G/TBT/N/HND/81  
15 August 2013  
(13-4382)  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:  HONDURAS 
If applicable, name of local governme nt 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 Integración Económica y Política Comercial  (Directorate-General 
of Economic Integration and Trade Policy) 
Secretaria de Industria y Comercio  (Ministry of Industry and Trade) 
Boulevard José Cecilio del Valle 
Edificio San José, 3er piso 
Tegucigalpa Telefax: (+504) 2235-3078 / 2235-5047 
E-mail: yulissa_santos@yahoo.com ; gsalinas_sic@yahoo.com  
Website: http://www.sic.gob.hn/dgiepc/ notificaciones-de-hond uras-a-la-o.m.c..html  
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 where applicable, otherwise national tariff 
heading. ICS numbers may be provided  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:  
RTCA 11.03.69:13, Productos Farmacéuticos. Productos Naturales Medicinales de 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) (51 pages, in Spanish). 
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. 
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health. 
8. Relevant documents:  
- Proyecto de RTCA Reglamento Técnico Centroamericano de Productos Farmacéuticos. 
Medicamentos de Uso Humano. Buenas Prácticas de Manufactura para la Industria 
Farmacéutica  (Draft Central American Technical Regulation on pharmaceutical 
products. Medicines for human use. Good manufacturing practices for the pharmaceutical industry). 
- WHO guidelines on good manufacturing practices (GMP) for herbal medicines, 2007. G/TBT/N/HND/81 
- 2 - 
  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: 
 
Secretaría de Salud 
Dirección General de Regulación Sanitaria Centro de Tegucigalpa 
Antiguo edificio BANMA, 
Esquina opuesta a Farmacia Regis Tegucigalpa 
Telefax: (+504) 2237-9404 and 2237-2726 
E-mail: geralfaro2000@yahoo.com ; fciamirta_37@yahoo.com   
 
Dirección General de Integración Económica y Política Comercial 
Secretaría de Industria y Comercio 
Boulevard José Cecilio del Valle Edificio San José, 3er Piso 
Tegucigalpa 
Telefax: (+504) 2235-3078 / 2235-5047 E-mail: gsalinas_sic@yahoo.com ; roger.pineda@yahoo.com   
 
Full text available at: http://www.sic.gob.hn/dgiepc/ notificaciones-de-hond uras-a-la-o.m.c..html   
http://members.wto.org/crnattachments/2013/tbt/HND/13_3237_00_s.pdf