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Sat 27 Jul 2024 10:04:12 BST
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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. |
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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) |
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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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