. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/HND/58 
8 May 2009 
 (09-2267) 
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:  HONDURAS
 
If applicable, name of local government involved (Articles 3.2 and 7.2):   
2. Agency responsible:   Secretaría de Industria y Comercio , SIC (Ministry of Industry and 
Trade) 
Name and address (including telephone and fax numbers and E-mail and Website 
addresses, if available) of agency or au thority 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, 4to piso Tegucigalpa 
Telefax: (+504) 235-5047 / 235-3082 
E-mail: wduque@sic.gob.hn Website: http://www.sic.gob.hn
 
 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 11.120.99 
5. Title, number of pages and language(s) of the notified document:   RTCA 11.03.56:09, 
Productos Farmacéuticos.  Productos Natu rales Medicinales para Uso Humano.  
Verificación de la Calidad  (Central American Technical Regulation (RTCA) 
No. 11.03.56:09:  Pharmaceutical products.  Na tural medicines for human use.  Quality 
control) (8 pages, in Spanish). 
6. Description of content:  The notified Technical Regulation establishes the analytical tests 
which must be carried out by the regulatory authority to verify the quality of natural medicines for human use.  The provisions of this Regulation apply to all natural medicines for human use which are imported into or ma nufactured in Central American countries.  
The Regulation guidelines are mandatory for a ll natural medicines the pharmaceutical form 
of which is administered by any route other than ophthalmic or parenteral. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Prevention of practices likely to mislead the consumer and protection of human health. G/TBT/N/HND/58 
Page 2  
 
  8. Relevant documents: 
• Appendix XVI D, Microbiological quality of pharmaceutical preparations , British 
Pharmacopoeia, Volume IV. 2007. 
• The United States Pharmacopeia 30 and The National Formulary 25. 30th Edition.  The 
United States Pharmacopeial Convention Inc.  USA. 2007. 
• Secretaría de Salud, Comisión Permanente de  la Farmacopea de los Estados Unidos 
Mexicanos  (Ministry of Health, Permanent Pharmacopoeia Commission of the 
United Mexican States), Farmacopea Herbolaria de lo s Estados Unidos Mexicanos  
(Herbal Pharmacopoeia of the Unite d Mexican States).  Mexico. 2001. 
• Arias, Tomas D., Glosario de Medicamentos:  Desarrollo, Evaluación y Uso  (Glossary 
of medicines:  development, evaluation and use), 1
st Edition.  Pan American Health 
Organization, USA. 1999. 
• García G., Mildred, Legislación en Iberoamérica sobre Fitofármacos y Productos 
Naturales  (Ibero-American legislation on phyt omedicines and natural products). 
Ibero-American Programme of Science a nd Technology for Development (CYTED).  
Costa Rica, 2000. 
• RTCA 67.04.50:08, Alimentos.  Criterios Microbiológicos para la Inocuidad de 
Alimentos  (Central American Technical Regul ation (RTCA) No. 67.04.50:08:  Food 
products.  Microbiological criteria for food safety).  
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:  
The full text of the Regulation is available from: 
 
Secretaria de Salud Dirección General de Regulación Sanitaria Centro de Tegucigalpa Antiguo edificio BANMA Esquina opuesta a Farmacia Regis 
Tegucigalpa, República de Honduras 
Telefax: (+504) 237-9404 and 237-2726 E-mail: regulacionhon@yahoo.com
 
 Secretaria de Industria y Comercio 
Dirección General de Producción y Consumo 
Departamento de Normalización Boulevard José Cecilio del Valle Edificio San José, 3er piso Tegucigalpa, República de Honduras 
Telefax: (+504) 235-5006 
E-mail: normalizacion@sic.gob.hn Website: http://www.sic.gob.hn