11.120.01

NTON 19 011- 19 Medicamentos de Uso Humano. Vacunas. Requisitos de Registro Sanitario (Nicaraguan Mandatory Technical Standard (NTON) No. 19 011-19: Medicines for human use. Vaccines. Sanitary registration requirements) (34 pages, in Spanish)

The notified Technical Standard establishes the requirements governing the registration of vaccines for human use, the renewal of and changes to sanitary registration, and the batch release of such vaccines. The notified Technical Standard applies to natural and legal persons established in Nicaragua and engaged in the manufacture, importation, distribution and marketing of vaccines for human use.