Handling of alerts and exceptions

e-VIS has developed Recommendations for handling exceptions and alerts from Swedish NMVS (e-VIS rekommendationer för hantering av varningar och alerts från SMVS).

The recommendations descibes how end-users should handle and investigate packs that have caused alerts or other warnings from the Swedish NMVS (National Medicines Verification System) and how MAHs should investigate the alerts and exceptions. For MAH the e-VIS recommendations complement EMVO Best Practice on Alert Handling.

• The recommendations shall serve as a basis for the parties concerned to draw up internal procedures and SOPs from.
• The recommendations are found in Swedish on the Swedish part of www.e-vis.se
• A translation of the document to English is under production and will be published soon.

Please reach out to e-VIS in case of any questions.

Mock exercise in the alert management process

An alert management exercise for Swedish stakeholders was arranged by e-VIS in November 2021. The value of performing mock exercises was identified following dialogue with the Medical Products Agency. The purpose of performing this kind of exercise is:

• To show the importance of sharing information between stakeholders and to improve associated processes
• To increase e-VIS and all stakeholder preparedness
• To rehearse and learn from each other within the EMVS community as a real situation with a confirmed falsification will be rare

Report from the Mock Exercise 12 November 2021