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Wed 28 Sep 2016 04:24:08 BST

Welcome to EudraGMDP

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.

Compliance with Good Manufacturing Practice:

A certificate of Good Manufacturing Practice (GMP) is issued to a manufacturer by the national competent authority that carried out an inspection if the outcome of the inspection confirms that the manufacturer complies with the principles of Good Manufacturing Practice, as provided by European Union legislation. If the outcome of the inspection is that the manufacturer does not comply a statement of non-compliance may be entered into EudraGMDP. Certificates and statements of non-compliance may be issued to manufacturers of medicinal products and manufacturers of active substances located inside and outside of the European Union.

Manufacturing and Importation Authorisation:

Manufacture of medicinal products in the EU or importation from a third country is subject to the holding of a Manufacturing and Importation Authorisation. The National Competent Authority of the Member State in which the manufacturer or importer operates issues these authorisations.


Compliance with Good Distribution Practice:

A certificate of Good Distribution Practice (GDP) is issued to a wholesale distributor by the national competent authority that carried out an inspection if the outcome of the inspection confirms that the wholesale distributor complies with Good Distribution Practice, as provided by European Union legislation. If the outcome of the inspection is that the wholesale Distributor does not comply a statement of non-compliance may be entered into EudraGMDP. GDP certificates and statements of non-compliance may be issued to wholesale distributors of medicinal products and distributors of active substances.

Wholesale Distribution Authorisation:

The wholesale distribution of medicinal products is subject to the holding of a Wholesale Distribution Authorisation. The National Competent Authority of the Member State in which the wholesale distributor operates these authorisations.


Registration of Active Substance manufacturers, Importers and Distributors:

Manufacturers, importers and distributors of active substances are required to register their activities with the National Competent Authority of the Member State in which they operate.

 
 
 
     
 
 
 
 
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.
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