. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/CRI/92 
3 June 2009 
 (09-2662) 
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, Dirección de Mejora 
Regulatoria y Reglamentación Técnica  (Ministry of the Economy, Industry and Trade, 
Regulatory Improvement and Technical Regulation Directorate) 
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: 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):   International 
Classification for Standards (ICS) code 11.120.99 
5. Title, number of pages and language(s) of the notified document:   RTCA 11.03.56:09, 
Productos Farmacéuticos.  Productos Natu rales Medicinales para Uso Humano.  
Verificación de la Calidad  (Central American Technical Regulation (RTCA) 
No. 11.03.56:09:  Pharmaceutical products.  Na tural medicines for human use.  Quality 
control) (8 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 natural medicines for human use.  The provisions of th is Regulation apply to all natural medicines 
for human use which are imported into or ma nufactured in Central American countries.  
The Regulation guidelines are mandatory for all natural medicines the pharmaceutical form 
of which is administered by any route other than ophthalmic or parenteral. 
7. Objective and rationale, including the nature of urgent problems where applicable:  
Prevention of practices likely to mislead the consumer and protection of human health.  G/TBT/N/CRI/92 
Page 2  
 
  8. Relevant documents:  
• Appendix XVI D, Microbiological quality of pharmaceutical preparations , British 
Pharmacopoeia, Volume IV. 2007. 
• The United States Pharmacopeia 30 and The National Formulary 25. 30th Edition.  The 
United States Pharmacopeial Convention Inc. USA. 2007. 
• Secretaría de Salud, Comisión Permanente de  la Farmacopea de los Estados Unidos 
Mexicanos  (Ministry of Health, Permanent Pharmacopoeia Commission of the United 
Mexican States), Farmacopea Herbolaria de los Estados Unidos Mexicanos  (Herbal 
Pharmacopoeia of the United Mexican States).  Mexico. 2001. 
• Arias, Tomas D., Glosario de Medicamentos:  Desarrollo, Evaluación y Uso  (Glossary 
of medicines:  development, evaluation and use), 1
st Edition.  Pan American Health 
Organization, USA. 1999. 
• García G., Mildred, Legislación en Iberoamérica sobre Fitofármacos y Productos 
Naturales  (Ibero-American legislation on phyt omedicines and natural products).  
Ibero-American Programme of Science and Technology for Development (CYTED).  
Costa Rica, 2000. 
• RTCA 67.04.50:08, Alimentos.  Criterios Microbiológicos para la Inocuidad de 
Alimentos  (Central American Technical Regulation (RTCA) No. 67.04.50:08:  Food 
products.  Microbiological criteria for food safety).  
9. Proposed date of adoption: 
Proposed date of entry into force:   Upon publication in the Official Journal, 
La Gaceta 
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, 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/cons ulta/rtca-16-20-0309.pdf
 
and http://members.wto.org/crnattach ments/2009/tbt/cri/09_1939_00_s.pdf