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Wed 16 May 2012 12:43:22 BST


Welcome to EudraGMP
Directives 2004/27/EC on human medicinal products and 2004/28/EC on veterinary medicinal products introduce the legal framework for the Community database. The concept of a European Inspections database is included in the above specified legislation to provide EEA National Competent Authorities and the European Medicines Agency (EMA) with an overview of the status of pharmaceutical manufacturers. The legislation provides for an electronic tool containing complete information on all pharmaceutical manufacturers. This includes information on Manufacturing and Importation Authorisations (MIA) and Good Manufacturing Practice (GMP) Certificates for authorised sites in the EEA and information on GMP certificates for manufacturers in third countries.

GMP Compliance

Following a site inspection, a certificate of Good Manufacturing Practice shall be issued to a manufacturer if the outcome of the inspection demonstrates that the manufacturer complies with the principles of GMP, as provided by Community legislation. If the outcome of the inspection is that the manufacturer does not comply with the principles of GMP, the information shall be entered into EudraGMP.

The National Competent Authority of Member States who performs the inspection shall enter the GMP Certificates or the Non-Compliance information into EudraGMP.

Manufacturing and Importation Authorisation

The manufacture of medicinal products in the EU is undertaken subject to the holding of a Manufacturing and Importation Authorisation. Such authorisation is also required for imports from third countries into a Member State.
The National Competent Authority of Member States shall enter the Manufacturing and Importation Authorisations that they issue into EudraGMP.

Take the EudraGMP web survey!
Today we have launched a two-week survey to gather feedback on the use of EudraGMP.

We are using the survey to gather information to help us plan the future development of EudraGMP. It includes questions about who uses the website and why they use it. It is also collecting ideas for how the website could be improved. The survey is strictly to gather feedback on the public-facing website interface and not on password-protected applications that may relate to the website.

The survey can be found here. It will take no more than five minutes to complete. It is open until Friday 18 May 2012.

The EudraGMP 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.