. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/CRI/88 
1 May 2009 
 
 (09-2139) 
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:   COSTA RICA
 
If applicable, name of local government involved (Articles 3.2 and 7.2):    
2. Agency responsible:    
Ministerio de Economía, Industria y Comercio , MEIC (Ministry of the Economy, Industry 
and Trade) 
Dirección de Mejora Regulatoria y Reglamentación Técnica  (Regulatory Improvement and 
Technical Regulation Directorate) 
Tel.: +(506) 2235-2700, ext. 264, or +(506) 2297-1439 
Name and address (including telephone and fax numbers, 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:  
TBT Enquiry Point 
Ministry of the Economy, Industry and Trade, MEIC Apartado Postal 10216-1000, San José Tel.:  (+506) 2235-2700, ext. 264 Fax:  (+506) 2297-1439  E-mail:  crotc@meic.go.cr  
Website: www.reglatec.go.cr
 
3. Notified under Article 2.9.2 [  X ], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other:   Transparency. 
On 4 October 2006, the Government of Costa Rica notified the following draft Technical 
Regulation in document G/TBT/N/CRI/53 unde r the Central American Customs Union 
agreements.  The Regulation was eventually not adopted.  Given that Costa Rica lacks this 
type of legislation, it is being issued as a domestic regulation. 
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:   RTCR 431:2009: 
Productos Farmacéuticos. Medicamentos de  Uso Humano. Buenas Prácticas de 
Manufactura para la Industria Farmacéutica  (Costa Rican Technical Regulation (RTCR) 
No. 431:2009:  Pharmaceutical products.  Me dicines for human use.  Good manufacturing 
practices for the pharmaceutical industry) (68 pages, in Spanish). G/TBT/N/CRI/88 
Page 2  
 
  6. Description of content:   The notified Technical Regulation establishes the principles and 
guidelines for the Good Manufacturing Practices  (GMPs) governing all procedures involved 
in the manufacture of pharmaceuticals in order to ensure their effectiveness, safety and 
quality. 
7. Objective and rationale, including the natu re 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; 
- Arias, Tomas D., Glosario de Medicamentos: desarrollo, evaluación y uso  (Glossary of 
medicines:  development, evaluation and u se).  Pan American Health Organization, 
Washington, D.C., PAHO, c1999, 333p; 
- Reglamento de Buenas Prácticas de M anufactura para Laboratorios de Productos 
Farmacéuticos de Uso Humano.  Ministerio de Salud Pública y Asistencia Social, 
Departamento de Regulación y Control de  Productos Farmacéuticos y Afines (Good 
Manufacturing Practice (GMP) Regulation for laboratories manufacturing pharmaceuticals for human use.  Ministry of  Public Health and Social Welfare, 
Department for the Regulation and Control of Pharmaceutical and Related Products). 
Guatemala, March 2004; 
- Good manufacturing practices .  The rules governing medicinal products in the 
European Union , Vol. 4., European Commission, 1999 edition. 
9. Proposed date of adoption:   
 Proposed date of entry into force:    Upon publication in the Official Journal, 
La Gaceta 
Six months after publication in the Official 
Journal  
10. Final date for comments:   Not applicable 
11. Texts available from:  National enquiry point [  X ] or address, telephone and fax 
numbers, E-mail and website addresses,  if available, of other body: 
WTO TBT Enquiry Point 
San José, Costa Rica 
Tel.:  (+506) 2235-2700, Ext. 264 
Fax:  (+506) 2297-1439  E-mail: crotc@meic.go.cr
  
Website: http://www.reglatec.go.cr  
 
The full text of the Regulation is available at:  
http://www.reglatec.go.cr/consulta/rtc-431-2009.pdf  
and  http://members.wto.org/crnattach ments/2009/tbt/cri/09_1478_00_s.pdf