. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/NIC/79 
3 October 2006 
 
 (06-4736) 
Committee on Technical Barriers to Trade Original:   Spanish 
  
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6. 
 
1. Member to Agreement notifying:  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) 
División de Farmacia  (Department of Pharmacy) 
Tel.:  289 4401 Fax:  289 4401 
E-mail:  div-far@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 applic able, otherwise national tariff heading.  
ICS numbers may be provided in  addition, where applicable):   ICS Code 11.120.99 
5. Title, number of pages and language(s) of the notified document:  Nicaraguan 
Mandatory Technical Standard (NTON) 19 004- 06/Central American Technical Regulation 
(RTCA) 11.04.41:06 Productos Naturales de Uso Humano. Productos Naturales con 
Porpiedades Medicinales.  Etiquetado de Productos Naturales  (Natural Products for Human 
Use.  Products with Medicinal Properties.  Labelling of Natural Products) (7 pages, in 
Spanish). 
6. Description of content:   The purpose of this technical regulation is to establish minimum 
requirements for the labelling of natural products  for human use, as regards both products 
from the territory of the Central Am erican countries and imported products. 
 This technical regulation applies to the labelling of all natural products for human 
use, irrespective of the terms and conditions of sal e, shipping or supply.  It does not apply to 
products containing as constituent responsible for pharmacological activity standardized 
natural material or material that is chemically  synthesized or isolated from natural material, 
since they are not considered to be natural products. 
7. Objective and rationale, including the nature of urgent problems where applicable: 
 Protection of human life and health and consumer protection. G/TBT/N/NIC/79 
Page 2  
 
  8. Relevant documents:   RTCA 11.01.02:03 Reglamento Técnico  Productos Farmacéuticos. 
Etiquetado de productos farmacéuticos para uso humano  (Technical Regulation for 
Pharmaceutical Products.  Labelling of Ph armaceutical Products for Human Use). 
9. Proposed date of adoption:  
Proposed date of entry into force:  Upon publication in the Official Journal 
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) 267-0161, ext. 1130 or 1048 
Fax: (+505) 270-9956 E-mail: valeria.pineda@mific. gob.ni or dtnm@mific.gob.ni