- Traditional Medicine > Traditional, Complementary and Herbal Medicine
- Quality and Safety: Medicines > Regulatory Support
(1998; 49 pages) [French] [Spanish]
Herbal medicines have to be registered by the Department of Drug Administration, at the Ministry of Health. Regulatory requirements are: manufacturing licences issued by the concerned Drug Control Authority, price approval and valid price list, letter of warranty of the manufacturer indicating his/her responsibility for safety, efficacy and quality of his products, authorization for import, export and distribution of the product, and the mode of distribution and promotion. Pharmaceutical requirements are the quantitative formula including all excipients, stability data, shelf-life, bioavailability in vitro and in vivo, wherever applicable, a description of the product including container and labelling, and a photograph of each product. For medicinal plants, permission is given by the Department of Forests .