Food Supplement Registration in SFDA

Food Supplement Registration in SFDA - Overview

The Saudi Food and Drug Authority (SFDA) is the governing body that has the responsibility of establishing regulations and standards to ensure compliance for food and health supplements. It inspects and licences manufacturers, warehouses, consulting firms, and Marketing Authorization Holder(s) (MAH) and establishes regulations for brand owners, licence holders, and, in some cases, ingredient suppliers.

Vitamins and dietary supplements, along with functional foods, became the key segments for controlling lifestyle diseases in the Kingdom of Saudi Arabia (KSA). Considering the stringent regulations of the SFDA, the KSA is a reference country for the Gulf Cooperation Council (GCC) and the countries in the Middle East and North Africa (MENA) region. The SFDA food registration process requires both food products and health supplements to be registered with it, and the ingredients, label, manufacturer, and source must comply with the SFDA regulations and GCC Standardization Organization (GSO) standards. Manufacturers of food and health supplements also need to submit their licenses and other qualifications, such as ISO certifications, to the SFDA during the registration process.

The executive department for local market controls electronic services and has been designed to build a database that has the details of all the food establishments, food operators, and food items in the KSA. For health supplements, both the establishment and the products, along with the product labels and information, are to be registered with the Electronic Services at the Food Sector under the Food Registration System (FIRS). The application is then reviewed by the scientific panel of the SFDA for acceptance or rejection – a crucial step for food product approval in Saudi Arabia.

Freyr’s expertise lies in assisting manufacturers with end-to-end Regulatory support for SFDA food registration, including Good Manufacturing Practice(s) (GMP) and Halal certifications, SFDA food licences, and SFDA food compliance.

Food Supplement Registration in SFDA - Freyr Expertise

  • Food product compliance Saudi Arabia.
  • Food and Health Supplement Product Classification.
  • SFDA Food Licence.
  • Formula Review/Ingredients Assessment.
  • Food Packaging Labels Requirements.
  • Label and Claims Review.
  • Dossier Gap Analysis and Review.
  • Compilation and Submission of Dossier for SFDA Food and Health Supplement Registration.
  • SFDA Online Food and Health Supplement Registration Submission.
  • Legal Representation for the SFDA.
  • Health supplements Regulatory Marketing Strategy and Regulatory Intelligence (RI).
  • Product-specific Regulatory Guidelines/Standards.

Food Supplement Registration in SFDA - Freyr Advantages

  • End-to-end Regulatory consultation with regards to SFDA food registration.
  • Expertise in online food registration and SFDA submission.
  • Legal Representation capabilities and rapport with the SFDA.
  • A qualified team of experts with hands-on experience across all categories of Foods like health supplements, dietary supplements, Nutraceuticals, Health Functional Foods (HFFs), health functional beverages, Foods for Special Dietary use (FSDU), etc.
  • Support in region-specific Regulatory activities.
  • An extensive partner network across the Globe.
  • A strong relationship with various Health Authorities (HAs).
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