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EUDRA GMDP DATABASE

GMDP Database showing Certificates, Licenses and Non-Compliance.
EudraGMP is the database of the European Community of manufacturing authorisations and of certificates of good manufacturing practice. The EudraGMP system was launched in April 2007, for use by European Medicines Regulators. General public access  via Internet is available since 2009.

Information can be found about:
MIA – Manufacturing and import authorizations
GMP – Good Manufacturing Practice (GMP) certificates.
GMP – Statements of non-compliance with GMP

EudraGMDP – D is the new part regarding DISTRIBUTION – is the new name for the Union
database since 2013.

In addition the following new information are available:
WDA –  Wholesale Distribution Authorizations
GDP – Good Distribution Certificates
GDP – Statements of non-compliance with GDP
API –  Registration of manufacturers, importers and distributors of active substances for human use
located in the EEA

All GMP and GDP certificates are listed in a database by the European Medicine Agency and all GMP and GDP authorities in Europe should enter the GMP and GDP certificates via an interface into this  EMA database.

It’s not complete yet, but it’s growing:

Nearly 700 GDP certificates have been recently added in the EudraGMDP, and also two GDP-non-compliance-reports have been published yet –  on 19.02.2014 + 27.03.2014 , both by the Czech authority.

There the important information wghile using that database may not be forgotten: The absence of a GDP/GMP certificate should not be understood as meaning that the active substance manufacturer in question does not comply with GDP/GMP.

e.g.:

Germany has not entered any data yet – not one single German WDA or GDP certificate can be found.

Anyhow Medizone is full compliant to GDP (https://medizone.com/wp-content/uploads/2013/09/Medizone_GDP_Certificate_17062013_gc.pdf )

and of course holding a valid WDA (https://medizone.com/wp-content/uploads/2013/01/Medizone_Gro%C3%9Fhandelslizenz.pdf)

The database can be accessed via http://eudragmdp.ema.europa.eu

Also a list of the National Competent Authorities (NCA) of the EEA can be found: http://eudragmdp.ema.europa.eu/inspections/viewCompetentAuthorityAddresses.do