Based on the FAMHP note of August 2019, the alerts are currently not an obstacle to delivering or distributing the products. However, pharmaceutical companies must be prepared when FAMHP decides to fully apply the FMD principles, namely that in the case of an alert, the pack must be kept for further investigation.
In addition, the FAMHP has in March 2022 made known its intention to visit companies for unannounced FMD audits.
medAspis takes a lot of work out of the pharm. operation all the work. Nevertheless, the company is fully GxP-compliant.