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.
EPCG Annual Reporting of EO Fulfillment
Authorization holders shall submit to the RA concerned by 30th of June every year, a report on fulfillment of export obligation through online. Such a report shall contain details such as shipping bill / GST invoice number, date of export / supply, description of product exported / supplied and FOB / FOR value of Export / Supply for both specific as well as average export obligation. Any delay in filing such an annual report shall be regularized on payment of Rs. 5000/- late fees for each financial year per authorization.
Automatic Reduction or enhancement of Export Obligation
In excess of the duty saved amount indicated on the authorization by not more than 10%, the authorization shall be deemed to have been enhanced by that proportion. Customs shall automatically allow clearance of such goods without endorsement by RA concerned. The Authorization holder shall furnish additional fee to cover excess imports affected, in terms of duty saved amount, to RA concerned, at the time of application for EODC. Export obligation shall be automatically stand enhance proportionately.
Excess / reduced duty saved amount may be a result of change in Dollar rates from time of application to time of import or due to enhanced / reduced quantity of imports
Maintenance Annual Average Export Obligation
The export obligation is over and above, the average level of export achieved by you as an authorization holder in the preceding three licensing years for the same and similar products within the overall export obligation period including the extended period (if any). Such average would be the arithmetic mean of export performance in the previous three years for the same and similar products. If your company is a new establishment then your Annual average export obligation would be zero.
The excess exports done towards the average export obligation fulfillment of an EPCG authorization during a year can be used to offset any shortfall in the Average EO done in other year(s) of the EO period or the block period as the case may be, provided Average EO imposed is maintained on an overall basis, within the EO period.