Regulatory Open Forum

Hi All,

Is it the FDA or USDA that will grant permission to export an animal vaccine API internationally? We are making the API here in the US and sending it to Taiwan for vaccine manufacturing, packaging and marketing. 

Thanks for your help.

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Scott Volz
United Biomedical Inc
Hauppauge NY
United States
-------------------------------------------

Scott,

Regulatory Doctor advised a firm trying to import animal vaccine products last year from an Asian country to the US.  

Without knowing what your "animal vaccine API" is, I have to exercise some assumption here.  

Assuming your animal vaccine API is part of animal products, then it is likely to be governed by the international animal product expert regulations.  

Thus, it falls under the jurisdiction of the USDA.  

Please refer to the USDA form VS Form 16-4 at http://regulatorydoctor.com/?attachment_id=18284

Generally speaking, when trying to figure out expert matters of whose jurisdiction of the product falls under, it is helpful to visit Expert.gov, in particular, export licenses, for example,  http://regulatorydoctor.com/?attachment_id=18280

Original Message:
Sent: 05-01-2015 08:41
From: Scott Volz
Subject: Export Certificate

Hi All,

Is it the FDA or USDA that will grant permission to export an animal vaccine API internationally? We are making the API here in the US and sending it to Taiwan for vaccine manufacturing, packaging and marketing. 

Thanks for your help.

-------------------------------------------
Scott Volz
United Biomedical Inc
Hauppauge NY
United States
-------------------------------------------

Scott,

It was meant to mean:

export.gov 

AND

the international animal (product) export regulations

D

Original Message:
Sent: 05-01-2015 14:39
From: David Lim
Subject: Export Certificate

Scott,

Regulatory Doctor advised a firm trying to import animal vaccine products last year from an Asian country to the US.  

Without knowing what your "animal vaccine API" is, I have to exercise some assumption here.  

Assuming your animal vaccine API is part of animal products, then it is likely to be governed by the international animal product expert regulations.  

Thus, it falls under the jurisdiction of the USDA.  

Please refer to the USDA form VS Form 16-4 at http://regulatorydoctor.com/?attachment_id=18284

Generally speaking, when trying to figure out expert matters of whose jurisdiction of the product falls under, it is helpful to visit Expert.gov, in particular, export licenses, for example,  http://regulatorydoctor.com/?attachment_id=18280

Original Message:
Sent: 05-01-2015 08:41
From: Scott Volz
Subject: Export Certificate

Hi All,

Is it the FDA or USDA that will grant permission to export an animal vaccine API internationally? We are making the API here in the US and sending it to Taiwan for vaccine manufacturing, packaging and marketing. 

Thanks for your help.

-------------------------------------------
Scott Volz
United Biomedical Inc
Hauppauge NY
United States
-------------------------------------------

Thank you very much. This is a very helpful direction to go in..

-------------------------------------------
Scott Volz
United Biomedical Inc
Hauppauge NY
United States
-------------------------------------------


Original Message:
Sent: 05-01-2015 08:41
From: Scott Volz
Subject: Export Certificate

Hi All,

Is it the FDA or USDA that will grant permission to export an animal vaccine API internationally? We are making the API here in the US and sending it to Taiwan for vaccine manufacturing, packaging and marketing. 

Thanks for your help.

-------------------------------------------
Scott Volz
United Biomedical Inc
Hauppauge NY
United States
-------------------------------------------

Hi, Scott,
To my understanding, you need to check both FDA and USDA regulation for the importation of your API product to US. FDA regulates the end usage of you API, while USDA regulates the material that contains animal ingredient be properly treated before importation. You might need to apply for a USDA importation permit, while your end user should have proper registration with FDA if the finished product is commercialized in the US market.

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Sara Xiao
Princeton NJ
United States
-------------------------------------------


Original Message:
Sent: 05-01-2015 08:41
From: Scott Volz
Subject: Export Certificate

Hi All,

Is it the FDA or USDA that will grant permission to export an animal vaccine API internationally? We are making the API here in the US and sending it to Taiwan for vaccine manufacturing, packaging and marketing. 

Thanks for your help.

-------------------------------------------
Scott Volz
United Biomedical Inc
Hauppauge NY
United States
-------------------------------------------