medAspis Alert Guard – Guideline for Dutch NMVO
A critical alert occurs and is reported.
A critical message is displayed, a Unique Alert ID is generated, Dutch NMVO, IGJ and the affected manufacturer are automatically informed.
- In order not to risk the supply of medicinal products, the pharmaceutical company may first assess whether the pack is possibly a falsification.
- If the pharmaceutical company has no reason to believe that the packaging could be falsification, the pack may be dispensed.
- If something looks wrong, the pack must not be dispensed and must be reported to the IGJ.
If an error in uploading the codes is suspected, it is better to contact the manufacturer first.
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, IJG receives data access to every critical alert. Differences between alerts registered at Dutch NMVO and those reported and processed by the company itself can be immediately detected.
Diagram of the process flow with medAspis
medAspis takes a lot of work out of the pharm. operation all the work. Nevertheless, the company is fully GxP-compliant.
