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Incident types for this category:<\/p>\n
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– The end user scans the 2D code on the pack; – The Incident is recorded on the Incident Management Portal – IMP; – In the event that the MAH marks option 1 or 2, the incident shall be closed and transferred to the archive after End user is\u00a0acknowledgment of the outcome of the investigation; <\/p>\n * Each procedure may vary and may not always be the same as above.<\/em><\/p>\n","protected":false},"excerpt":{"rendered":" Process for incident category – NOT UPLOAD DATA Incident types for this category: DIAGRAM STANDARD PROCESS: – The end user scans the 2D code on the pack; – The software sends the data for verification to the verification system – SK-NMVS; – The verification system checks all 2D code parameters (Product […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-761","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"\n
\n– The software sends the data for verification to the verification system – SK-NMVS;
\n– The verification system checks all 2D code parameters (Product Code, Serial Number, Batch, Expiration) and pack\u00a0status;
\n– If any parameter is incorrect or the combination of parameters is incorrect, the system returns a negative response;
\n– The end-user\u00a0software displays a warning message;
\n– Despite a negative response from the verification system, the pharmacist can dispense the package to the patient (only for category of incidents ,,Not Upload Data<\/strong>”\u00a0– see above Important Information).
\n– The verification system automatically generates the incident and assigns it a\u00a0unique identification number =\u00a0Alert ID;
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\nSUBSEQUENTLY
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\n– The incident is displayed both at the MAH and at the end user;
\n– The incident has the status: ,,Watting for MAH<\/strong>”\u00a0and the end user who created the incident will see the incident in the incident list in the section: ,,Waiting for MAH\u00a0or NCA<\/strong>“;
\n– In this type of incident, the first response from the MAH is needed and therefore only the MAH can actively intervene in the incident and choose some way to proceed with the pack of the medicine;
\n– The MAHhas a choice of 5 options:
\n-><\/strong>\u00a01.\u00a0<\/strong>Technical Incident<\/b>\u00a0… the pack was upload in the register. It can be dispensed to the patient.
\n->\u00a02.\u00a0<\/strong>Technical Incident<\/b>\u00a0\u2026 the pack was NOT uploaded due to technical reasons.\u00a0 It can be dispensed to the patient.
\n– this option should only be used when necessary. Because there may be duplication of incidents. (the pharmacist recalls the incident when re-dispensing). The medicine pack must be upload in the verification system, otherwise the law is violated.
\n->\u00a03.\u00a0<\/strong>Suspicious falsification<\/b>\u00a0… the pack of the medicine must NOT be dispensed to the patient!
\n– after you specify this option, the incident will automatically be sent to NCA for investigation. You should use this option when there is a seriously\u00a0suspicion of falsification (not if your analysis reveals a probable problem with the scanner or wrong pairing of 2D code).
\n->\u00a04.\u00a0<\/strong>Unresolved<\/b>\u00a0… the MAH needs more time to investigate the incident.
\n– if the investigation of the incident requires more time on your part, it is necessary to inform the end user that you are dealing with the incident but need more than 48 hours. Entering this option will extend the time by 48 hours.
\n->\u00a05.\u00a0<\/strong>Unresolved<\/b>\u00a0– The MAH needs more information from end user.
\n–\u00a0for this option, it is necessary to fill in a note stating what information you require from the end user. Until 31\/08\/2020, please do not request a photo of pack from the end user.
\n-> 6.\u00a0Technical incident<\/strong>\u00a0– end user scanner issue, the scanner misinterprets information contained in pack’s 2D code. End user is requested to configure the scanner properly.
\n– If the MAH\u00b4s analyses reveals that the alerts probably triggered by a wrong configuration of the scanner or the software used for the verification of that pack. The MAH should use this option.\u00a0\u00a0It is possible to add a note for better explanation (not mandatory).\u00a0 This findings will help to identify and correct these cases.<\/p>\n
\n– In the event that the MAH marks option number 3, the incident will be transferred to the NCA. The NCA will open an investigation and issue an official statement after the investigation.\u00a0All parties concerned are informed (manufacturer and end user, SOOL);
\n– In the event that the MAH marks option number 4, only the time has been extended by another 48 hours\u00a0but still we waiting for the MAH\u00b4s response;
\n– In the event that the MAH marks option number 5, then the incident is moved to the end user and awaiting on End User\u00b4s response.\u00a0The MAH shall request more information from the end-user therefore it is necessary to be by writing in the note what information are requires. Note is required for this option. End-user adds information to the incident with a note or can upload a file (image) . Once the end user adds a note or uploaded file, the incident is moved back to the MAH. The MAH will in turn have a choice of one of five options again.<\/p>\n