G/TBT/N/NIC/172  
8 June 2022 
(22-4306) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  Spanish  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6.  
 
1. Notifying Member : NICARAGUA  
If applicable, name of local government involved (Articles 3.2 and 7.2):  
2. Agency responsible:  
Ministerio de Salud , MINSA (Ministry of Health)  
Autoridad Nacional de Regulación Sanitaria , ANRS (National Health Regulatory Authority)  
Name and address (including telephone and fax numbers, email and website 
addresses, if available) of agency or authority  designated to handle comments 
regarding the notification shall be indicated if different from above:  
Ministerio de Fomento, Industria y Comercio , MIFIC (Ministry of Development, Industry 
and Trade)  
Carretera a Masaya, Kilómetro 6, frente a Camino de Orien te. Managua, Nicaragua  
Email: imartinez@mific.gob.ni ; notificacion@mific.gob.ni ; normalizacion@mific.gob.ni ; 
Tel.: (+505) 2248 9300, Ext. 1320 ; 1314; 1310 
Website : www.mific.gob.ni   
3. Notified under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ], 3.2 [ ], 7.2 [ ], 
other:  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading . ICS numbers may be provided in addition, where applicable) : 
Pharmaceutical products (HS code : 30); Medicines ( ICS 11 .120.10)  
5. Title, number of pages and language(s) of the notified document : 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)  
6. Description of content : 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.  
7. Objective and rationale, including the nature of urgent p roblems where 
applicable : Protection of human health or safety  
8. Relevant documents:  
• Buenas Prácticas Clínicas : Documento de las Américas, Red Panamericana para 
la Armonización de la Reglamentación Farmacéutica -REDPARF -, Organización 
Panamericana de la Salud -OPS. 
• Reglamento del Comité Nacional de Investigación en Salud (CONIS).  G/TBT/N/NIC/172  
- 2 - 
  9. Proposed date of adoption : To be determined  
Proposed date of entry into force : The notified Nicaraguan Mandatory Technical 
Standard will ent er into force 180 days following its publication in the Official Journal La 
Gaceta . 
10. Final date for comments : 7 August 2 022 
11. Texts available from : National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:  
Ministerio de Fomento, Industria y Comercio , MIFIC (Ministry of Development, Industry 
and Trade)  
Dirección de Normalización y Metrología , DNM (Directorate of Standardization and 
Metrology ) 
Oficina de Información y Notificación , OIN (Information and Notification Office)  
Carretera a Masaya, Kilómetro 6, frente a Camino de Oriente . Managua, Nicaragua  
Tel.: (+505) 2248 9300, Ext. 1320 ; 1314; 1310 
Email: imartinez@mific.gob.ni ; notificacion@mific.gob.ni ; normalizacion@mific.gob.ni ; 
Website : www.mific.gob.ni/   
https://members.wto.org/crnattachments/2022/TBT/NIC/22_3963_00_s.pdf