G/TBT/N/NIC/162  
18 June 2020 
(20-4286) Page: 1/3 
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.: (+505) 2289 -4700, Ext.1005, or 2289 -4401 
Email: dgrs@minsa.gob.ni ; farmaciadir@minsa.gob.ni  
Name and address (including telephone and fax numbers, email and website 
addresses, if availa ble) 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)  
Km 6 Carretera a Masaya  
Managua, Nicaragua  
Tel.: (+505) 2248 -9300, Ext. 1314 or 1310  
Email: notificacion@mific.gob.ni ; normalizacion@mific.gob.ni ; imartinez@mific.gob.ni  
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) : ICS 
11.120.01  
5. Title, number of pages and language(s) of the notified document:  NTON 19 013 - 
20 Medicamentos De Uso Humano. Productos de Origen Biológico y Biosimilares. 
Requisitos de Registro  (Nicaraguan Mandatory Technical Standard (NTON) No. 19 013 -
20: Medicines for human use . Products of biological origin and biosimilars . Registration 
requirements) (60 pages, in Spanish)  
6. Description of content : The notified Technical Standard establishes the requirements 
governing the registration of biological products and biosimilars for human use, the 
renewal of and changes to sanitary registration, and the batch release of such biological 
products, based on a risk assessment.  
It applies to natural and legal persons engaged in the manufacture, impor tation, 
distribution and marketing of biological products and biosimilars for human use.  
7. Objective and rationale, including the nature of urgent problems where 
applicable : Protection of human life and health  G/TBT/N/NIC/162  
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  8. Relevant documents:  
1. Resolución Ministeri al 212 -2016, MINSA Procedimiento para la verificación de la 
calidad de medicamentos de uso humano en la etapa de post comercialización ; 
2. Resolución Ministerial 213 -2016 MINSA Adenda al Procedimiento para la 
verificación de la calidad de medicamentos de uso humano en la etapa de post 
comercialización ; 
3. Resolución No. 188-2006 (COMIECO XL) que aprueba el Reglamento Técnico 
Centroamericano . Productos Farmacéuticos . Validación de métodos analíticos 
para la evaluación de la calidad de los medic amentos (N TON 19  003 - 06/RTCA 
11.03.39:06) ; 
4. Resolución No. 214-2007 (COMIECO XLVII) que aprueba el Reglamento Técnico 
Centroamericano . Verificación de la Calidad de los Medicamentos para Uso 
Humano (N TON 19  006 - 06/RTCA 11 .03.47:07) ; 
5. Resolución No. 148-2005 (COMIECO XXXIII) que aprueba el Reglamento Técnico 
Centroamericano . Primera actualización Productos Farmacéuticos . Estudios de 
Estabilidad de Medicamentos para uso humano (N TON 19  002 - 10/ R TCA 
11.01.04:10) ; 
6. 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) ; 
7. International Conference on Harmonization (ICH) Guidelines on Stability Testing . 
Guideline Q5C, Quality of Biotechno logical Products : Stability Testing of 
Biotechnological/Biological Products;  
8. ICH Guideline S6, Biotechnological Products . Preclinical Safety Evaluation of 
Biotechnological -Derived Pharmaceuticals;  
9. WHO Requirements for the collection, processing and quality control of blood, 
blood components and plasma derivatives . WHO Technical Report Series No. 840, 
Annex 2 (adopted by the WHO Expert Committee on Biological Standardization in 
1992);  
10. ICH Guidelines on Stability Testing . Guideline Q5C, Quality of Biot echnological 
Products : Stability Testing of Biotechnological/Biological Products;  
11. Guidelines on evaluation of similar Biotherapeutic Products (SBPs), Annex 2, 
Technical Report Series No. 977, 2013;  
12. Guidelines on evaluation of monoclonal antibodies as simil ar biotherapeutic 
products (SBPs), Annex 2, Technical Report Series No. 1004, 2016;  
13. ICH Guideline S6, Biotechnological Products . Preclinical Safety Evaluation of 
Biotechnological -Derived Pharmaceuticals;  
14. ICH Guideline M3 (R2), Guidance on non -clinical safe ty studies for the conduct of 
human clinical trials and marketing authorization for pharmaceuticals;  
15. WHO Good Clinical Practices : Document of the Americas;  
16. ICH Quality Guidelines (Q1, Q2, Q3, Q4, Q5 and Q6) and ICH Guideline M10 : 
Bioanalytical Method Valid ation;  
17. "Manual para el Procedimiento de Registro de Productos Biológicos y Biosimilares 
de Uso Humano" ; 
18. WHO guidelines for good clinical practice (GCP).  
9. Proposed date of adoption : To be determined  
Proposed date of entry into force : To be determined  
10. Final date for comments : 60 days from notification  G/TBT/N/NIC/162  
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  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  (Ministry of Development, Industry and 
Trade)  
Km 6 Carretera a Masaya  
Managua, Nicaragua  
Tel.: (+505) 2248 9300, Ext. 1314 or 1310  
Email: notificacion@mific.gob.ni ; normalizacion@mific.gob.ni ; imartinez@mific.gob.ni  
Website: https://www.mific.gob.ni/Comercio -Interior/Normalizaci%C3%B3n -y-
Metrolog%C3%ADa/Normas -en-Consulta -P%C3%BAblica/NTON -en-Consulta -
P%C3%BAblica  
https://www.mific.gob.ni/Portals/0/Documentos/Comercio%20Interior/ Documentos%20
DNM/NORMALIZACION/NORMAS%20EN%20CONSULTA%20PUBLICA/NACIONAL/2020/2
020-06-10/GIC%20NT%20035%20ENN%20 -%2020001%20CP.pdf?ver=2020 -06-16-
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