GDP Compliance Certificate for Distributors of Active Substances

“This document is the official template for the Good Distribution Practice (GDP) certificate, applicable to distributors of active substances used in medicinal products. Key points include:

1. Certificate Details: Includes certificate number, page number, and distributor’s name and address.
2. Inspection Compliance: Confirms compliance with Article 111 of Directive 2001/83/EC and/or national legislation, based on the most recent inspection.
3. Validity: The certificate is valid for five years from the inspection date, unless stated otherwise in the Restrictions or Clarifying Remarks section.
4. Verification: Authenticity can be verified through EudraGMDP, with contact details for the issuing authority.
5. Restrictions/Clarifying Remarks: Includes any additional limitations or specific details related to the certificate’s scope.”

Source:https://www.ema.europa.eu/en/documents/template-form/union-format-good-distribution-practice-gdp-certificate-active-substances-be-used-starting-materials-medicinal-products_en.pdf##~https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-manufacturing-practice/compilation-union-procedures-inspections-exchange-information

Region: EEA (30 Markets), EU Harmonized (27 Markets)