G/TBT/N/NIC/168  
11 January  2021 
(21-0368) 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  (Ministry of Health)  
Dirección General de Regulación Sanitaria , DGRS (Directorate -General of Health 
Regulation)  
Direccion de Farmacia  (Pharmacy Directorate)  
Conchita Palacios, Costado Oeste Colonia Primero de mayo.  
Tel.: 2289-4700, Ext. 1005, 2289 -4401 
Email: dgrs@minsa.gob.ni ; farmaciadir@minsa.gob.ni  
Name and address (including telephone and fax numbers, email and website 
addresses, if availabl e) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:  
Ministerio de Fomento, Industria y Comercio  (Ministry of Development, Industry and 
Trade)  
Address : Kilómetro 6 de Carrera a Masaya, frente a Camino de Oriente  
Tel.: (+505) 2248 9300 Ext. : 1314, 1310  
Email: normalizacion@mific.gob.ni  imartinez@mific.gob.ni  
Website: http://www.mific.gob.ni/es -ni/snc.aspx  
3. Notified under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ], other:  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading . ICS numbers may be provided in addition, where applicable) : 
Pharmaceutics in general ( ICS 11 .120.01)  
5. Title, number of pages and language(s) of the notified document : NTON 19  014 - 
20 Productos Farmacéuticos . Medicamentos de uso Humano . Bioequivalencia e 
intercambiabilidad (Nicaraguan Mandatory Technical Standard (NTON) No. 19 014 - 20 
Pharmaceutical products . Medicines for human use . B ioequivalence and 
interchangeability) (44 pages, in Spanish)  
6. Description of content : The notified Technical Standard establishes the therapeutic 
equivalence guidelines to be met by multi -origin medicines in order to carry out the 
sanitary registration procedure.  
These guidelines supplement the requirements established in the version of Nicarag uan 
Mandatory Technical Standard (NTON)/Central American Technical Regulation (RTCA) 
Pharmaceutical products . Medicines for human use . Sanitary registration requirements, 
currently in force.  
They apply to all multi -origin pharmaceutical products that requi re proof of therapeutic 
equivalence according to a prioritized list based on sanitary risk criteria.  G/TBT/N/NIC/168  
- 2 - 
  7. Objective and rationale, including the nature of urgent problems where 
applicable : Protection of human health or safety  
8. Relevant documents:  
• Reglame nto Técnico Centroamericano R TCA 11 .03.59:11 Requisitos de Registro 
Sanitario de Medicamentos para Uso Humano - Resolución 333 -2013 (COMIECO 
- LXVI) ; 
• Good Clinical Practices : Document of the Americas, Pan American Network on 
Drug Regulatory Harmonization (PANDRH) - Pan American Health Organization 
(PAHO);  
• Resolución No. 148-2005 (COMIECO XXXIII) que aprueba el Reglamento Técnico 
Centroamericano . Primera actualización Productos F armacéuticos . Estudios de 
Estabilidad de Medicamentos para uso humano (N TON 19  002 - 10/ R TCA 
11.01.04:10) ; 
• Resolución No. 340-2014 (COMIECO LXVII) que aprueba el Reglamento Técnico 
Centroamericano . Etiquetado de Productos Farmacéuticos para Uso  Humano. 
(NTON 19  001 - 05/RTCA 11 .01.02:04) ; 
• Resolución No. 339-2014 (COMIECO -LXVII) Reglamento Técnico 
Centroamericano R TCA 11 .03.42:07 Buenas Prácticas de Manufactura para la 
Industria Farmacéutica de Medicamentos para Uso Humano ; 
• Resolución No. 188-2006 (COMIECO XL) Reglamento Técnico Centroamericano 
RTCA 11 .03.39:06 Validación de Métodos Analíticos para la Evaluación de la 
Calidad de los Medicamentos para Uso Humano ; 
• Resolución No. 214-2007 (COMIECO XLVII) Reglamento Técnico Centroamericano 
RTCA 11 .03.47:07 Verificación de la Calidad de Medicamentos para Uso Humano ; 
• Multisource (generic) pharmaceutical products : guidelines on registration 
requirements to establish interchangeability . In: WHO Expert Committee on 
Specifications for Pharmaceutical Products : fortieth report . World Health 
Organization : Geneva ; 2006: Annex 7 (WHO Technical Report Series, No. 992);  
• Norma para la Regulación de Ensayos Clínicos de Medicamentos en Seres 
Humanos en Nicaragua . 
9. Proposed date of adoption : To be determined  
Proposed date of entry into force : To be determined  
10. Final date for comments : 20 February 2 021 
11. Texts available from : National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:  
Ministerio de Fomento, Industria y Comercio  
(+505) 2248 9300, Ext. 1314 or 1310  
notificacion@mific.gob.ni ; normalizacion@mific.gob. ni; imartinez@mific.gob.ni  
http://www.mific.gob.ni/en -us/snc.aspx   
https://members.wto.org/crnattachments/2021/TBT/NIC/21_0330_00_s.pdf