- Traditional Medicine > Traditional, Complementary and Herbal Medicine
- Quality and Safety: Medicines > Regulatory Support
(1998; 49 pages) [French] [Spanish]
In accordance with articles 44 and 50 of the Act for the Practice of the Pharmacy Profession and Trade in Pharmaceuticals and Medical Products, issued by the Royal Decree No. M/18 of 18/03/1398, registration of medicinal products by the Ministry of Health is obligatory. Paragraph 13A of the special provision of regulation for registration which was amended through the Ministerial Resolution No. 1214/20 dated 17/06/1409 subjects to registration, in addition to drugs, products with medicinal claims or containing active ingredients with medicinal effects such as herbal preparations, health and supplementary food, medicated cosmetics, antiseptics or medical devices. A 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 the "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 Pharmaceutical Licences at the Ministry of Health is based on the registration of the product in the country of origin. For this reason, 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 the 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 pre-conditions. The registration committee reviews registered products after three years from the date of registration, or as deemed necessary, to consider the need for re-registration .