. /.  WORLD TRADE  
ORGANIZATION   
G/TBT/N/CRI/131 
13 February 2012 
 (12-0819) 
Committee on Technical Barriers to Trade Original: Spanish 
  
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6. 
 
1. Notifying Member:   COSTA RICA 
If applicable, name of local government involved (Articles 3.2 and 7.2):   
2. Agency responsible:   Ministerio de Economía, Industria y Comercio  (Ministry of the 
Economy, Industry and Trade) Departamento de Reglamentación Técnica  (Technical Regulation Department) 
Tel.:  (+506) 2291-2115, Ext. 206, or (+506) 2291-2015 
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) 2291-2115, Ext. 206 
Fax:  (+506) 2291-2015 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 11.120.10 
5. Title, number of pages and language(s) of the notified document:   RTCA 11.03.64:11, 
Productos Farmacéuticos.  Productos Natural es Medicinales para uso humano.  Registro 
Sanitario  (Central American Technical Regulation (RTCA) No. 11.03.64:11:  
Pharmaceutical products.  Natural medicines for human use.  Sanitary registration) 
(19 pages, in Spanish). 
6. Description of content:   The notified Technical Regulation establishes the conditions and 
requirements for the sanitary registration of natural medicines for human use intended for 
marketing.  The Regulation applies to na tural medicines for human use that are 
manufactured or imported by natural or legal pe rsons for marketing in the Central American 
region.  It does not apply to products containing as the constituent responsible for 
pharmacological activity active substances that ar e chemically synthesized or isolated from 
natural material, or to ophthalmic or parenteral pharmaceutical products. G/TBT/N/CRI/131 
Page 2  
 
  7. Objective and rationale, including the nature of urgent problems where applicable:  
Protection of human health. 
8. Relevant documents:  
(a) RTCA Productos Farmacéuticos.  Productos Naturales Medicinales para uso 
humano.  Requisitos de Etiquetado  (Central American Technical Regulation on 
Pharmaceutical products.  Natural me dicines for human use.  Labelling 
requirements) - in force; 
(b) RTCA Productos Farmacéuticos.  Productos Naturales Medicinales para uso 
humano.  Verificación de la Calidad (Central American Technical Regulation on 
Pharmaceutical products.  Natural medicines for human use.  Quality control) - in 
force. 
9. Proposed date of adoption: 
Proposed date of entry into force:  } 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 the other body: 
TBT Enquiry Point 
Ministerio de Economía, Industria y Comercio, MEIC 
Apartado Postal 10216-1000 
San José, Costa Rica Tel.: (+506) 2291-2115, Ext. 206 Fax: (+506) 2291-2015 E-mail: crotc@meic.go.cr  
Website: http://www.reglatec.go.cr/  
The full text of the document is available at http://www.reglatec.go.cr/consulta/RTCA_11-
03-64-11_REQUISITOSREGPRODNAT.pdf .