The EudraGMDP Application
EudraGMDP is an
application portal that allows Inspectors of the European Economic Area
(EEA) National Competent Authorities (NCA) to create and enter Good
Manufacturing Practice (GMDP) Certificates (and Planned Inspections),
GMDP Non-Compliance Reports, and Manufacturing/Importation Authorisations
(MIA’s) into a Community database.
In addition to the above functionality, the following modules are available for the data transfer from national systems:
- Wholesale Distribution Authorisations (WDA)
- Good Distribution Certificates (GDP)
- Statements of non-compliance with GDP
- Registration of manufacturers, importers and distributors of active substances for human use located in the EFTA
This database provides inventory of the status of pharmaceutical manufacturers of
both active substances, finished medicinal products and their
presentations that have been subject to inspection by NCA inspectors
either within the EU or in a third country.
Users of all NCAs
connected to EUDRANET, of the EMA and the European Commission can
consult this database via the EudraGMDP application at
https://eudragmdp.eudra.org.
At the time of its initial
launch, EudraGMDP, and the information in its database is not
accessible to other parties than these mentioned above.
EudraGMDP also provides
access to the wider public, subject to restrictions on confidential
and sensitive information. This allows users of the Internet (i.e.
the general public and pharmaceutical industry) to search for GMDP
Compliance, by certificate number or using site details (DUNS Number,
site name, city, country, etc.).
Public users can access EudraGMDP application at eudragmdp.ema.europa.eu.
The EudraGMDP database was developed by the EMA in partnership with the EU National Competent Authorities. It is hosted and supported by the EMA.
Related Topics:
Accessing EudraGMP