EudraGMP | European Database on Manufacturing and Import Authorizations and GMP

European database on Manufacturing and GMP authorisations

EudraGMP is a public database managed by the EMA. It lists manufacturing and import authorisations as well as Good Manufacturing Practice (GMP) compliance certificates.

It is a key tool for transparency and quality control, enabling authorities and industry partners to verify the compliance of pharmaceutical manufacturing sites.

EudraGMP, part of the broader EudraGMDP database, is the official European database that lists Manufacturing and Import Authorisations (MIA/IMAs) and Good Manufacturing Practice (GMP) certificates issued by EU regulatory authorities.

It is maintained by the European Medicines Agency (EMA) and used by EU Member States, the European Commission, and other regulatory partners to ensure transparency, oversight, and harmonised GMP compliance across the European pharmaceutical system.

EudraGMDP is accessible to the public, although certain regulatory fields remain restricted for competent authorities.

EudraGMP/EudraGMDP supports regulatory control and industry compliance by providing a centralised view of:

• Manufacturing and import authorisations for medicinal products and active substances
• GMP certificates issued after inspections
• Statements of non-compliance with GMP
• Registrations of active substance manufacturers and importers
  

This database improves transparency, facilitates inspections, and helps ensure the quality and safety of medicines circulating in the EU.

EudraGMDP contains several interconnected modules:

1. Manufacturing and Import Authorisations (MIA/IMA): records authorisations granted to companies that manufacture, import, or certify medicinal products for the EU market.
2. GMP Certificates: lists sites that have been inspected and found compliant with EU GMP requirements. Certificates detail the scope of manufacturing activities (e.g., sterile products, biologics, APIs).
3. Statements of Non-Compliance: published when an inspected facility fails to meet GMP standards. These notices inform regulators, industry, and supply chain partners of significant compliance concerns.
4. Active Substance Registrations: includes information on manufacturers, importers, and distributors registered under EU obligations for active substances (API) used in medicinal products.

The database is widely consulted by:

• Regulatory authorities conducting inspections or reviewing applications
• Pharmaceutical companies verifying supplier compliance
• Qualified Persons (QPs) assessing GMP status before batch certification
• Supply chain and quality teams ensuring traceability and regulatory conformity

EudraGMP plays a crucial role in safeguarding public health by:

• Ensuring that manufacturing sites meet EU GMP standards
• Providing transparency on compliance status for European and international partners
• Supporting regulatory decision-making for inspections, approvals, and variations
• Facilitating cooperation between Member States and third-country authorities

It is a foundational tool for maintaining the integrity of the EU’s pharmaceutical manufacturing and supply chain.