Tag: Eudralex

Enacted on November 6, 2001, Directive 2001/83/EC consolidated three decades of pharmaceutical legislation into the single, foundational European Union law regulating medicinal products for human use. This directive ensures high standards of safety and quality for all medications sold within the EU's internal market.

In July 2012, new EU pharmacovigilance legislation was implemented, triggering the replacement of EudraLex Volume 9A with the comprehensive Good Pharmacovigilance Practices (GVP) guidelines. This significant shift in medication safety and pharmacovigilance marked an evolution in regulatory standards for the pharmaceutical industry across Europe.

Established in the early 1990s to harmonize pharmaceutical oversight, EudraLex is the official compilation of rules governing medicinal products within the European Union (EU). This extensive collection of legislation and guidelines is mandatory for any company seeking market access in the EU pharmaceutical ecosystem, ensuring products meet stringent safety, efficacy, and quality standards.