G/TBT/N/CRI/142  
16 August 2013  
(13-4419)  Page: 1/2  
Committee on Technical Barriers to Trade  Original: Spanish  
 
  NOTIFICATION 
The following notification is being circulated in accordance with Article 10.6. 
 
1. Notifying Member:  COSTA RICA 
If applicable, name of local governme nt involved (Articles 3.2 and 7.2):  
2. Agency responsible:  
Ministerio de Salud de Costa Rica  (Ministry of Health) 
Dirección de Regulación de Productos de Interés Sanitario  (Directorate for the Regulation 
of Products of Sanitary Interest) Unidad de Normalización y Control  (Standardization and Control Unit) 
Tel.: (+506) 2233-6922 
Fax: (+506) 2255-4512 
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 di fferent from above:  
TBT Enquiry Point 
Ministerio de Economía, Industria y Comercio, MEIC  (Ministry of the Economy, Industry 
and Trade) Apartado Postal 10216-1000 Tel.: (+506) 2549-1479 
Fax: (+506) 2291-2015 
E-mail: crotc@meic.go.cr  
Website: http://www.meic.go.cr/reglatec  
3. Notified under Arti cle 2.9.2 [X], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], other:   
4. Products covered (HS or CCCN wher e applicable, otherwise national tariff 
heading. ICS numbers may be provid ed in addition, where applicable):  
International Classification for Standards (ICS) code 11.120.99  
5. Title, number of pages and lang uage(s) of the notified document:  
RTCA 11.03.69:13, Productos Farmacéuticos.  Productos Naturales Medicinales de Uso 
Humano. Buenas Prácticas de Manufactura (Central American Technical Regulation 
(RTCA) No. 11.03.69:13: Pharmaceutical products. Natural medicines for human use. 
Good Manufacturing Practices) (51 pages, in Spanish).  
6. Description of content:  The notified Technical Regulation establishes the principles 
and guidelines set forth in the Good Manufacturing Practices that regulate all procedures 
involved in the manufacture of natural medicines for human use, in order to assure the efficacy, safety and quality of such products. 
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health. G/TBT/N/CRI/142 
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  8. Relevant documents:  
- Proyecto de RTCA Reglamento Técnico Centroamericano de Productos Farmacéuticos. 
Medicamentos de Uso Humano. Buenas Prácticas de Manufactura para la Industria 
Farmacéutica  (Draft Central American Technical Regulation on pharmaceutical 
products. Medicines for human use. Good manufacturing practices for the pharmaceutical industry). 
- WHO guidelines on good manufacturing practices (GMP) for herbal medicines, 2007. 
9. Proposed date of adoption: 
Proposed date of entry into force:   To be determined. 
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 addresse s, if available, of other body: 
Centro de Información de Obst áculos Técnicos al Comercio 
Ministerio de Economía, Industria y Comercio - MEIC 
Apartado Postal 10216-1000 
Tel.: (+506) 2549-1479 Fax: (+506) 2291-2015 
E-mail: crotc@meic.go.cr  
Website: http://www.meic.go.cr/reglatec  
Text available at: 
http://www.meic.go.cr/reglatec/co nsulta/productos_farma.pdf 
http://members.wto.org/crnattachments/2013/tbt/CRI/13_3275_00_s.pdf