EU Good Distribution Practice (GDP) Guidelines: Key Requirements for Wholesalers

The latest EU GDP guidelines (Version 8) outline requirements for obtaining a Wholesale Distribution Authorizations (WDA) and ensuring compliance with Good Distribution Practices (GDP) for human medicines in the EEA.

Key Points:

• Storage & Transport: Medicines must be stored and transported under controlled conditions, with temperature mapping, logger calibration, and monitoring based on risk assessments.
• Compliance & Penalties: Non-compliance can lead to warnings, fines, or license withdrawal.
• Mediators: Must follow a quality system but cannot own medicines.
• Transport Rules: Storage under 72 hours does not require a WDA, but GDP compliance is mandatory.
  Licensing & Certification: A Wholesale Distribution Licence is required for certain activities, and a GDP certificate confirms compliance.
• Regulatory Oversight: Safety features on medicines are required under the Falsified Medicines Directive.
• Applications and license modifications must be submitted via the Farmatec website.

Region: European Union

Source: https://www.igj.nl/binaries/igj/documenten/publicaties/2017/06/20/vragen-over-de-eu-richtsnoer-goede-distributiepraktijken-gdp/FAQ+GDP-GNM+versie+8.0.pdf