Bilgiye hızlı erişim:
The FSC is requested to demonstrate that the product intended for export is authorized in its country of origin and is marketed in accordance with local regulations. In international trade, such documents may be considered prerequisites during customs procedures in the importing country.
The certificate is issued by the Turkish Medicines and Medical Devices Agency (TİTCK), affiliated with the Ministry of Health of the Republic of Turkey.
→ The product must be registered in the Product Tracking System (ÜTS) prior to application.
→ Applications are submitted via the e-Government platform or through TİTCK's designated digital systems.
The Free Sale Certificate includes the following essential elements:
Commercial name of the product
Brand name
Company title and address
Manufacturer and exporter details
Official declaration confirming the product is legally sold in Turkey
Approval, stamp, signature, and QR code with verification link issued by TİTCK
This information enables the competent authorities in the importing country to verify the legal status of the product in its country of origin.
The FSC is particularly essential at the following stages of export operations:
Customs entry procedures in foreign countries
Licensing or registration applications in the importing country
Under distribution, contract manufacturing, or agency agreements
For private label products to ensure regulatory compliance and assurance
Some countries have made the submission of an FSC a legal requirement for import procedures. Therefore, it should be taken into account during export planning.
► The certificate is valid for 3 years.
It must be renewed in the following cases or at the end of its validity:
Changes in the product's formulation, name, or packaging
Updates in the brand or manufacturer information
Change of the exporting company
Maintaining an up-to-date and valid certificate is crucial for uninterrupted export operations.
The Free Sale Certificate is an official document required when offering legally manufactured and marketed products in Turkey to international markets. It is used by exporting companies to demonstrate compliance with regulatory authorities and to ensure transparency throughout commercial processes.
Having an FSC is a critical step in proving regulatory compliance and is often a prerequisite in many international markets.
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