Welcome to EudraGMDP
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
Almost all information uploaded into the database is available to the general public. National Competent Authorities are able to exclude some information from public view. This includes information of a commercially sensitive or personal nature, inspection planning and information that may need to be restricted in the interests of security.
Users are advised that since inspections of manufacturers of active substances are based on risk, some active substance manufacturers may not be in possession of a GMP certificate issued by an EEA authority. The absence of a GMP certificate should not be understood as meaning that the active substance manufacturer in question does not comply with GMP.
EMA is not responsible for the contents of the database. Any questions on its content should be addressed to the relevant National Competent Authority.