System notifications and alerts

Different types of transaction errors in the medicines verification system can generate various system notifications. These notifications are categorized into 5 levels, and only the highest level, L5, generates alert that require an alert investigation. 

A medicine’s pack that has generated an alert should not be sold or used by a patient. When the verification system generates an alert, both the end user and the Marketing Authorisation Holder (MAH) should initiate a simultaneous investigation. 

The end user performs the following actions:

• the medicine’s pack must be quarantined/ withhold pack from saleable stock until the cause of the alert is resolved,
• make sure that the cause of the alert is not a technical, procedural, or manual error,
• if the alert is not identified on the end user's side, then the investigation of the alert should be started by contacting the marketing authorisation holder (MAH),
• the marketing authorisation holder, the Latvian Medicines Verification Organisation or the Health Inspectorate may request a photo of the medicine pack that caused the alert for further investigation,
• the alert and its investigation must be documented,
• if necessary, the end user can ask for the support of the Latvian Medicines Verification Organisation and/or the Health Inspectorate.

Currently LZVO is not affiliated to any of Alert Management System (AMS) and its implementation has not yet been decided. Therefore, MAH’s are kindly asked to continue communication regarding alerts via e-mail.

MAH investigates the alert by performing the following steps:

• if any error related to data upload, MAH takes corrective actions,
• if any error in the EU Hub, OBP/MAH takes appropriate actions,
• if the cause of alert is unclear, MAH can request LZVO a photo of the pack,
• MAH investigates all alerts, however contacts LZVO only if is clear that alert is generated by end user in Latvia (not in any other market) and if MAH has a reasonable suspicion to consider alert as potential falsification.

For more effective cooperation, while sending LZVO questions about alerts or alert reports, MAH is kindly asked to provide LZVO with the details listed below:

Regarding the alert (L5 level errors) LZVO follows the EMVO procedure: “Best Practice on Alert Handling” Guideline”, please follow the link: https://emvo-medicines.eu/new/wp-content/uploads/Best-Practice-on-Alert-Handling.docx.pdf