. /.  WORLD TRADE  
ORGANIZATION   
G/TBT/N/CRI/119 
13 July 2011 
 (11-3467) 
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:  
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 
Ministerio de Economía, Industria y Comercio , MEIC 
(Ministry of the Economy, Industry and Trade) 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 11.120.01 
5. Title, number of pages and language(s) of the notified document:   RTCA 11.03.59:11, 
Productos Farmacéuticos.  Medicamentos de  Uso Humano.  Requisitos de Registro 
Sanitario  (Central American Technical Regulation (RTCA) No. 11.03.59:11:  
Pharmaceutical products.  Medicines for human use.  Sanitary registration requirements) 
(26 pages, in Spanish) 
6. Description of content:   The notified Technical Regulation establishes the conditions and 
requirements for the sanitary registration of medicines for human use.  It applies to 
medicines for human use that are manufactured or imported by natural or legal persons for 
marketing in the Central American region.   The Regulation does not cover magistral 
preparations.  Biological and biotechnological medicines shall be registered in accordance 
with the domestic legislation of each State Party.  Where a State Party does not have 
domestic legislation on the registration of biological and biotechnological medicines, the notified Regulation shall be  applied to these products. 
7. Objective and rationale, including the nature of urgent problems where applicable:  
Protection of human health G/TBT/N/CRI/119 
Page 2  
 
  8. Relevant documents:  
(a)  Central American Technical Regulation (RTCA) No. 11.03.39:06:  Productos 
Farmacéuticos.  Reglamento de Validación de Métodos Analíticos para la Evaluación 
de la Calidad de los Medicamentos  (Pharmaceutical products.  Regulations on the 
validation of analytical methods for assessing the quality of medicines); 
(b)  RTCA No. 11.01.02:04:  Productos Farmacéuticos.  Etiquetado de Productos 
Farmacéuticos para Uso Humano  (Pharmaceutical products.  Labelling of 
pharmaceutical products for human use); 
(c)  RTCA No. 11.01.04:05:  Productos Farmacéuticos.  Estudios de Estabilidad de 
Medicamentos para Uso Humano  (Pharmaceutical products.  Stability studies on 
medicines for human use); 
(d)  RTCA No. 11.03.47:07:  Productos Farmacéuticos.  Medicamentos para Uso 
Humano.  Verificación de la Calidad  (Pharmaceutical products.  Medicines for human 
use.  Quality verification); 
(e)  RTCA, Buenas  Prácticas de Manufactura de  la Industria Farmacéutica  (Good 
manufacturing practices for the pharmaceu tical industry) (COMIECO Resolution 
No. 93-2002, Annex 3); 
(f)  RTCA No. 11.03.42:07:  Productos Farmacéuticos.  Medi camentos de Uso Humano. 
Buenas Prácticas de Manufactur a para la Industria Farmacéutica  (Pharmaceutical 
products.  Medicines for human use.  Good manufacturing practices for the pharmaceutical industry).
  
9. Proposed date of adoption: 
 
Proposed date of entry into force:  Date of publication in the Official Journal 
La Gaceta 
Six months' validity following publication in the 
Official Journal 
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 
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/reg-medic-uso-humano.pdf  and 
http://members.wto.org/crnattach ments/2011/tbt/CRI/11_2189_00_s.pdf