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The export
market, for California produced foods, drugs, medical devices, and cosmetics, has
increased significantly. Many countries require the submission of export documents issued
by the California Department of Health Services before importation of California
manufactured products is permitted. These documents certify that the manufacturer
and its products are subject to the health standards required by the Department, and that
the Department does not object to the sale of the products in California or the shipment
of the products to other countries. The Department understands that exporters need
these documents quickly to avoid shipping delays and unnecessary storage costs.
The California Health and Safety Code provides mechanisms to assure that adequate
resources are available to provide California exporters with timely export documents.
Effective July 1, 1993, this new law establishes a one-time fee of $101.71
plus an hourly charge of $80 (a minimum charge of $25) to review and process export and
distributor certificates. A flat fee of $15 is charged for an official
copy of a
license, permit, registration, or certificate of manufacture. This law also requires all California
cosmetic manufacturers who apply for export documents to be annually registered and
inspected by the Department. This annual registration fee is set at
$423.24. Please
click
here to download a copy of this application. PLEASE NOTE
NEW ADDRESS: California Department of Public Health, Food and Drug Branch
MS-7602, 1500 Capitol Avenue, Suite 72-436 , Sacramento, CA 95814.
The Department considers two primary factors in deciding whether an export document
should be issued. First, the system of manufacture and quality control used to
produce the products must be adequate; this is determined during our inspections of
manufacturers, distributors, and wholesalers. Second, the products must be properly
labeled; this is determined by a review of product labeling at the time of export
document request. This review must be done at the time of the request because
product labeling is typically not reviewed during the inspection process, and because
existing products are being relabeled and new products introduced into the market place on
a continual basis.
Our goal is to issue export documents within 15 working days of request receipt.
All export document requests must be made using the linked application form and
submitted to our office with the appropriate fee. If you have any questions, please
contact the Export Document Processor at (916)
650-6500 or e-mail to the link above.
As of July 1, 2001, the Department of Health Services, Food and
Drug Branch (FDB), Export Certificate Program upgraded the Export
Document Application procedure to better serve industry and facilitate
trade in California.
For the new program to run smoothly, beginning July 1, 2003, the
Department will no longer accept the old application form, as it does
not interface properly with the new program, which has been tested and
validated. Enclosed is the current application, which can also be
accessed on-line in the future under our website at:
http://www.cdph.ca.gov/pubsforms/forms/Pages/FoodandDrug.aspx.
All applicants must submit labels of the products they are
exporting along with their applications and check or checks (if
requesting notary). For applications submitted without labels, the
Department will make one follow-up contact to request labels be
submitted. If labels are not submitted within two weeks, the
application will be returned. If you have more then 10 products listed
on your application please email your list of products to FDBINFO@dhs.ca.gov
in the MS Excel format for faster processing time.
Due to time constraints, phone calls can not be made to verify
inconsistent information provided on the application. If we find
discrepancies on your application, it will be returned to you for
correction, and your certificate will not be issued until the
corrections have been received.
The fee for each certificate is $25 and any certificates requiring
special verbiage not consistent with the standard wording, or
certificates requested in a foreign language will cost $80 each.
If you have any questions, please contact Melissa Mansfield at (916)
650-6519.
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