Definition:
A product would be considered as a health product subject for registration when it falls within the following definition. Finished, labelled product in pharmaceutical dosage form which may contain one or more of the following ingredients:
- Products contain one or more vitamins and/or minerals with concentrations equal or below the upper concentration limit provided, and that none of these vitamins and/or minerals are below the lower concentration limit.
- Sulphur in concentration higher than 2 %.
- Antiseptic products contain Benzalkonium, Benzethonium, Chlorhexidine, Chloroxylenol, Methylbenzethonium, Povidone-iodine and Hydrogen peroxide (H2O2)
- Alcohol hand sanitizers composed of these ingredients; Ethanol 60-80% and Isopropanol 60-70%
- A product would be considered as a medicinal herbal product when it falls within the following definition.
Finished, labelled products in pharmaceutical dosage forms that contain one or more of the following:
Powdered plant materials, extracts, purified extracts, or partially purified active substances isolated from plant materials.
- The number of herbs in the oral dosage form products should not exceed five herbs.
- Homoeopathic preparations are not allowed to be marketed in Saudi Arabia due to the lack of supporting evidence of its safety and efficacy.
Required Services:
- Establishment Licensing System (ELS)
- Warehouse registration
- Drug Establishment National Registry (DENR)
- Saudi Drug Registration (SDR)
- Products Registration
| # | Product Submission Process | Working Days |
| 1 | Health and herbal | 155 Working Days |
The validity of Health & Herbal product registration and warehouse registration is FIVE YEARS.
| # | Product Type | File Submission Fee | SDR Online Application Fee |
| 1 | Health and Herbal Products | SAR 20,000.00 | SAR 4,000.00 + KSA VAT |