The EudraGMDP database is the European Union's, maintained by the European Medicines Agency (EMA), containing information on manufacturing authorizations, Good Manufacturing Practice (GMP) certificates, and Good Distribution Practice (GDP) compliance for medicinal products. It centralizes data on authorized manufacturers, importers, and wholesalers, providing public access to verify the compliance status of pharmaceutical companies operating in the EEA.
Key details about the EudraGMDP database include:
Content: Contains GMP certificates, manufacturing/import authorizations (MIA), Good Distribution Practice (GDP) certificates, statements of non-compliance, and registration of active substance manufacturers.
Managed by: The EMA, in partnership with National Competent Authorities (NCAs) of the European Economic Area (EEA), which populate the database.
Purpose: Enables inspectors, regulatory bodies, and industry stakeholders (such as Qualified Persons) to verify compliance, track inspections, and ensure supply chain integrity.
Public Access: Almost all information is public, except for commercially sensitive data or inspection planning details.
Scope: Covers human and veterinary medicines and includes information EU and EEA ries, along with some international compliance data.
