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When do I need an FDA Certificate of a Pharmaceutical Product?
The 'Certificate of a Pharmaceutical Product' conforms to the format established by the World Health Organization (WHO) and is intended for use by the importing country when considering whether to license the product in question for sale in that country. (CBER, CDER, and CVM)
U.S. Food and Drug Administration (FDA)
http://www.fda.gov
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