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As the EMEA points out on its website, "the pharmaceutical legislation
specifically refers to a number of information technology systems for
which the EMEA was given the responsibility to implement certain projects.
Directives 2004/27/EC and 2004/28/EC provide for a database on
manufacturing and import authorisations, GMP certificates and non-GMP
compliance information, currently under development as the EudraGMP
database."
With this database the authority wants to harmonise the receipt and
recording of manufacturing authorisations and GMP certificates. The
exchange of inspection-related data will also help both the EMEA and the
member states in planning their inspection schedules. The facilitated
joint access to this information will enable an optimised use of the
existing resources and contribute to a reduction of multiple inspections,
especially in third countries.
With about 20,000 importers and manufacturers within the European Economic
Area (EEA), the Agency expects up to 10,000 entries per year. Besides, the
database has to be updated continually due to inspections in third
countries and the new GMP requirements on active ingredients and certain
excipients.
The competent authorities within the EEA will have unlimited read/write
access to the EudraGMP database, whereas the general public will be able
to view information that is not of confidential nature. Moreover,
discussions with MRA partners are planned for the near future - with the
goal to replace the paper exchange of certificates.
A first version of this database is planned to go online at the end of
this year.
The complete document can be found here:
www.emea.eu.int/Inspections/EudraGMP.html
Compiled by:
Wolfgang Heimes
On behalf of ECA
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