- Traditional Medicine > Traditional, Complementary and Herbal Medicine
- Quality and Safety: Medicines > Regulatory Support
(1998; 49 pages) [French] [Spanish]
On April 1 1996, the "Medicinal Products Act" became effective, laying down the general requirements of the procedure for registration of medicinal products and approval of variations to the terms of registered medicinal products . For the application, a special form has to be used and additional documents concerning chemical, pharmaceutical, biological, pharmacological-toxicological and clinical information has to be submitted, with a summary of product characteristics and information concerning price and design of the package . Special rules governing application for herbal medicines are in preparation.