A free sale certificate, also called "Certificate for Export" or "Certificate to Foreign Government" is a proof that all goods like food items, biologics or cosmetics are sold legally or are getting distributed in the open market without any restriction by the regulatory authorities in their country of origin.
This certificate is granted by the national regulatory authority of the exporting country based on the national legislation which confirms that the specific product is getting sold freely without any sign that the product is under evaluation for its efficiency and safety and is legally registered in the country for its use.
Such a certificate acts as a legal supporting document for products being imported and marketed in a country thus verifying that such products have been tested for quality and safety in their country of origin. This is an important document for obtaining a cosmetic registration certificate in India.
In India, the state licensing authority is solely responsible for providing the Free Sale Certificate for the purpose of export. A free sale certificate is usually issued for a period of 2 years from the issuing date.
Documents needed for issuance of Free Sale Certificate:
- Application including a complete descriptive letter.
- Copy of valid manufacturing licenses.
- The product list for which the free sales certificate is needed.
- The product permission letter copy for issuing the free sales certificate.
- A required fee of INR 250 including service tax per free sale certificate that contains a maximum of 10 products in a particular certificate along with fees of Rs.50 + service tax for each additional copy in the form of demand draft/pay order form in favour of the Drugs Controller and its copy.
- Letter of the respective authority that demands a certificate.
- Copy of the letter of authorization.
The listed documents are just an indicated list and are completely subject to change based on the regulatory authority needed from time to time.
Classification for some specific products
It is also important to note that each free sale certificate is issued on a product to product basis. Which means that each individual cosmetic product will be seen under a different lens depending upon its composition and categorization.
Moreover, for some products the certificate has to clearly state their use as a cosmetic product. Thus facilitating the cosmetic registration process.