. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/HND/44 
25 July 2007 
 (07-3182) 
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:  REPUBLIC OF 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 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, 4to piso 
Tegucigalpa 
Telefax: (+504) 235-3082 / 235-5047 E-mail: pcomercial@sic.gob.hn Website: www.sic.gob.hn 
 Notified under Article 2.9.2 [  X ], 2.10.1 [   ], 5.6.2 [ X ], 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 11.03.47:07: 
Productos Farmacéuticos. Medicamentos para uso humano. Verificación de la Calidad  
(Central American Technical Regulation (R TCA) No. 11.03.47:07:  Pharmaceutical 
products.  Medicines for human use.  Qua lity control)  (9 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 medicines.  
 The provisions of this Regulation apply to all medicines imported into or 
manufactured in Central American countries. 
7. Objective and rationale, including the nature of urgent problems where applicable:    
 Protection of human health. 
 
 
 G/TBT/N/HND/44 
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8. Relevant documents:    
Arias, T.D., Glosario de Medicamentos: Desarrollo, Evaluación y Uso  (Glossary of 
medicines:  development, evaluation and use). Pan American Health Organization, 
Washington, D.C., PAHO. 1999. 
United States Pharmacopeia 30 - National Formulary 25 .  Thirtieth edition.  The United 
States Pharmacopeial Convention Inc. USA. 2007. 
9. Proposed date of adoption:  Upon publication in the Official Journal  
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:    
Secretaria de Salud 
Dirección General de Regulación Sanitaria Centro de Tegucigalpa Antiguo edificio BANMA 
Esquina opuesta a Farmacia Regis 
Telefax:  +(504) 237-2726 / 237-9404 E-mail: regulacionhon@yahoo.com   Dirección General de Producción y Consumo 
Boulevard José Cecilio del Valle 
Edificio San José, 3er piso Tegucigalpa Telefax: (+504) 235-5006 E-mail: normalizacion@sic.gob.hn Website: www.sic.gob.hn