. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/CRI/53 
4 October 2006 
 (06-4758) 
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 COSTA RICA
 
If applicable, name of local government involved (Articles 3.2 and 7.2):    
2. Agency responsible:   Ministerio de Economía, Industria y Comercio, Órgano de 
Reglamentación Técnica , (Ministry of the Economy, Industry and Trade, Technical 
Regulation Body) Tel. no +(506) 235 2700, ext. 206/203 or  +(506) 297 1439 
Name and address (including telephone and fax numbers, e-mail and web-site 
addresses, if available) of  agency or authority designated to handle comments 
regarding the notification shall be  indicated if different from above:    
Centro de Información de Obst áculos Técnicos al Comercio 
Ministerio de Economía, Industria y Comercio- MEIC Apartado Postal. 10216-1000 
 
Tel.:  (+506) 235-2700, ext. 206/203 Fax:  (+506) 297-1439 E-mail:  crotc@meic.go.cr  Web site: http://www.reglatec.go.cr 
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 applicable, otherwise national tariff heading.  
ICS numbers may be provided in  addition, where applicable):   ICS 11.120.99 
5. Title, number of pages and language(s) of the notified document:   RTCA 11.04.42:06 
Productos Farmacéuticos, Medicamentos de  Uso Humano, Buenas Prácticas de 
Manufactura para la Industria Farmacéutica  (Pharmaceutical products.  Medicines for 
human use.  Good manufacturing practices for the pharmaceutical industry) (69 pages, in 
Spanish). 
6. Description of content:  
 These technical regulations determine the principles and guidelines for good 
manufacturing practices and regulate all procedures involved in the manufacture of pharmaceuticals for human use in order to ensure  their effectiveness, safety and quality. 
 They apply to laboratories manufactur ing pharmaceutical products in Central 
American countries.  G/TBT/N/CRI/53 
Page 2  
 
  7. Objective and rationale, including the nature of urgent problems where applicable:  
 Protection of human life and health. 
8. Relevant documents:  
- Thirty second report.  Technical report series 823, WHO Expert Committee on 
Specifications for Pharmaceutical Preparations, Geneva, 1992. 
- Guidelines for 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 Diario Oficial  (Official 
Journal) 
To be determined 
10. Final date for comments:   Sixty days as from the date of notification. 
11. Texts available from:  National enquiry point [  X ] or address, telephone and fax 
numbers, e-mail and web-site addresses, if available of the other body:  Responsible: 
TBT Enquiry Point 
Web site:  http://www.reglatec.go.cr WTO contact:  crotc@meic.go.cr San José, Costa Rica 
Tel.:   (+506) 235 2700, Ext. 221 or 203 
Fax:   (+506) 297 1439 or (+506) 236 7192 
The full text of the document is available at: http://www.reglatec.go.cr/descargas/RTCA_11.04. 42.06_BPMparalaindus triadeMedicamen
tos.pdf