Free Sales Certificate
A Free Sale Certificate is a certificate issued by a national regulatory authority of an exporting country based on national legislation 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.
A Free Sale Certificate is also known as a “Certificate for Export” or “Certificate to Foreign Governments”. 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 drug.
In India State licensing authority is responsible for issuing Free Sale Certificate 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
- Fees of Rs. 250/-+ service Tax per Free Sale Certificate containing maximum of 10 products in one certificate and fees of Rs. 50+ service Tax for each additional copy in the form Demand draft/ Pay Order drawn in Favor of Drugs Controller and its Xerox copy
- 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 Free Sale Certificate is valid for 2 years from the date of issued.
- Jani B R. et. al., Free Sale Certificate (Export Certificate). Int. J. Res. Dev. Pharm. L. Sci. April – May 2015;4(3):1470-1488.
- Guidance document on Common Submission Format for Import and Registration of bulk drugs and finished formulations in India. Central Drugs Standard Control Organization, Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India. Available at-https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/import-registration/Import_guidance_doc.pdf, Accessed on 19th March 2016.