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

In addition the following new information is required in the database for the first time in 2013. As data transfer from national systems can be complex, it will take several months for all the National Competent Authorities to complete the uploading of this data.

• 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

 

General Link to Database