The EU-Commission has fundamentally revised the EU Codex for Medicinal Products in its Pharmaceutical Package presented in December 2008. The focus lies on informations for patients, the protection against falsified medical products and the monitoring of authorised medical products (pharmacovigilance). For the latter, essential improvements are the obligation for an implementation of a risk-management-system for all newly authorised medical products and the option for authorities to impose requirements even after authorisation.
The proposed amendments are basically useful and necessary to improve the pharmacovigilance. However, details should be amended especially concerning the definition of the term “adverse reaction” and the newly introduced “essential information”.