Reglamento Técnico Centroamericano 11.03.64:19 Productos Farmacéuticos. Productos Naturales Medicinales para Uso Humano. Requisitos de Registro Sanitario (Central American Technical Regulation (RTCA) No. 11.03.64:19: "Pharmaceutical products. Natural medicines for human use. Sanitary registration requirements") (27 pages, in Spanish)
The purpose of the notified Technical Regulation is to establish the conditions and requirements for the sanitary registration of natural medicines for human use intended for marketing. The Technical Regulation applies to natural medicines for human use that are manufactured or imported by natural or legal persons for marketing in the Central American region. It does not apply to products containing as the constituent responsible for pharmacological activity active substances that are chemically synthesized or isolated from natural material, or to ophthalmic or parenteral pharmaceutical products.