medAspis Alert Guard – Guideline for France MVO
A critical alert occurs and is reported.
A critical message is displayed, a Unique Alert ID is generated, France MVO and the manufacturer are automatically informed.
- The medicine pack must be separated until a case of falsification has been excluded.
- France MVO must be informed immediately via a predefined e-mail form to info@france-mvo.fr. A photo of the pack with 2D code and the readable text should be attached. Please use this excel-sheet to report the alert.
Examination of the suspected counterfeit case by France MVO
France MVO operates an alert monitoring process on a weekly basis. Every Monday, all alerts from the previous week are analysed.
- From the weekly data, those players who are responsible for the most alerts are identified and contacted immediately.
- At the same time, France MVO takes care of pharmaceutical companies that submit investigation requests.
- If additional information is needed, the pharmaceutical company or the manufacturer will be contacted.
- Within 24 hours (excluding weekends and public holidays), the pharmacy should receive a response. The pharmaceutical company should receive a reply so that the quarantine can be lifted as soon as possible.
Diagram of the process flow
Procedure without medAspis
The area with a grey background is the part of the process chain visible to the pharmaceutical company. However, GIF receives data access to every critical alert. Differences between alerts registered at France MVO and those reported and processed by the company itself can be immediately detected.
Diagram of the process flow with medAspis
medAspis takes all the work out of the pharm. operation all the work. Nevertheless, the company is fully GxP-compliant.
