Definition Free Sale Certificate

A Free Sale Certificate also known as a “Certificate for Export” or “Certificate to Foreign Governments” is a document required in certain countries or for certain commodities (such as pharmaceuticals). This certificate is issued by a national regulatory authority of the country from which the product is being exported certifying that the products listed on the certificate are normally and freely sold and consumed in its country of origin and are approved for export. A Free Sale Certificate is valid for two years from its date of issuance.

In other words, this certificate issued by a national regulatory authority of an exporting country serves as an assurance that products listed on the certificate are freely manufactured and sold in the exporting country's open markets.

In India, the state licensing authority is responsible for issuing Free Sale Certificate to exporters seeking to export their pharmaceutical products to a foreign country. The certificate of free sale certifies that the goods, such as food items, cosmetics, biologics, or medical devices are freely and legally sold in the open market, and has all the necessary approvals from the regulatory authorities in the country of origin (India in this case)


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Documents required for Sale Certificate

Important documents required to get a Free Sale Certificate, also known as Certificate for Export or Certificate to Foreign Governments, are mentioned as following:

The applicant requesting for Free Sale Certificate need to fill an Application in the form of a descriptive cover letter.

Copies of all the valid manufacturing licenses that that the applicant has

The applicant clearly needs to mention all the products for which he is seeking Free Sale Certificate

Copies of the product permission letters of the requested products

The applicant needs to pay a Fees of Rs. 250/-+ service Tax per Free Sale Certificate. It is to be noted that the maximum number of products for a single certificate cannot exceed ten. The applicant has to pay fees of Rs. 50+ service Tax for each additional copy.

The fees need to be paid in form of Demand draft/Pay order made in favour of Favour of Drugs Controller.

  1. Letter of the concerned authority-demanding certificate
  2. Copy of authorization letter or copy of power of attorney

It is also to be noted that the fees and criteria mentioned above are just indicative and are liable to change from time to time in keeping up with the Government policies.

Free trade certificate used for medical and surgical devices and purposes

There are literally thousands of pharmaceutical products that are sold internationally. Reports suggest that the total value of the global pharmaceutical market is in excess of US$ 200 billion per year. Of this, around 30 to 40 per cent of the amount involves international trade while the rest is consumed within the country where such pharmaceutical products are manufactured.

It is important to note that the amount of pharmaceutical products that is imported varies from country to country. In developing and least developed countries, the portion of imported pharmaceutical products is much higher. There are countries like Fiji, Malawi and Papua New Guinea where the entire need of drugs and pharmaceutical products are met by imports.

The movement of pharmaceutical products in international commerce necessitates the concerned authorities in the importing countries place various checks and balances to ensure that the pharmaceutical products they have received are safe, effective, all the manufacturing conditions have been met and the pharmaceutical products have not undergone any deterioration during transit and as such are of adequate quality when received. A Free Sale Certificate provides assurance to the importing country about the status and quality of imported products.

According to Foreign Trade Policy of India 2015-20, the concerned regulatory authorities (RAs) may issue, Free Sale and Commerce certificate for export of items that are not covered by the existing Drugs & Cosmetics Act, 1940. The Free Sale certificate may be issued for products which are used for medical and surgical purposes in hospitals, clinics, nursing homes and other authorized medical facilities. The Free Sale Certificate can only be issued for items which are not prohibited for export. Validity of such certificate unless otherwise specified will be for a period of two years from the date on which it has been issued.

An applicant wishing to export such items must fill an application for Free Sale Certificate to the concerned regulatory authority as per format in ANF 2 H of Appendices and Aayat/Niryat Forms with Annexure A therein. RA shall issue Free Sale and Commerce Certificate as per Annexure B of ANF2H.

It is also to be noted that the concerned RA may issue Free Sale Certificate for other items as well which do not fall under the prohibited list for export. Validity of such certificate unless otherwise specified will be for a period of two years from the date on which it has been issued.

An application for grant of Free Sale and Commerce Certificate for these items may be made to RA concerned as per format in ANF 2H of Appendices and Aayat/Niryat Forms along with Annexure A therein. RA shall issue Free Sale and Commerce Certificate as per Annexure B of ANF 2H.

How to get Free Sale Certificate?

Many Ministries of Health and other regulators around the world require a Free Sale Certificate from a foreign manufacturer to verify that their product is approved for sale in their home country. In these markets, your Free Sale Certificate must be presented to authorities as part of your registration process. There are few quality service providers who can help you obtain Free Sale Certificate documents for seeking medical device registration. These firms for a set fee can procure a Free Sale Certificate on your behalf for your medical device. These firms can act as Authorized Representative for manufacturers of medical devices intended to sell their products around the world.

Application for free sale & commerce certificate for items other than medical devices/instruments can be downloaded from the Director General of Foreign Trade website:

https://dgft.gov.in/sites/default/files/39A.pdf


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