Advanced therapy medicinal products

Norma Técnica de Medicamentos de Terapia Avanzada (Technical Standard for advanced therapy medicinal products) (19 pages, in Spanish)

The notified Standard governs the production and quality of the products within its scope, as well as the requirements for obtaining authorizations for their use, within the framework established by the Regulations of the National System for the Monitoring of Pharmaceutical Products for Human Use (MINSAL Supreme Decree No. 3/2010).