Pharmaceutical products (HS tariff heading 30)

Proyecto de Reglamento para el Registro Sanitario Condicional de Medicamentos y Productos Biológicos (Draft Regulation for the conditional sanitary registration of medicines and biological products) (27 pages, in Spanish)

The notified Regulation establishes the regulatory provisions of Article 8 of Law No. 29459 (Law on pharmaceutical products, medical devices and sanitary products), amended by Law No. 31091, in order to regulate the conditional sanitary registration of medicines and biological products with phase III clinical studies.