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3rd Country Manufacturer
3rd Country ManufacturerOMS Location IdentifierOMS Organisation IdentifierLegal AddressNCA Reference KeyConfidentialEditDelete
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API Registration
The Union format for the API Registration Certificate was established in accordance with Art. 47 of Directive 2001/83/EC as amended, and article 93(2) of Regulation (EU) 2019/6.

The Union format for the API Registration Certificate is published in the Compilation of Union Procedures, which can be found at the following location:
Compilation of Union Procedures on Inspections and Exchange of Information revision 19.1 (europa.eu)

API Registration Certificates are to be entered into EudraGMDP, as referred to in Art. 111(6) of Directive 2001/83/EC as amended, and article 95 (2) of Regulation (EU) 2019/6.

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