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  1. Human Drug Imports

Human Drug Export Certificate Application Instructions

Facilities may request a certificate of pharmaceutical product or CGMP declaration using the CDER export certification and tracking system (CDEReCATS). CDEReCATS offers several benefits, including a possible reduction in certificate processing time, a guided step-by-step application process, real-time validation of data and e-mail notifications of status updates for the CPP request. 

In order to access CDEReCATS, a facility must have a FURLS account ID and password from the FDA industry systems/FDA unified registration and listing systems (FURLS). Facilities that do not currently have a FURLS account may create a new account to gain access to FURLS. 

Facilities may be asked to upload attachments depending upon the type of CPP requested. The attachments may include pictures of drug labels (immediate package and outer package), approval letters, formulation pages, product inserts, etc. CDEReCATS will guide users through the process and direct users to the appropriate application information. 

FDA prefers electronic submissions. Applying for an export certificate using the online CDEReCATS portal will likely reduce the certificate processing time, however, if facilities wish to apply for a CPP by paper submission, please use Form FDA 3613f

See the application guide for additional information and step-by-step instructions.  

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