Circular 654 – Inspection on Full FMD Implementation

Circular 654 – Inspection on Full FMD Implementation

Belgium As previously announced, since 9th of Feb 2024, Belgium and Luxembourg switched to a full EU-FMD implementation. The Belgian NCA (FAGG / AFMPS / FAMHP) now published Circular 654 for the attention of the inspectors involved in the control of the distribution...
Webinar Full FMD implementation

Webinar Full FMD implementation

Belgium The Belgian “National Medicines Verification System” (NMVS) is linked to the “European Alert Management System” (EAMS) via a “National Alert Management System” (NAMS) since 1 July 2023. Since there is now the possibility of...
Serialisation: New Guidance for EU Inspectors

Serialisation: New Guidance for EU Inspectors

Europe The European Commission has published an Aide-Memoire to help both manufacturers and inspectors to verify compliance with the FMD regulation. Questions listed in the document focus for example on: Connection with hub and On-Boarding Partner (OBP) Data Flow...