Update Jan 7, 02FDA issues Final Rule:
Exports: Notification and Recordkeeping Requirements
On December 19th, 2001, the FDA issued a final rule concerning the
required notification and recordkeeping requirements for persons exporting
human drugs, biological products, devices, animal drugs, food and cosmetics
that may not be marketed or sold in the United States.
For such products being exported the following records must be made
available to the FDA upon request during an inspection for review and
copying by the FDA:
- Records demonstrating that the product meets the foreign purchaser’s
specifications: The records must contain sufficient information to match the
foreign purchaser’s specifications to a particular export.
- Records demonstrating that the product does not conflict with the laws
of the importing country. This may consist of either a letter from an
appropriate foreign government agency, department or other authorized body
stating that the product has marketing approval from the foreign government
or does not conflict with the country’s laws. Or a notarized certification
by the responsible company official in the US that the product does not
conflict with the laws of the importing country and that includes a
statement acknowledging that he or she is subject to the provisions of 18
U.S. C. 1001.
- Records demonstrating that the product is labeled on the outside of
the shipping package that it is intended for export.
- Records demonstrating that the product is not sold or offered for sale
in the US.
There is a whole additional section of special requirements for
biological products.
This regulations will become effective on March 19th, 2002.
For more information or a copy of the regulation please go to the FDA’s
website at
www.fda.gov/OHRMS/DOCKETS/98fr/112701a.htm
or contact mdi’s
offices at www.mdiconsultants.com
Any questions on this new regulation please email mdi directly at
info@mdiconsultants.com
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