Herbal medicine regulation in Saudi Arabia was established in 1996 is the issue of a separate law specifically for herbal medicines. The regulatory categories for herbal medicines include over the counter medicines, dietary supplements, health foods and functional foods. By law, medical, health, nutrient content and structural function claims may be made. An herbal preparation is defined as a product prepared for therapeutic and/or prophylactic use, the active ingredients of which are of plant origin. The definition is limited to preparations to be administered locally, orally, rectally or by inhalation. In accordance with ‘Regulations for Registration of Herbal preparations, Health and Supplementary Food, Cosmetics and Antiseptics that have medicinal claims’ issued by the Ministry of Health of the Kingdom of Saudi Arabia, the formal application for registration which is submitted to the General Directorate of Medicinal and Phamaceutical Licences at the Ministry of Health is based on registration of the products in the country of origin. Therefore documents such as manufacturing licences, free sales certificates and GMP certificates have to be submitted with information on composition, therapeutic category, certificate of analysis, percentage of alcohol and in case of ingredients of animal origin, the kind of animal. Furthermore full specifications and methods of analysis of the finished product, data on stability studies and storage conditions, six samples of the product and of the outer package and label together with abstracts of scientific references testifying to the efficacy and safety of the product have to be submitted. Handling of locally produced or imported products is prohibited before registration by the Ministry of Health. After registration it is not allowed to make any change in the composition, specification, method of manufacturing, indications, container or package unless it has been approved by the authority. A registration may be cancelled by the authorities under certain preconditions. The registration committee reviews registered products after three years from the date of registration, or as deemed necessary, to consider for re-registration.