EudraGMP greatly improves the sharing of information and coordination of action in the area of authorisations and GMP certificates between national competent authorities by eliminating duplication of work and the administrative paper exchange between national competent authorities. It also provides a future platform for facilitating collaboration with international regulatory partners. Authorisation and certificate formats together with relevant procedures are harmonised and published in the Compilation of Community Procedures.
Information in the EudraGMP database is updated on an ongoing basis and in time it is expected that information on around 10,000 manufacturers and importers in the EEA will be included. Each year more than 3,000 new GMP certificates will need to be entered into the database.
The European legislation does not require mandatory routine GMP inspections for active substance manufacturers (see Questions and Answers, section "EU GMP guide part II Basic requirements for active substances used as starting materials"). Therefore, the absence of a GMP certificate for a manufacturer of active substances in EudraGMP does not automatically mean that the manufacturer does not comply with GMP.
