. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/HND/31 
2 August 2006 
 (06-3713) 
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) 235-5057  
E-mail: pcomercial@sic.gob.hn 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 for Standards (ICS) code  11.120.01 
5. Title, number of pages and language(s) of the notified document:   RTCA 11.01.35:06: 
Productos Farmacéuticos.  Validación de Mét odos Analíticos para la Evaluación de la 
Calidad de los Medicamentos   (Central American Technical Regulation (RTCA) 
No. 11.01.35:06:  Pharmaceutical products.  Validation of the analytical methods for 
assessing the quality of medicines) (9 pages, in Spanish). 
6. Description of content:   The notified Technical Regulation seeks to establish the 
guidelines for validating the physico-chemical and microbiological analytical methods 
(official and unofficial) used to control the quality of medicines. 
7. Objective and rationale, including the nature of urgent problems where applicable:    
 Protection of human life and health  G/TBT/N/HND/31 
Page 2  
 
  8. Relevant documents:  
Text on Validation of Analytical Procedures .  International Conference on Harmonisation 
(ICH) guidance Q2A.  March 1995; 
Validation of Analytical Procedures:  Methodology . ICH-Q2B. May 1997; 
Validation of Compendial Methods . General Chapter <1225>, US  Pharmacopeia 27, United 
States Pharmacopeial Convention,  Inc., Rockville MD.  2004; 
International Organization for Standardi zation (ISO)/International Electrotechnical 
Commission (IEC) Standard No. 17025:2000:  General requirements for the competence of 
testing and calibration laboratories ; 
The Fitness for Purpose of Analytical Methods .  A Laboratory Guide to Method Validation 
and Related Topics .  EURACHEM Guide. Editor:  H. Holcombe, Laboratory of the 
Government Chemist (LGC), Teddington.  1998. 
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 
Tegucigalpa 
Telefax:  +(504) 237-2726 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  Web site: www.sic.gob.hn