
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- Through this option user inform initiator of incident, that the incident relevant pack must
NOT be dispensed to the patient because it is suspicion falsify pack!
4. Unresolved ... the MAH needs more time to investigate the incident.
- Through this option user inform the initiator of incident, that the MAH needs more time
to investigate the incident.
5. Unresolved ... the MAH needs more information from the End user.
- through this option user inform the initiator of the incident, that the MAH needs more
information from the End user side about the pack related to the incident. In this case detail
description of needed information is mandatory and field “NOTE” must be used for this.
1.
To confirm selected option confirmation request box will appear on the screen and user must
press “YES” button to save the selected option. This operation is irreversible, and user can’t
undo this step.
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Resolve group of incidents in one action
From the list of incidents, you can use the checkbox to select all incidents that the user wants
to work with (see blue arrows 1. below.).
In case you want to select resp. to deselect all incidents, it is possible to use the main checkbox
„Check/Uncheck ALL“ (see blue arrow 2. on screen above).
After clicking on the "Bulk update" button, you will see a screen for mass incident handling
(see blue arrow 3. on screen above).
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Screen for BULLK UPDATE
The user can additionally modify the list of incidents that wants to resolve in this step using the
checkboxes closed to incidents (see red arrow 1.).
- NOTE text box (see red arrow 2.) can be used by the user to write a note related to the all
chosen incidents and related to his/her response to this group of incidents. This note is
optional except the situation, when the user would like to react on the selected group of
incidents with the option 5. (see below) where the user requests some info from the incident’s
initiators (pharmacy, wholesaler)
-Choose options – (see red arrow 3.) in this subsection user can react on the selected group
of incidents by pressing one of the offered buttons (see description below) So all selected
incidents will be actioned trough the same option. Options are:
1. Technical Incident ... the pack was upload in the register. It can be dispensed to the
patient.
- Through this option user inform initiator of incident, that the pack associated with incident
was uploaded in the register and can be dispensed to the patient.
2. Technical Incident … the pack was NOT uploaded due to technical reasons. It can be
dispensed to the patient.
- Through this option user inform initiator of incident, that the incident relevant pack was
NOT and will NOT be uploaded in the register due to technical reasons but can be dispensed
to the patient
3. Suspicious falsification ... the pack of the medicine must NOT be dispensed to the
patient!
- Through this option user inform initiator of incident, that the incident relevant pack must
NOT be dispensed to the patient because it is suspicion falsify pack!
4. Unresolved ... the MAH needs more time to investigate the incident.
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- Through this option user inform initiator of incident, that the MAH needs more time to
investigate the incident.
5. Unresolved ... the MAH needs more information from the End user.
- through this option user inform initiator of incident, that the MAH needs more information
from the End user about pack related to incident. In this case detail description of needed
information is mandatory and field “NOTE” must be used for this.
To confirm selected option the confirmation request box will appear on the screen and user has
to press “YES” button to save the selected option. This operation is irreversible, and user can’t
undo this step.
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Incident handling process
Below is schematic process, how to handle the incident, which was caused by missing
relevant data in NMVS by IMP.
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Below is schematic process, how to handle the incident, which was caused by non-active status
of pack UI in NMVS by IMP
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Important information
In order to properly understand the operation of this portal, it is necessary to familiarize yourself
with the current process, which is published on the website www.sool.sk in the section
management-incidents.
We welcome all your comments and insights to help us improve this portal. We will try to
improve it gradually to become useful tool for incident management.
Contact information
Slovak Medicines Verification Organization – SOOL
Address: Einsteinova 11, 851 01 Bratislava – Slovak republic
Email: [email protected]
