Free Sale Certificate
A Free Sale and Commerce Certificate is a certificate issued for export of any other item which is not restricted or prohibited for export confirming that the product is freely sold in the country but without any indication that the product is evaluated for safety and efficacy and is registered for use in the country. It gives an assurance from a foreign agency that the products listed on the certificate are freely sold and manufactured in the country seeking to export a particular item.
Manufacturer exporters or merchant exporters may be benefitted from the Free Sale and Commerce Certificate.
Free Sale and Commerce Certificate may be issued for exports as under:
- For items not covered under the Drugs and Cosmetics Act, 1940, which have usage in hospital, nursing homes and clinics for medical and surgical purposes and are not prohibited for export.
- Any item that is not restricted or prohibited for expor
In India State licensing authority is responsible for issuing Free Sale Certificate for Drugs and cosmetic products for export purpose.
Following documents are required for issuing a Free Sale Certificate –
- Application in the Form of Descriptive covering letter.
- Copy of the valid manufacturing licences
- List of products for which Free Sale Certificate are required
- Copies of the product permission letters of the requested products for the issue of Free Sale Certificate
- Letter of the concerned authority-demanding certificate
- Copy of the power of attorney/authorization letter
The above documents and fees mentioned are just indicative. The list is subject to change depending upon the regulatory authority requirement from time to time.
A flat registration fee of INR 1000/- will need to be paid through electronic mode in the online system for each application for issuance of the authorisation
A Free Sale Certificate is valid for 2 years from the date of issued. The validity of the exports under the Free Sale and Commerce Certificate cannot be extended beyond 2 years from the date of issuance.