EudraGMDP database

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Provided by European Medicines Agency

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Dataset information

Catalog

European Medicines Agency

Country of origin

EU institutions

Updated

2019.01.09 00:00

Created

2016.11.16

Available languages

English

Keywords

manufacturer, importer, Good Manufacturing Disribution, Good Manufacturing Practice, medical products, substance, authorisation, distributor

Datasource

Official portal for European data link

Quality scoring

325

Dataset description

EudraGMDP is the name for the Union database referred to in article 111(6) of Directive 2001/83/EC and article 80(6) of Directive 2001/82/EC. It contains the following information: - Manufacturing and import authorisations - Good Manufacturing Practice (GMP) certificates. - Statements of non-compliance with GMP - GMP inspection planning in third countries - Wholesale Distribution Authorisations - Good Distribution Certificates (GDP) - Statements of non-compliance with GDP - Registration of manufacturers, importers and distributors of active substances for human use located in the EEA

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