11.120.01

Reglamento Técnico Centroamericano (RTCA) 11.03.59:18, 1era Revisión - Productos Farmacéuticos, Medicamentos para Uso Humano. Requisitos de Registro Sanitario (Central American Technical Regulation (RTCA) No. 11.03.59:18, First revision - Pharmaceutical products. Medicines for human use. Sanitary registration requirements) (31 pages, in Spanish)

The notified Central American Technical Regulation (RTCA) establishes the conditions and requirements for the sanitary registration of medicines for human use. It applies to medicines for human use that are manufactured or imported by natural and legal persons for marketing in the territory of the States Parties.