Regulatory Open Forum

Would like to receive feedback on whether or not export certificates are required for exporting investigational drug product.  Our understanding is there is no US FDA requirement to have export certification per 21 CFR 312.110, as long as there is an open/active IND on file.  

The only instances when an export certificate would be required are:

• If the study protocol has not been submitted to the IND, or
• If the IND is on clinical hold

 

I would appreciate any feedback/experience on export certification requirements.

 

Thank you,

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Alka Majethia, MS, RAC
Gaithersburg, MD
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Alka,

You can also ship materials for clinical investigation without an export certificate as long as shipping to one of the listed countries as listed 802(b)(1)(A) of the Act. http://www.fda.gov/RegulatoryInformation/Guidances/ucm125799.htm#countries

Rob

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Robert Blanks RAC
VP Chemistry Manufacture and Control
Auburndale MA
United States
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Original Message:
Sent: 01-17-2013 13:53
From: Alka Majethia
Subject: Export Certificate Requirement

Would like to receive feedback on whether or not export certificates are required for exporting investigational drug product.  Our understanding is there is no US FDA requirement to have export certification per 21 CFR 312.110, as long as there is an open/active IND on file.  

The only instances when an export certificate would be required are:

• If the study protocol has not been submitted to the IND, or
• If the IND is on clinical hold

 

I would appreciate any feedback/experience on export certification requirements.

 

Thank you,

-------------------------------------------
Alka Majethia, MS, RAC
Gaithersburg, MD
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