EudraGMDP – Public Layout: Overview and Purpose

Cream Ointment Manufacturer in Vapi, Gujarat
Cream Ointment Manufacturer in Vapi, Gujarat

EudraGMDP (European Union Drug Regulating Authorities – Good Manufacturing and Distribution Practices) is a centralized database developed by the European Medicines Agency (EMA) to maintain transparency and streamline access to compliance-related information on Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) within the EU. It was established as mandated under Article 111(6) of Directive 2001/83/EC and Article 91 of Regulation (EU) 2019/6 to facilitate regulatory oversight and ensure pharmaceutical quality standards across member states.

The database serves as a critical resource for manufacturers, distributors, regulators, and the public, providing comprehensive information on manufacturers and distributors of medicinal products and active pharmaceutical ingredients (APIs) operating in the European Economic Area (EEA) and beyond.


Key Components of EudraGMDP

EudraGMDP consists of three main sections:

  1. GMP Certificates:
    • Lists certificates issued by national regulatory authorities to manufacturing and importation sites following successful GMP inspections.
    • Confirms compliance with EU GMP requirements, ensuring quality and safety in production.
  2. GMP Non-Compliance Reports:
    • Includes details of facilities found non-compliant with EU GMP standards during inspections.
    • Allows stakeholders to identify and address risks associated with non-compliant facilities.
  3. GDP Certificates:
    • Covers certification of compliance with GDP for wholesale distribution activities, ensuring proper storage, handling, and distribution of medicinal products.
  4. GDP Non-Compliance Reports:
    • Highlights cases of distributors failing to meet GDP standards, enhancing supply chain transparency.
  5. Manufacturing and Importation Authorizations (MIA):
    • Provides records of companies authorized to manufacture or import medicinal products under EU regulations.
  6. API Registrations:
    • Lists facilities registered for manufacturing or importing active pharmaceutical ingredients, as required by Directive 2001/83/EC.

Public Layout of EudraGMDP

The Public Layout is the publicly accessible section of EudraGMDP, offering open access to key regulatory information without requiring user authentication. It ensures transparency and supports stakeholders such as:

  • Regulatory Authorities: For verification and decision-making.
  • Healthcare Professionals: Ensuring compliance in supply chains.
  • Patients and the Public: Promoting confidence in the quality and safety of medicines.

Features and Navigation

  1. Search Functionality:
    • Users can search for specific entities using filters like:
      • Name of the company or facility.
      • Country or region.
      • Certificate type (e.g., GMP or GDP).
      • Product category (medicinal products or APIs).
    • Advanced search options provide greater specificity for locating records.
  2. Real-Time Updates:
    • The database is continuously updated with new certifications, authorizations, and compliance reports, ensuring stakeholders have the latest information.
  3. Export Options:
    • Information can be downloaded for offline review, aiding stakeholders in compliance verification and planning.

Importance of EudraGMDP

  1. Regulatory Oversight:
    • EudraGMDP supports regulatory bodies in maintaining a harmonized framework across the EU for pharmaceutical quality assurance.
  2. Transparency and Trust:
    • Public access to compliance data fosters trust in the pharmaceutical supply chain and informs decision-making by stakeholders.
  3. Facilitating Trade:
    • By centralizing compliance data, EudraGMDP simplifies the due diligence process for pharmaceutical companies engaging in cross-border trade.
  4. Risk Mitigation:
    • Identifying non-compliant facilities reduces risks associated with substandard or counterfeit products entering the supply chain.

Regulatory Mandates and Legal Framework

  • Directive 2001/83/EC: Governs medicinal products for human use within the EU, emphasizing the need for GMP compliance and regulatory oversight.
  • Regulation (EU) 2019/6: Focuses on veterinary medicinal products, extending the scope of EudraGMDP to include manufacturing and distribution compliance for animal health products.

Both legal frameworks underline the importance of EudraGMDP in ensuring high standards of safety, efficacy, and quality in pharmaceutical production and distribution.


The EudraGMDP Public Layout is a cornerstone of the EU’s commitment to pharmaceutical transparency and safety. By providing open access to GMP and GDP compliance data, it enables stakeholders to make informed decisions, supports regulatory harmonization, and safeguards public health across Europe. Its integration into the broader EU regulatory ecosystem ensures the continuous improvement of pharmaceutical quality standards, benefiting patients and industries alike.