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3rd Country Manufacturer
3rd Country ManufacturerOMS Location IdentifierOMS Organisation IdentifierLegal AddressNCA Reference KeyConfidentialEditDelete
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3rd Country DistributorOMS Location IdentifierOMS Organisation IdentifierLegal AddressNCA Reference KeyConfidentialEditDelete
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API Registration
The Community format for the API Registration Certificate was established in accordance with Art. 47 of Directive 2004/27/EC and Art. 51 of Directive 2004/28/EC, amending Directives 2001/83/EC and 2001/82/EC respectively.

The Community format for the API Registration Certificate is published in the Compilation of Community Procedures, which can be found at the following location:
Compilation of Community Procedures on Inspections and Exchange of Information

API Registration Certificates are to be entered into EudraGMDP, as referred to in Art. 111(6) of Directive 2001/83/EC and Art. 80(6) of Directive 2001/82/EC.

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