. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/HND/38 
3 October 2006 
 (06-4723) 
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  (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 
Fax: (+504) 235 3082/235 5047 
E-mail: pcomercial@sic.gcb.hm Web site: www.sic.gob.hn
 
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):   International 
Classification fo r Standards (ICS) code 11.120.99 
5. Title, number of pages and language(s) of the notified document:   RCTA 11.04.42:06 
Productos Farmacéuticos.  Medicamentos de  Uso Humano.  Buenas Prácticas de 
Manufactura para la Industria Farmacéutica  (Central American Technical Regulation 
(RTCA) No. 11.04.42:06:  Pharmaceutical products.  Medicines for Human Use.  Good 
Manufacturing Practices for the Pharmaceutical Industry) (69 pages, in Spanish). 
6. Description of content:   This Technical Regulation establishes the principles and 
guidelines set forth in the Good Manufacturing Practices that regulate all procedures 
involved in the manufacture of pharmaceutical products, in order to assure the efficacy, safety and quality of such products.  This Re gulation applies to laboratories manufacturing 
pharmaceutical products in Ce ntral American countries. 
7. Objective and rationale, including the nature of urgent problems where applicable: 
 Protection of human health and life. G/TBT/N/HND/38 
Page 2  
 
  8. Relevant documents:  
 
 Thirty-Second Report. Technical report series 823, WHO Expert Committee on Specifications for Pharmaceutical Preparations, Geneva 1992. 
 Guía de inspección y auto inspección de Bu enas Practicas de Manufactura para la 
Industria Farmacéutica  (Guidelines for the inspection and self-inspection of Good 
Manufacturing Practices for the Pharmaceutical Industry) in Central American countries. 
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:  
Secretaria de Salud 
Dirección General de Regulación Sanitaria Centro de Tegucigalpa 
antiguo edificio BANMA 
esquina opuesta a Farmacia Regis Fax:  (+504) 237 2726 E-mail: regulacionhon@yahoo.com  Dirección General Producción y Consumo 
Boulevard José Cecilio del Valle 
Edificio San José 3er piso Fax: (+504) 235 5006 E-mail: normalizacion@sic.gob.hn 
Web site: www.sic.gob.hn