SFDA Health and Herbal Products Registration

Herbal and health products in Saudi Arabia are regulated by the Saudi Food and Drug Authority (SFDA). Companies planning to register these products must ensure compliance with the defined data requirements for quality, safety, and efficacy to avoid delays or rejections. 

Food/Dietary supplements with medical claims or concentrations above the limit are considered as health or herbal products in Saudi Arabia. Therefore, they are harder to register than in other countries with less stringent regulations regarding medical claims.

In this article, we will discuss the mandatory requirements that applicants must know to register their Herbal and Health products with SFDA, including product definitions, dossier requirements, labeling, variations, renewals, and other regulatory considerations. 

What are health products? 

SFDA defines health products as finished labeled products in pharmaceutical dosage form intended to exert pharmacological, immunological, or metabolic actions. SFDA mandates that a certain group of products is registered as Health products before being marketed in the Kingdom of Saudi Arabia.  

This group of products includes: 

• Alcohol hand sanitizers composed of Ethanol 60%-80% and Isopropanol 70%. 
• Throat lozenges consisting of volatile oils, ascorbic acid or its salt, and menthol at a concentration of 5mg or higher. 
• Topical products containing organic acids at concentrations above 10%. 
• Skin care products containing urea at concentrations exceeding the GSO-recommended limit for cosmetic products. 
• Aromatic and medicinal herbal oils containing one or more oils extracted from medicinal plants having non-nutritional claims and for internal use. 
• Products containing medicinal herbs that have undergone any manufacturing process and are not in their natural form. 
• Insect repellents applied directly to human skin.
• Topical patches, creams, ointments and gels containing counterirritant ingredients for temporary relief of muscle and joint pain through external application.

Safety and efficacy of health products 

SFDA emphasizes the safety and efficacy of health products and determines them with the following evidence: 

• Clinical studies include systematic reviews, such as meta-analyses of randomized controlled trials, and non-experimental observational studies, such as epidemiological and cohort studies. 
• Regulatory Documents. e.g., assessment report, community herbal monograph, etc 

What are herbal products?

SFDA defines herbal products as any plant or herb manufactured in a pharmaceutical dosage form and presented with a medical claim and are grouped into 2 categories: 

Traditional herbal products 

The products that have a documented traditional use for at least 30 years and/or are registered in Stringent Regulatory Authorities (SRAs) and are consistent in active substances, indication, strength, pharmaceutical dosage form, dosing frequency, the route of administration, and are the same as that of the innovator product fall under this category. 

Non-traditional herbal products

These products are stand-alone applications and therefore must be supported by scientific evidence. Non-traditional herbal products should be supported by scientific evidence demonstrating safety and efficacy. Acceptable evidence may include clinical studies, such as systematic reviews, meta-analyses of randomized controlled trials, randomized controlled trials, and non-experimental observational studies, including epidemiological and cohort studies, as well as regulatory references such as assessment reports and community herbal monographs.  

Safety and efficacy of herbal products

SFDA specifies that the evidence related to the safety and efficacy of herbal products should be derived from recognized and authorized sources, including:

The evidence must demonstrate consistent use for at least 30 years. A source published 30 years ago will not be considered sufficient. There must also be a connection between the duration of use and the claimed use. 

Registration Requirements

Dossier format and Modules

Dossiers for herbal and health products are submitted in the Common Technical Document (CTD) format via SFDA’s electronic Saudi Drug Registration (eSDR) system, which includes Modules 1, 3, and 5. Module 1 consists of the administrative part. Module 3 comprises all quality-related documents, including the drug substance section from the finished-drug manufacturer, the Drug Master File (DMF) from the API manufacturer, and the drug product section. Module 5 consists of clinical study reports and literature references. A complete dossier submission must include: 

Dossier Files for Health and Herbal Products

The CTD Structure for both health and herbal product submissions 

Section	Requirements
Module 1	Regional Administrative Information
1.0	Cover letter
1.1	Table of content
1.2	Application Form
1.3	Product Information
1.3.1	Summary of Product Characteristics (SPC)
1.3.2	Labeling
1.3.3	Patient information leaflet (PIL)
1.3.3.1	Arabic leaflet
1.3.3.2	English leaflet
1.3.4	Artwork (Mock-ups)
1.3.5	Samples
1.7	Certificates and Documents
1.7.1	GMP Certificate
1.7.2	CPP or Free sales
1.7.3	Certificate of analysis – Drug Substance / Finished Product
1.7.4	Certificate of analysis – Excipients
1.7.5	Alcohol-free declaration
1.7.6	Pork- free declaration
1.7.7	Certificate of suitability for TSE
1.7.8	The diluent and coloring agents in the product formula Patent Information
1.7.9	Patent Information
1.7.10	Letter of access or acknowledgment to DMF
1.7.11	Marketing Authorization Holder
1.7.12	Commercial Agency contract “Agent”
1.8	Pricing
1.8.1	Price list
1.8.2	Other documents related
1.9	Responses to questions
Module 3	Quality
3.1	Table of content
3.2	Body of data
3.2.S	Drug Substance Part
3.2.P	Drug Product Part
3.3	Literature References
Module 5	Clinical Study Reports
5.1	Table of Contents of Module 5
5.2	Tabular Listing of All Clinical Studies
5.3	Clinical Study Reports
5.4	Literature References

Dossier Files for certain Health Products

The following documents constitute the minimum requirements to be submitted in the dossier for a specific group of health products, such as sanitizers and lozenges. However, the requirements may vary on a case-by-case basis, and SFDA may request additional documents whenever deemed necessary. 

Section	Requirements
Module 1	Regional Administrative Information
1.0	Cover letter
1.1	Comprehensive Table of Contents
1.2	Application Form
1.3	Product Information
1.3.2	Labeling
1.3.4	Artwork (Mock-ups)
1.3.5	Samples
1.7.2	CPP or Free sales
1.7.6	Pork- free declaration
1.7.11	Marketing Authorization Holder
1.7.12	Commercial Agency contract “Agent”
1.9	Responses to questions
Module 3	Quality
3.1	Table of contents of Module 3
3.2.S.2.1	Manufacturer(s)
3.2. P.1	Description and Composition of the Drug Product
3.2. P.3.1	Manufacturer(s)
3.2.P.4.1	Specifications
3.2.P.5.1	Specifications
3.2.P.5.2	Analytical Procedures
3.2.P.5.4	Batch Analyses
3.2.P.6	Reference Standards or Materials
3.2.P.7	Container/Closure System

How to present PIL and Labeling information

These factors are required to be considered for labeling requirements and presenting PIL:

• Products with different strengths must have distinct packaging color codes to differentiate between them. 
• All companies should disclose all ingredients that may cause allergies, such as Gluten, and/or be contraindicated with chronic diseases like Diabetes and high blood pressure. 
• For herbal substances, the Latin name should be provided. 
• Arabic translation should be added on the package if the PIL is not provided. 
• The Patient Information Leaflet (PIL) should be clear and easy to read for the general public.

Naming and designing of packaging 

These factors are required to be considered when choosing names and packaging designs for herbal and health products: 

• Assessing the suitability of the proposed approved name, including the approved herbal name, approved herbal substance name, approved ingredient name, etc. 
• If the product includes more than one active ingredient, the trade name should include all active ingredients, not just one; otherwise, the company can suggest a different trade name. 
• If the product contains a single active ingredient, the active ingredient name may be used as a trade name, subject to the addition of either the company full name or abbreviation. 
• The outer package, product label, and PIL shall not include any images, figures, logos, or phrases that may lead to undesired consequences. 
• Primary packaging should mention the product name and strength.  
• A product’s primary and secondary packaging should have an identical or linked visual style. 

Variations 

Variations may be minor or major, so the documents are submitted to the SFDA based on the type of variation. For instance, if there is a change to the ATC code or a minor change to the manufacturing process, it is considered minor, and only the relevant pages of the finished product dossier and DMF need to be replaced. If there is a change in the API, such as a change to the extraction solvent or the ratio of herbal drug to herbal drug preparation, where the efficacy/safety characteristics are not significantly different, a variation in the form of a new application must be submitted to the SFDA.

Renewal

Companies must maintain the validity of their registration certificates and apply for renewal at least 6 months before their expiry, in accordance with the SFDA’s guidelines. 

Veterinary Herbal products

SFDA defines veterinary herbal products as any plant or herb manufactured in a pharmaceutical dosage form and intended to prevent or treat disease in an animal. 

However, if the product consists of dried or crushed herb(s) intended for oral administration or for use in an animal’s feed/diet and has no pharmacological action/physiological function, it is not regarded as a veterinary herbal product. 

Read more: Data requirements for veterinary herbal products registration in Saudi Arabia.

Important Notes

• The use of ethylene oxide is prohibited for the decontamination of herbal substances. 
• The shelf life must be based on scientific data. SFDA may check the data through the internal regulatory mechanisms. 
• The maximum permitted shelf life is 5 years and applies to the product in its final container. 
• Results of stability studies for at least 12 months should be available at the time of submission. 
• The product must not contain more than five herbs in accordance with the SFDA guideline. 
• The product must not contain more than two Active Pharmaceutical Ingredient (APIs) manufacturers for each one. 
• If the product contains vitamins or minerals, then it must be within the limits. 
• The product should not contain any medicinal constituent. E.g. Vasodilators. 
• The product should not contain any prohibited constituent. E.g., hormones. 

Registration Support 

At Pharmaknowl, you can connect with our team of experts experienced in classifying your products, determining the requirements, risks, timelines, and budget needed. We provide submission services on behalf of Marketing Authorization Holders (MAHs) in an easy, clear, and smooth way.