Description
EudraGMDP is the name for the Union database referred to in article 111(6) of Directive 2001/83/EC and article 80(6) of Directive 2001/82/EC.
It contains the following information:
- Manufacturing and import authorisations
- Good Manufacturing Practice (GMP) certificates.
- Statements of non-compliance with GMP
- GMP inspection planning in third countries
- Wholesale Distribution Authorisations
- 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 EEA
Resources
| Name | Format | Description | Link |
|---|---|---|---|
| Access the EudraGMDP database | HTML | Open resource |