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Certificates of Free Sale and Non-COFS Document Authentication
ICMAD is one of the associations identified by the FDA as having the expertise to issue Certificates of Free Sale (COFS). Since 1992, ICMAD has issued COFS for cosmetic and personal care products that are made in the United States. ICMAD can provide COFS for ICMAD member manufacturers and distributors, which is defined in accordance with U.S. Food, Drug, and Cosmetic Laws.
ICMAD currently has processes for 140 countries that require COFS. Certificates for Mexico are good for one year, while all other countries are good for two years.
Any product with an active ingredient making it an OTC drug must obtain a Certificate of Free Sale directly from the FDA if the product is ALSO defined as a drug in the country of import. These products may include, but are not limited to: acne, anti-dandruff, benzol peroxide, anti-fungal, teeth whitener, antiseptic, skin whitener, insect repellant.
For further information on this program, contact Beth Ann Watson, Import/Export Coordinator at firstname.lastname@example.org or 800-334-2623, ext. 104.
Requesting a Certificate of Free Sale*
When requesting a COFS please fill out the application form, include the product list on your letterhead and include the appropriate fee. Please do not add anything to the product list page including stamp/notary or signatures. Please note, if the request is made by the products' distributor, the manufacturer(s) must also be a member of ICMAD.
*Countries with special requests for authentication.
Brazil: Brazil requires the product list to be in the body of the Certificate of Free Sale. Please email the product list as a Word document to Beth Ann Watson at email@example.com.
Iran: Iran requires the face value of the products being shipped. The product list needs to have the amount per product and the total. It also wants a signed, notarized letter with the total amount typed on the member company’s letterhead. Please see the links for an example. Please include both documents with the COFS application letter. Note: Iran is the subject of U.S. government sanctions. Please see Iran.PDF for more information. **(At this time we are no longer authenticating Iran certificates.)**
Qatar: Due to a change in government reguirements, ICMAD will no longer be able to process authenticated document requests. If you require authenticated documents for Qatar, you will need to legalize those in the state the documents have been created. ICMAD still issues Certificates of Free Sale to Qatar. Please complete the application and forward a product list without your company address, or email the product list as a Word document to Beth Ann Watson at firstname.lastname@example.org.
Russia: Russian Certificates of Free Sale may require optional translation into Cyrillic (the Russian alphabet). Please indicate on the application if you would like the document translated.