. /.  WORLD TRADE  
ORGANIZATION   
G/TBT/N/NIC/119 
14 February 2012 
 (12-0837) 
Committee on Technical Barriers to Trade Original: Spanish 
  
 
NOTIFICATION 
 
The following notification is being circ ulated 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 Fomento, Industria y Comercio  (Ministry of 
Development, Industry and Trade) 
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 different 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  
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):   International 
Classification for Standards (ICS) code:  11.120.10 
5. Title, number of pages and language(s) of the notified document:   RTCA 11.03.64:11, 
Productos Farmacéuticos.  Productos Natural es Medicinales para uso humano.  Registro 
Sanitario  (Central American Technical Regulation (RTCA) No. 11.03.64:11:  
Pharmaceutical products.  Natu ral medicines for human use.   Sanitary registration) 
(19 pages, in Spanish). 
6. Description of content:   The notified Technical Regulation establishes the conditions and 
requirements for the sanitary registration of natural medicines for human use intended for 
marketing.  The Regulation applies to na tural medicines for human use that are 
manufactured or imported by natural or  legal persons for marketing in the 
Central American region.  It does not a pply to products containing as the constituent 
responsible for pharmacological activity active substances that are chemically synthesized 
or isolated from natural material, or to opht halmic or parenteral pharmaceutical products. 
7. Objective and rationale, including the nature of urgent problems where applicable:  
Protection of human health. G/TBT/N/NIC/119 
Page 2  
 
  8. Relevant documents:  
(a) RTCA Productos Farmacéuticos.  Produc tos Naturales Medicinales para uso 
humano.  Requisitos de Etiquetado  (Central American Technical Regulation on 
Pharmaceutical products.  Natural me dicines for human use.  Labelling 
requirements) - in force; 
(b) RTCA Productos Farmacéuticos.  Produc tos Naturales Medicinales para uso 
humano.  Verificación de la Calidad (Central American Technical Regulation on 
Pharmaceutical products.  Natural medicines for human use.  Quality control) - in 
force. 
9. Proposed date of adoption: 
Proposed date of entry into force:  }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 addresses, if available, of other body: 
Ministerio de Fomento, Industria y Comercio 
Centro de Información sobre Obstáculos 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