Prior to importing or marketing health supplements in Egypt, they are required to be registered. Depending on the composition, concentration, purpose, and claims made about the product, it is under the control of either the National Food Safety Authority (NFSA) or the Egyptian Drug Authority (EDA).
This guide covers the process of registration, regulatory aspects, labelling, import, and compliance issues.
Regulatory Authority for Health Supplements in Egypt
Health supplements in Egypt are regulated by the following bodies:
National Food Safety Authority (NFSA)
The NFSA is responsible for the product registration, safety evaluation, labelling, importation and compliance of food supplements.
Egyptian Drug Authority (EDA)
Products which are classified as complementary pharmaceuticals are regulated by the EDA on the basis of their composition, their concentration and their therapeutic application.
What is a Health Supplement According to Egyptian Regulations?
Health supplements are products that are derived from vitamins, minerals, amino acids, botanicals, probiotics, or other substances that are used as supplements to the diet.
Product regulation depends on their composition, concentration, and claims. Depending on the types, the NFSA will regulate them as food supplements, while the EDA will regulate them as complementary pharmaceuticals.
Also Read: Drugs vs Medicines: Understand The Key Differences
Health Supplement Registration Compliance Checklist in Egypt
Prior to applying for registration, please make sure that:
- The concentration limits on the Whitelist are correctly applied to the product and classify it under the NFSA or EDA.
- The concentration of the active ingredients is in accordance with the requirements.
- The manufacturing facility is Good Manufacturing Practice (GMP) compliant.
- All the technical and administrative documents have been included in the registration dossier.
- The Product Labelling meets the Egyptian requirements.
- The product is registered in advance by the competent authority before it’s imported or marketed.
Health Supplement Registration Process in Egypt
The registration depends on the product being regulated by the NFSA or the EDA. Below is the step-by-step registration process.
Step 1: Identify the Regulatory Authority
Group the products according to ingredients, concentration, dosage and claims. Products in the Whitelist limits are under the control of NFSA, and those above the limits are under the control of EDA.
Step 2: Register the Food Establishment
Be sure to register the responsible food establishment in the NFSA Unified Registration Portal prior to submitting a product application.
Step 3: Prepare the Registration Dossier
Prepare necessary documents such as product formulation, Certificate of Analysis (CoA), manufacturing information, specifications, product label and supporting certificates (GMP, Free Sale Certificate if applicable).
Step 4: Submit the Application
Submit the registration dossier for regulatory review. The authority may ask for further information, supporting documents or updates to the labels before giving approval.
Step 5: Approval and Market Entry
Following approval, the product can be imported and marketed in Egypt, subject to applicable import requirements.
Documents Required for Health Supplements Registration in Egypt
Common documents required for registration:
- Product registration application
- Product formulation and quantitative composition
- Certificate of Analysis (CoA) from an accredited laboratory
- Product specifications
- Good Manufacturing Practice (GMP) certificate
- Certificate of Free Sale (for imported products)
- Product Label / Artwork
- Manufacturing site details
- Applicant’s / local importer’s commercial registration certificate
- As required, Power of Attorney/Authorization Letter
- Additional quality or safety documentation requested by the NFSA
Egyptian Labelling Requirements for Health Supplements
Food supplements that are sold in Egypt must be compliant with the NFSA food labelling requirements. Labels should be in Arabic and should not be added after customs clearance.
Labels should include:
- Product name
- Ingredient list
- Net quantity
- Manufacturer’s name and address
- Importer’s name and address
- Country of origin
- Batch/Lot number
- Production and Expiry dates
- Storage conditions (when applicable)
- Directions for use
- Nutrition information (where applicable)
Licensing Requirements for Health Supplements in Egypt
The approval process is required for the manufacturing, importation, and marketing of health supplements in Egypt before they can be sold.
- Food establishment registration: Food establishments such as manufacturers, importers, and warehouses shall register with the NFSA by using the Unified Registration Portal.
- Food import license: Importers are required to get the NFSA food import license to import health supplements. In addition, licensed importers can apply to be placed on the NFSA Whitelist, for which reduced inspection and sampling frequencies are allowed for compliant importers.
- Product registration: All health supplements are required to be registered with the NFSA / EDA, depending on the classification of the product.
GMP Requirements for Health Supplements in Egypt
Health supplements should be made in GMP-accredited manufacturing facilities and in accordance with food safety regulations. The authority might also request evidence, including a GMP certificate, manufacturing site details and supporting quality documentation during the registration process. Pre-market NFSA inspection, sampling and laboratory testing are also possible for imported products.
Health Claims and Advertising Regulations in Egypt
Labels and advertising for food products, including health supplements, are regulated by NFSA. No products may be marketed that claim to cure, treat, or prevent diseases. All nutrition and health claims should be in accordance with Egyptian regulations, and labelling and advertising should not be misleading or false.
Import Regulations for Health Supplements in Egypt
Imported health supplements are subject to prior registration by the NFSA or EDA. All importers are required to have an NFSA food import license, meet the Arabic labelling requirements for products and provide the necessary import paperwork for customs clearance. The NFSA can also inspect, sample and test imported consignments.
Health Supplement Registration Timelines in Egypt
The timeframes for registering differ based on the level of completeness of the dossier, product classification, laboratory testing, and answers to regulatory questions. The authority normally registers Special Dietary Food and food supplements within 60 days of receiving the complete application.
Health Supplement Registration Costs in Egypt
Health supplement registration fees are not published publicly by the NFSA. The total registration fees depend on the product category, testing fees, documentation, government fees, legalisation of the documents, translation and local representation.
Conclusion
Accurate classification of health supplements and a full health supplement registration package, in addition to compliance with relevant NFSA or EDA requirements, are essential for successful health supplement registration in Egypt.
Artixio assists manufacturers in Egypt with end-to-end regulatory strategy, product classification, dossier preparation, product registration, and market entry. Please contact us: info@artixio.com.
FAQs
Can foreign manufacturers register health supplements directly in Egypt?
Foreign manufacturers must register through an NFSA-licensed local importer or authorised representative.
Does the NFSA inspect imported health supplements?
Yes. The NFSA may inspect, sample, and test imported consignments before release.
What happens if a product does not comply with Egyptian regulations?
Non-compliant products may be refused registration or denied market access.
