This EudraGMDP system help provides instructions for EudraGMDP functionality and details the main functions of the application. It also includes instructions for use of the ECD Manager features that are required that enable the use of EudraGMDP
The help can guide you through the creation, saving, editing and printing of GMP Certificates (and draft Planned Inspections), Non-Compliance Reports and Manufacturing & Importation Authorisations, Wholesale Distribution Authorisation, GDP Certificates and API Registrations.
The help does not describe any of the underlying business processes. These are defined in the Compilation of Community Procedures found on the EMA's Inspections>GMDP/GDP compliance>Community procedures web page: Compilation of Community Procedures on Inspections and Exchange of Information.
The EudraGMDP database was developed by the EMA in partnership with the EU National Competent Authorities and is hosted and supported by the EMA.
EudraGMDP has been in production since 2007.
Related Topics:
EudraGMDP Application - What's it for?