G/TBT/N/NIC/131  
16 August 2013  
(13-4417)  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 governme nt involved (Articles 3.2 and 7.2):   
2. Agency responsible:  Ministerio de Salud  (Ministry of Health) 
Name and address (including telephone and fax numbers and e-mail and 
website addresses, if available) of  agency or authority designated to handle 
comments regarding the notification shall be indicated if di fferent from above:  
Ministerio de Salud  (Ministry of Health) 
Dirección de Farmacias  (Directorate of Pharmacies) 
Tel.: (+505) 2289-4700, Ext. 217 Fax: (+505) 2289-4700, Ext. 115 
E-mail: mailto:div-far@minsa.gob.ni  or areadrogas@minsa.gob.ni  
Ministerio de Fomento, Industria y Comercio  (Ministry of Development, Industry 
and Trade) 
Centro de Información sobre Obstáculos Técnicos al Comercio  (TBT Enquiry Point) 
Tel.: (+505) 2248-9300, Ext. 2230 or 2276 Fax: (+505) 2248-9300, Ext. 2228 E-mail: nsolano@mific.gob.ni  or imartinez@mific.gob.ni  
3. Notified under Arti cle 2.9.2 [X], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], other:   
4. Products covered (HS or CCCN wher e applicable, otherwise national tariff 
heading. ICS numbers may be provid ed in addition, where applicable):  
International Classification for Standards (ICS) code 11.120.99 
5. Title, number of pages and lang uage(s) of the notified document:  Reglamento 
Técnico Centroamericano RTCA 11.03.69:13, Productos farmacéuticos. Productos 
naturales medicinales para uso humano. Buenas prácticas de manufactura (Central American Technical Regulation (RTCA) No. 11.03.69:13: Pharmaceutical 
products. Natural medicines for human use. Good Manufacturing Practices). 
6. Description of content:  The notified Technical Regulation establishes the principles 
and guidelines set forth in the Good Manufacturing Practices that regulate all procedures 
involved in the manufacture of natural medicines for human use, in order to assure the efficacy, safety and quality of such products. It applies to all laboratories manufacturing 
natural medicines for human use.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Quality assurance of natural medicines and protection of human health. G/TBT/N/NIC/131 
- 2 - 
  8. Relevant documents:  
RTCA 11.03.64:11, Reglamento Técnico Centroamericano de Productos Farmacéuticos. 
Productos Naturales Medicinales para uso humano. Requisitos de Registro Sanitario y sus 
posteriores actualizaciones  (Central American Technical Regulation (RTCA) 
No. 11.03.64:11, "Pharmaceutical products. Natural medicines for human use. Sanitary registration requirements" and subsequent updates thereto); 
RTCA 11.03.59:09, Reglamento Técnico Centroamericano de Productos Farmacéuticos. 
Verificación de la calidad de productos naturales. Productos Naturales Medicinales para uso humano y sus posteriores actualizaciones  (Central American Technical Regulation 
(RTCA) No. 11.03.59:09, "Pharmaceutical products. Quality control of natural products. 
Natural medicines for human use" and subsequent updates thereto); 
RTCA 11.04.41:06, Reglamento Técnico Centroamericano de Productos Farmacéuticos. 
Etiquetado de Productos Naturales. Productos Naturales Medicinales para uso Humano 
y sus posteriores actualizaciones  (Central American Technical Regulation (RTCA) 
No. 11.04.41:06, "Pharmaceutical products. Labelling of natural products. Natural medicines for human use" and subsequent updates thereto). 
9. Proposed date of adoption: 
Proposed date of entry into force:   To be determined. 
To be determined. 
10. Final date for comments:  60 days as from the date of notification. 
11. Texts available from: National enquiry point [X] or address, telephone and fax 
numbers and e-mail and website addresse s, if available, of other body: 
Ministerio de Fomento, Industria y Comercio 
Centro de Información sobre Obst áculos Técnicos al Comercio 
Tel.: (+505) 2248-9300, Ext. 2230 or 2276 
Fax: (+505) 2248-9300, Ext. 2228 
E-mail: nsolano@mific.gob.ni ; imartinez@mific.gob.ni  
Website: 
http://www.mific.gob.ni/QUEESELSISTEMAN ACIONALDELACALIDAD/SISTEMANACIONALD
ENORMALIZACION/NORMAST%C3%89CNICASENCONSULTAPUBLICA/tabid/351/language
/en-US/Default.aspx  
http://www.mific.gob.ni/QUEESELSISTEMAN ACIONALDELACALIDAD/SISTEMANACIONALD
ENORMALIZACION/NORMAST%C3%89CNICASENCONSULTAPUBLICA/tabid/351/language
/en-US/Default.aspx