Statements of non-compliance with GMP now publicly available in EudraGMDP

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18/12/2013

Statements of non-compliance with GMP now publicly available in EudraGMDP

The European Medicines Agency (EMA) has launched a new version of the EudraGMDP database which includes, among other changes, the publication of statements of non-compliance with good-manufacturing-practice (GMP).

Regulatory authorities conduct inspections of manufacturing sites and issue GMP certificates when they conclude that a site is GMP compliant. When inspectors conclude that a site is not GMP compliant, a statement of non-compliance with GMP is issued and regulatory authorities enter the document in EudraGMDP. These non-compliance documents are now publicly accessible as well as the positive GMP certificates.

Statements of non-compliance contain information on the nature of the non-compliance and the actions taken or proposed by the issuing authority in order to protect public health. These statements aim to establish a coordinated and harmonised response by the network of European Union (EU) medicines regulators.

EudraGMDP is a database operated by the EMA that supports the exchange of information on GMP compliance and non-compliance, as well as on manufacturing and importation authorisations, among European regulatory authorities and regulators outside the EU. 

As of April 2013 the database also includes information on good-distribution-practice (GDP) compliance, as well as registrations of active substance manufacturers, importers and distributors and wholesale distribution authorisations. 

Most information contained in EudraGMDP is publicly available. Information of a commercially or personally confidential nature is not made public. The decision on which information to make public is taken by the medicines regulatory authority in the EU Member State that adds the information to the database.

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