Free Sale Certificate: Ensure Your Product’s International Market Access

Cinterqual
2 days ago
2 min read

Looking to export your products smoothly and legally? A Free Sale Certificate (FSC) might be exactly what your business needs to demonstrate compliance and gain access to international markets.

What is a Free Sale Certificate?

A Free Sale Certificate (FSC) – also known as CVL or CLV – is an official document proving that a product complies with the legal requirements of the country where it is manufactured and can be legally sold there.

It is usually requested by the manufacturer or their authorised representative, provided they are established or fiscally registered in the country of issuance. The certificate is issued by the competent national authorities, depending on the product category.

What is the purpose of the FSC?

The FSC serves mainly to facilitate exports to third countries, providing formal evidence that the product meets all legal and technical requirements of its origin country.

It is important to note that the FSC does not replace the regulatory requirements of the destination country. Exporters must ensure compliance with all applicable laws in the target market.

Does the FSC have an expiration date?

Free Sale Certificates do not have a fixed validity period, as they represent the product’s compliance on the date of issuance. If there are changes in the product or its documentation, a new certificate must be requested.

Mutual recognition agreements

To reduce trade barriers and encourage product circulation, the European Union has established mutual recognition agreements with several countries and territories. A key example is the EEA-EFTA Agreement, which enables countries from the European Free Trade Association to access the EU internal market.

Who issues FSCs in Portugal?

In Portugal, the issuing authority depends on the product category:

Food Supplements – issued by the Directorate-General for Food and Veterinary (DGAV)
Medical Devices and Cosmetics – issued by INFARMED – National Authority of Medicines and Health Products

How to obtain your Free Sale Certificate?

To obtain a FSC, companies must:

Understand the regulatory requirements for their productIdentify the appropriate issuing authorityPrepare and submit the necessary legal and technical documentation

At Cinterqual, we provide specialised regulatory support to companies that wish to export, ensuring product compliance and assisting in the certification process.