NI Nicaragua
  • 11 - Health care technology

Pharmaceutical products (HS code: 30); Medicines (ICS 11.120.10)

NTON 19001:2022 Requisitos para la Autorización de Ensayos Clínicos de Medicamentos en Seres Humanos (Nicaraguan Mandatory Technical Standard (NTON) No. 19001:2022 Requirements for the authorization of clinical trials of medicines on humans) (83 pages, in Spanish)

The purpose of the notified Regulation is to establish requirements and procedures for the regulation of clinical trials of safe, quality and effective medicines on humans. It is applicable to all clinical trials of medicines on humans in authorized institutions for this purpose.