. /.  WORLD TRADE  
ORGANIZATION   
G/TBT/N/HND/73 
7 February 2012 
 (12-0732) 
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:   HONDURAS 
If applicable, name of local government involved (Articles 3.2 and 7.2):  
2. Agency responsible:   Secretaria de Industria y Comercio  (Ministry of 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:  
Dirección General de Integraci ón Económica y Política Comercial  (Directorate-General of 
Economic Integration and Trade Policy) Boulevard José Cecilio del Valle Edificio San José, 3er piso 
Tegucigalpa Fax: (+504) 235-3082 / 235-5047 
E-mail: wduque@sic.gob.hn ;  gsalinas_sic@yahoo.com ;  roger.pineda@yahoo.com  
Website: http://www.sic.gob.hn/dgiepc/instrume ntos jurídicos/notificaciones de Honduras a 
la OMC 
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.  Natural medicines for human use.  Sanitary registration) 
(19 pages, in Spanish). 
6. Description of content:   The notified Technical Regula tion 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 le gal persons for marketing in the Central 
American region.  It does not apply to produc ts containing as the constituent responsible for 
pharmacological activity active substances that ar e chemically synthesized or isolated from 
natural material, or to ophthalmic or parenteral pharmaceutical products. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human health G/TBT/N/HND/73 
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 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: 
Secretaría de Salud 
Dirección General de Regulación Sanitaria 
Centro de Tegucigalpa Antiguo edificio BANMA Esquina opuesta a Farmacia Regis República de Honduras Fax: (+504) 2237-9404 and 2237-2726 
E-mail: normativorshn@yahoo.com  
 
Secretaría de Industria y Comercio Dirección General de Protección al Consumidor Departamento de Normalización 
Boulevard José Cecilio del Valle 
Edificio San José, 2do piso Tegucigalpa Fax: (+504) 2235-5006 E-mail: normalizacion@sic.gob.hn  and roger.pineda@yahoo.com  
Website: http://www.sic.gob.hn/dgiepc/instrume ntos jurídicos/notificaciones de Honduras 
a la OMC