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Certificates of Free Sale
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 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. These products may include: acne, anti-dandruff, benzol peroxide, anti-fungal, teeth whitener, antiseptic, skin whitener, insect repellant.
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.
In a continuing effort to improve the quality and efficiency of this service, please note the following changes in the ICMAD Certificate of Free Sale Program:
- The creation of a two-tier pricing model, which better reflects the authentication requirements of the more than 140 countries ICMAD services. Please download the application form to view Apostille Countries and Authority Countries.
- This pricing model is all inclusive; shipping charges and certification costs are now part of the fee. No additional invoicing or shipping charges will apply.
- The use of a new courier service, which promises faster turnaround, approximately 2-4 weeks.
- The implementation of an email group, to notify member participants of any changes in the program.
*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 Sheryl Steines 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.)
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.
Authentication of Export Documents
In conjunction with Certificates of Free Sale ICMAD will authenticate documents for export that require a signature. Some examples: Certificate of Origin, Certificate of Manufacture, MSDS sheets, GMP Statement, BSE Certificate,etc. We can only notarize documents that contain the member’s signature and title. The Secretary of State will not accept photocopies. Do not notarize the document, ICMAD will notarize the documents.
The fee for authentication of other documents is $135 for up to 3 documents and $35 for each additional document.Expedited service (2-4 weeks) for these documents is optional at $175 per document. This service reduces the turnaround time by approximately 50%.