Applying for Free Sale Certificate in India: FSC for Export
Manufacturers planning to export pharmaceuticals and other healthcare products are required to procure the Free Sale Certificate. Exporters require the FSC attesting the drug is freely marketed and sold in India without any restrictions.
Use our FSC service for a smooth application. Our support does not end with filling the FSC application. The Pharmadocx Consultants team will provide support till you successfully secure the certificate.
What is a Free Sale Certificate?
Manufacturers planning to export certain products require a Free Sale Certificate or FSC. Notably, it is an export document mandatorily demanded for certain products. This document is issued on the basis of national legislation stating that the product is freely available in the country. However, the certificate does prove the product is tested for safety and efficacy and is licensed for use in the country. The FSC is also known as the “Export Certificate” or “International Government Certificate.” This document is issued by the national regulatory authority of the exporting country.
The FSC is issues for any commodity that is not restricted or prohibited for export. Moreover, the FSC provides the assurance the goods mentioned in the certificate are freely distributed and produced in the country that intends to export the specific drug.
Expert Tips
- A valid manufacturing license is one of the most important requirements for securing FSC
- A legal undertaking stating no market complaint or adverse event has been reported against the product is required
- The required government fee has to be paid to secure the certificate
- A manufacturer with no history of complaints against their products will easily obtain the FSC
Why is a Free Sale Certificate needed?
The FSC is a mandatory document for exporting certain commodities. The FSC is vital for the following reasons:
Verification of the commodity to be exported
The Free Sale Certificate guarantees the authenticity of the product to be exported. The importing country will strictly regulate all the drugs and healthcare commodities entering the country. Thus, it will permit the import of drugs and healthcare commodities that are freely sold in the exporting country. Hence, the exporting country uses the FSC to assure the importing country that the product has been authorized for manufacturing in the country of origin.
Validation of the manufacturer
The FSC is not issued, if the manufacturer does not have a valid license. Hence, the Free Sale Certificate is a definitive proof that the manufacturer holds a valid license. Thus, the importing country can be assured the manufacturer is licensed and authorised to manufacture the drug. Moreover, the FSC validates the authenticity of the drug manufacturer.
Mandatory document for securing permit to export to certain countries
Certain countries mandatorily demand the FSC for granting permit to import healthcare commodities into the country. Thus, exporters will have to procure this certificate to market their product in these countries.
Pro tips for smooth FSC application
There are certain prerequisites for applying for FSC:
- First and foremost, the user profile has to be linked with an Import Export Code. In case the IEC is suspended/cancelled, then you will not be able to apply for FSC.
- A valid registration cum membership certificate (RCMC) must be issued to the IEC.
- A valid digital signature certificate (DSC) has to be registered in the user’s system
Documents required for securing FSC
The following are some of the vital documents required for applying for FSC:
- Cover letter stating the applicant’s name and address that should be duly signed and stamped by the organization’s head. Additionally, the cover letter should be written on the organization’s letterhead.
- A copy of the valid manufacturing license
- A copy of the valid import export code and registration cum membership certificate
- List of products for which the FSC is being applied for
- The product permission letters for the products for which FSC is being applied for
- Letter of the concerned authority requesting for the certificate
- A notarized stamp paper stating no market complaint and adverse event reported against the product
- Copy of the authorisation letter or power of attorney, if required
The above list provides an overview of the documents required. Feel free to contact us for a detailed list of necessary documents for the application. Additionally, we will help you prepare and collate the documents as per guidelines. Our document preparation service will help you easily prepare all the necessary documents within the stipulated timeline. Furthermore, we will gladly provide a detailed checklist of documents for FSC application for easy references.
Expert Insights
- A manufacturer with a valid manufacturing license can only apply for the Free Sale Certificate.
- An undertaking stating that no action has been launched against the FSC applicant with respect to market complaints or adverse events is required. Additionally, the undertaking should state there are no not of standard quality (NSQ) reports against the product in India. This has to be submitted along with the application.
- All the documents submitted for FSC application have to comply with the FSC checklist of required documents.
- Importing countries consider FSC a definitive proof that the manufacturer holds a valid manufacturing license in India.
How will Pharmadocx Consultants help you secure Free Sale Certificate?
- We will share the list of documents required for FSC application. Additionally, we will help you prepare the documents and collate the documents per guidelines. Moreover, our document preparation team provides document drafting service.
- Our team of experts will help you file the FSC application.
- We will provide real time update of the application progress.
- We will provide full support in case of any setbacks or queries. Our team will be there for you till you successfully secure the Free Sale Certificate.
At Pharmadocx Consultants, we are committed to streamline the FSC application process. We will help you secure the FSC in a hassle-free manner so that you can easily start exporting your products. Our FSC application service will ensure your product reaches foreign markets in a seamless manner.
To start your FSC application process, simply fill out the form below and we will get back to you
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Common Frequently Asked Questions on FSC
Why do I need to secure a Free Sale Certificate?
The Free Sale Certificate is an export document mandatorily demanded by certain countries for exporting products to their country. The FSC provides the assurance the goods mentioned in the certificate are freely distributed and produced in the country that intends to export the specific drug. An increasing number of countries is making it compulsory to present FSC to market healthcare products in their country.
My IEC has been suspended will I be able to apply for FSC?
No, if your IEC has been suspended/cancelled, you will not be able to apply for FSC.
Can I file the FSC application via email?
Yes, there is an option to file the FSC application via email. The application form along with the receipt of the fee payment has to be sent to the official email id. To know more about the application form name and other details and requirements, feel free to get in touch with us.
Do I need to have a valid manufacturing license to obtain FSC?
Yes, a valid manufacturing license is a must to obtain FSC. It is one of the mandatory documents for FSC application.
What is the validity of a Free Sale Certificate?
Free Sale Certificate is valid for a period of 2 years from the date of issue.
Do I need a registration cum membership certificate (RCMC) to apply for FSC?
Yes, a registration cum membership certificate (RCMC) is required to apply for FSC.
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