South African companies involved in global trade are often required by importing countries to provide a number of certifications to confirm a product’s quality, safety and compliance with legal standards. Two such documents are the Certificate of Free Sale and the Apostille Certificate.
The Certificate of Free Sale and the Apostille Certificate are key certifications for manufacturers of products such as medical devices, food, cosmetics and biological products to do business in the open market. Both provide assurance that products exported from South Africa are legally sold or distributed in the open market without restriction and have been approved by the regulatory authorities in South Africa. These certifications are often mandatory, and compliance with these requirements instils confidence in foreign regulators and buyers regarding the safety and quality of the goods.
This blog post will provide a comprehensive overview of the Certificate of Free Sale and the Apostille Certificate in South Africa, along with practical guidance on how to streamline the process of obtaining them for more efficient exports.
What is a Certificate of Free Sale in South Africa?
A Certificate of Free Sale, also known as a Certificate of Export, Certificate of Manufacture’ or a ‘Health Certificate’ or ‘Safety Certificate’, is an export document issued by a government authority, like the SAHPRA – South African Health Products Regulatory Authority, or a recognised organisation, such as a chamber of commerce. It certifies that a specific product is legally sold in South Africa. It is often required by customs authorities in importing countries to ensure that the product is legal and meets specific quality standards.
Who needs a Certificate of Free Sale in South Africa?
- Medical device manufacturers in South Africa: Organisations in South Africa engaged in the production and export of medical devices, including surgical instruments, diagnostic tools, and medical supplies, often require a Certificate of Free Sale in South Africa. This is a document that proves the quality and integrity of their products when presenting them to overseas regulatory authorities.
- Pharmaceutical Companies in South Africa: Pharmaceutical producers exporting medicines, vaccines, or other pharmaceutical goods may require a Certificate of Free Sale to satisfy import regulations, particularly when attempting to obtain authorisation to promote and sell their goods abroad. Manufacturers in South Africa of cosmetics and personal care goods may require a Certificate of Free Sale in South Africa to verify that their cosmetics, skincare, and toiletries comply with the safety and quality standards of the intended market.
- Exporters seeking to obtain regulatory approval: A Certificate of Free Sale in South Africa is frequently a mandatory component of the application process for businesses seeking regulatory approvals or marketing authorisations for their products in foreign countries.
What Products Require a Certificate of Free Sale in South Africa?
Certificates of Free Sale are required when exporting a wide range of consumer products to foreign countries. It is typically required for shipments of cosmetics, foodstuffs, personal care products and agricultural products, but other product classes may also require one depending on the specific items involved. These include:
- Seafood
- Biologics
- Nutraceuticals
- Pet foods and pet products
- Food supplements
- Veterinary medicines
- Medical devices
When Do You Need a Certificate of Free Sale in South Africa?
The Certificate of Free Sale is often a mandatory requirement that confirms that the goods are safe, properly labelled, and manufactured in compliance with established standards, ultimately supporting global trade and economic growth. Certificates of Free Sale are typically required in two scenarios:
- Customs Requirements
Countries with rigorous import regulations may require a Certificate of Free Sale to verify the product’s legality and safety. In some cases, a Certificate of Free Sale can also facilitate the import process under free trade agreements.
- Importer Requests
Some importers may request a Certificate of Free Sale as part of their import procedures, even when not required by customs, especially for products that are subject to specific regulations or quality standards.
Countries Requiring a Certificate of Free Sale
While not all countries require a Certificate of Free Sale, most now request such documentation to accompany each shipment or sales transaction. In some cases, the sale of specific products requires the submission of documentation, including a Certificate of Free Sale and certificates of origin. Many developing countries require a Certificate of Free Sale as a condition of importation in sensitive sectors:
- Europe & Eurasia: Russia, Armenia, Belarus
- Middle East : Saudi Arabia, UAE, Egypt
- Asia: China, South Korea, Indonesia, India
- Americas: Argentina, Chile, Ecuador
Legalisation of a Certificate of Free Sale by Apostille
When a South African issued document is to be used for official purposes in another country, it may be necessary to have the document verified and validated. You might think “But it was issued by the government. It’s already valid.” Unfortunately, this is not the case. The legalisation of a Certificate of Free Sale is often mandatory. Legalisation is a formal process that officially validates commercial and legal documents from South Africa. It serves as a guarantee to the recipient country of the documents’ authenticity. This can be achieved through an Apostille, a certificate of authenticity issued by the Department of International Relations and Cooperation (Dirco) in Pretoria or an embassy or consulate in South Africa.
Apostille certificates are currently accepted by over 127 member countries of the Hague Convention (as of December 2024).The Hague Convention of 1961 introduced apostille certificates as a form of legalisation for different types of documents, such as a certificate of free sale.
Should the Certificate of Free Sale be intended for utilisation in a country that is not a signatory to the Hague Convention, further legalisation through the Embassy of the intended country is required.
Frequently Asked Questions about Certificate of Free Sale and Apostille Certificate in South Africa
Q1: How do I know when I need a Certificate of Free Sale?
A1: Usually, the importer of goods into a particular country will inform the exporter that he needs a Certificate of Free Sale to import the goods(s). It is up to the exporter to apply for the certificate.
Q2: Is a Certificate of Free Sale required for each shipment to a specific country?
A2: A Certificate of Free Sale is an indispensable document when registering a new product in a particular country. It is provided to the customs authority of that country, serving as a declaration that the product is new and intended for importation, along with supporting documentation confirming its legality for sale in the country of manufacture. It is therefore necessary to obtain a Certificate of Free Sale for each product being exported to a specific country.
Q3: Is it possible to use the same Certificate of Free Sale for a particular product in multiple countries?
A3: Unfortunately, this is not possible. Each country requires its own certificate because it is a document that is kept on file with their customs authority.
Q4: When a Certificate of Free Sale is filed with the customs authority of a particular country, does it expire at some point?
A4: No, it never expires.
Global Apostille, your document legalisation partner
With over 10 years of expertise in document legislation in South Africa, Global Apostille is your ideal partner for navigating the regulatory landscapes of international markets. Our approach is tailored to meet the unique needs of each client, ensuring a smooth and efficient process to obtain Apostille Certificates. Here’s why you should choose us to assist you:
- Expert guidance: Our regulatory experts provide in-depth insight and support throughout the process.
- Streamlined processes: We handle all aspects of the certification process, making it straightforward and hassle-free.
Tel: 012 348 3134;
Mobile: 081 347 6060;
Email: info@apostillelegalisation.co.za.
www.apostillelegalisation.co.za
