G/TBT/N/NIC/159  
11 April 2019  
(19-2411) 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 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 ) 
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: http://www.mific.gob.ni/en -us/snc/snn/ntcpub/ntoncpub.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) : 11.120.01  
5. Title, number of pages and language(s) of the notified document : 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)  
6. Description of content : 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 S tandard applies to natural and legal persons established in 
Nicaragua and engaged in the manufacture, importation, distribution and marketing of 
vaccines 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/159  
- 2 - 
  8. Relevant documents:  
1. 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 ; 
2. Resolución No. 214-2007 (COMIECO XLVII) Reglamento Técnico Centroamericano 
RTCA 11.03.47:07 Verificación de la Calidad de Medicamentos para Uso Humano ; 
3. Resolución No. 256-2010 (COMIECO -LIX) Reglamento Técnico Centroamericano 
RTCA 11.01.04:10 Estudios de Estabilidad de Medicamentos para Uso Humano ; 
4. Resolución No. 333-2013 (COMIECO -LXVI) Reglamento Técnico Centroamericano 
RTCA 11.03.59:11 Requisitos de Registro Sanitario de Medicamentos para Uso 
Humano ; 
5. Resolución No. 340-2014 (COMIECO - LXVII) Reglamento Técnico 
Centroamericano RTCA 11.01.02:04 Etiquetado de Productos Farmacéuticos para 
Uso Humano , 
6. Resolución No. 339-2014 (COMIECO -LXVII) Reglamento Técnico 
Centroamericano RTCA 11.03.42:07 Buenas Prácticas de Manufactura para la 
Industria  Farmacéutica de Medicamentos para Uso Humano ; 
7. Guidelines on stability evaluation of vaccines, WHO/BS/06.2049;  
8. Guidelines on non -clinical evaluation of vaccines, WHO Technical Report Series 
927, 2005, or the guidelines in effect at the time;  
9. Guidelines on the non -clinical evaluation of vaccine adjuvants and adjuvanted  
vaccines (WHO TRS 987, Annex 2);  
10. Guidelines on clinical evaluation of vaccines : regulatory expectations, WHO 
Technical Report Series 1004, Annex 9, 2017, or the guidelines in effect at the 
time, and specific WHO guidelines for the type of vaccine concerned.  
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 the date of notification  
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  
Km 6 Carretera a Masaya  
Managua, Nicaragua  
Tel.: (+505) 2248 -9300, Ext. 1314 o r 1310  
Email: notificacion@mific.gob.ni ; normalizacion@mific.gob.ni  
imartinez@mific.gob.ni  
Website: http://www.mific.gob.ni/en -us/snc/snn/ntcpub/ntoncpub.aspx