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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.

Read-only access to EudraGMDP

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.

  
 
     
 
 
 
The EudraGMDP database is maintained and operated by the EMA. Access to the general public is granted in order to enhance availability of information related to the EMA mandate. The content of the database is provided by the National Competent Authorities (NCA) of the EEA. For this reason, the EMA accepts no responsibility or liability whatsoever (including but not limited to any direct or consequential loss or damage it might occur to you and/or any other third party) arising out of or in connection with the information on this database. Any questions about the content should be addressed to the relevant NCA. Please click here to get list of NCA's.
Due to the restrictions caused by COVID-19, the period of validity of MIA’s, WDA’s, GMP and GDP certificates is automatically extended until the end of 2021. On-site inspections will resume as soon as there is a consensus that the period of the public health crisis has passed. The clarifying remark section of individual MIA’s, WDA’s, GMP and GDP certificates will indicate any exceptions. Competent authorities reserve the right to inspect a manufacturing site should the need arise.
For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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