Public access to EMEA's community database EudraGMP

On 30 July 2009, EMEA made its community database EudraGMP available to the public. With time, the database will contain all

• manufacturing and import authorisations (MIAs) for medicinal products issued to pharmaceutical companies within the EEA,
• GMP certificates for all GMP inspections conducted within the EEA,
• GMP certificates for all GMP inspections conducted in third countries, including API inspections conducted by an authority in the EEA.

The Danish Medicines Agency is presently submitting all MIAs of Danish pharmaceutical manufacturers to EudraGMP, and we expect that all MIAs will be transferred by the end of January 2010. The Danish Medicines Agency has already given public access to the Danish part of the database where the MIAs transferred via the technical set-up are visible.

The technical set-up, which is to enable the transmission of information about GMP certificates to EudraGMP, is expected to be in place in 2010, after which the GMP certificates will be added to the database as inspections of Danish manufacturers are completed successfully. GMP certificates resulting from a Danish inspection of third country manufacturers will also be submitted to EudraGMP.

EudraGMP has been developed over the past couple of years, and new features will be added to future releases regularly. In the newest release, information about manufacturers' non-compliance with GMP is shared, and future releases will include planning of inspections in third countries and alerts for quality defects.

EMEA expects that the availability of EudraGMP will greatly improve the sharing of information and coordination of MIAs, GMP certificates and non-compliance information between national competent authorities within the EEA. You can read more about EMEA's harmonised templates for MIA and GMP via the link in the factbox to the right.

With time, it is expected that EudraGMP will provide information on around 10,000 manufacturers and importers in the EEA, and that each year more than 3,000 new GMP certificates will need to be entered into the database.

EEA competent authorities currently have full read/write access to EudraGMP. Discussions are ongoing about providing MRA partners access to EudraGMP and giving authorities outside the EEA access for regulatory purposes.

Please see links in the factbox to the right, for more information about EudraGMP and to gain access to the database.

Please note that the Danish Medicines Agency will still be issuing paper MIAs and GMP certificates, which will be submitted by ordinary mail. In addition, the EudraGMP database will not replace the use of free sales certificates.

For further information, please contact Maria Skiffard, tel. +45 4488 9780, mask@dkma.dk

Danish Medicines Agency, 19 November 2009