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...

New report form for falsified medicines

The Netherlands Since February, all prescription medicines have a unique code and sealed packaging. The purpose of these safety features is to detect counterfeit medicines in the regular distribution channel. Any problem with the code or the seal can be reported...