Most of the cosmetic products in Saudi Arabia are imported, making it a lucrative market for the cosmetic industry. However, before a company can begin to market and sell their products in the Kingdom of Saudi Arabia, they must notify and register each product with the local health authority, Saudi Food and Drug Authority (SFDA). SFDA is the regulating body for food, drugs and cosmetics within the Kingdom of Saudi Arabia.
In April 2015, SFDA launched eCosma, an electronic notification system, to ease the process of application for cosmetic product registrations.
The program aims to standardize the registration of cosmetic products in KSA, while simultaneously ensuring safety, security, and effectiveness. The process is straightforward, even if it involves some documentation.
Process for eCOSMA application:
The flowchart below describes the steps to register a cosmetic product in KSA:
eCOSMA cosmetic product registration process
All the documents listed in the flowchart above are mandatory; without them, the application will not proceed. Broadly speaking, there are two types of notifications:
Manufacturer Notification: All foreign manufacturers need to liaise with a resident, who will act as their representative in Saudi Arabia. This representative must have an established license issued by SFDA.
Product Notification: All manufacturers must produce finished label, ingredient list, and a certificate of analysis for each product being registered.
Foreign manufacturer Notification
GMP or Quality Certificate
Good Manufacturing Practice (GMP) certificate ensures that products are consistently produced at the expected quality. The certificate is aimed at minimizing risks involved in any pharmaceutical production that cannot be eliminated by testing the final product.
Marketing Authorization Letter
Marketing authorization letter is also known as distribution authorization letter. With the help of such a letter, the manufacturer issues a notification to a local representative and permits him to import, market, or sell within the KSA.
Contact Person Authorization Letter (in KSA)
The manufacturer authorizes a person and gives his contact details to a Gulf Cooperation Council (GCC) representative to communicate with SFDA when necessary by issuing a Contact Person Authorization Letter.
Relationship letter between the brand owner and manufacturer
If the manufacturer is different from the brand owner, then the brand owner issues a letter stating the relationship between the brand owner and manufacturer.
Free sale certificate
The certificate of free sale is evidence that goods, such as cosmetics, are legally sold or distributed in the open market without restriction and are also approved by the regulatory authorities in the country of origin.
Label of finished product packaging
The finished label should include the following in Arabic:
Manufacturing site name, address, and the country of origin
Instructions of use
In addition, the artwork must include the volume of the package (the container size, unit of measure (UOM), and barcode). Artwork must be printed both at the front and back of the packaging.
This includes the product name, ingredients, percentage of ingredients, CAS number, and purpose of ingredients. This list must be issued by the manufacturer, signed, and stamped.
Certificate of analysis
The Certificate of Analysis is a document issued by Quality Assurance and confirms that a regulated product meets its product specifications. It often contains the actual results obtained from testing, as part of quality control of an individual batch of a product.
Do you need to register your product on eCOSMA?
If you intend to sell your products in Saudi Arabia, then your first step is to get your product registered with SFDA. The entire process could take about a month or a bit more. Although there is a bit of red tape involved; KSA is a lucrative market and the prospect of selling your products in KSA are well worth the effort invested. For assistance on any of the steps above, contact us at email@example.com
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This article talks about the effective regulatory strategies for Medical Devices registration across the globe.