. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/CRI/84 
15 December 2008 
 (08-6143) 
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 Fax: +(506) 2297-1439 
Name and address (including telephone and fax numbers, e-mail and web site 
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 Web site: 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):  65.020.30 
5. Title, number of pages and language(s) of the notified document:   RTCA 65.05.51:08: 
Medicamentos Veterinarios y Productos Afines, Establecimientos que los Fabrican, Comercializan, Fraccionan o Almacenan. Requisitos de Registro Sanitario y Control  
(Central American Technical Regulation (RTCA) No. 65.05.51:08:  Veterinary drugs and related products, and esta blishments engaged in the manufact ure, marketing, fractioning or 
storage thereof.  Sanitary registration and c ontrol requirements) (37 pages, in Spanish). 
6. Description of content:   The aim of the notified Regulation is to establish provisions 
governing the sanitary registration and control of  veterinary drugs a nd related products and 
establishments in this sector.  This Regulation applies to all veterinary drugs and related 
products marketed in Central American countries. G/TBT/N/CRI/84 
Page 2  
 
  7. Objective and rationale, including the na ture of urgent problems where applicable:
 
 Protection of human and animal health and the environment. 
8. Relevant documents:  
- Code of Federal Regulations  (CFR) of the Food and Drug Administration (FDA), 
Titles 9 and 21, United States of America; 
- International Programme on Chemical Safety  (IPCS), World Health 
Organization (WHO); 
- Codex Alimentarius Commission: Maximu m Residue Limits (MRLs) approved for 
veterinary drugs and pesticides; 
- European Medicines Agency (EMEA): Maxi mum Residue Limits (MRLs) approved for 
veterinary drugs and pesticides; 
- United States Pharmacopoeia ; 
- European Pharmacopoeia . 
9. Proposed date of adoption: 
 
Proposed date of entry into force:  } Upon publication in the Diario Oficial 
(Official Journal). 
To be determined 
10. Final date for comments:   60 days as from the date of this notification 
11. Texts available from:  National enquiry point [  X ] or address, telephone and fax 
numbers, e-mail and web site addresses, if available of the other body: 
TBT Enquiry Point 
San José, Costa Rica 
E-mail: crotc@meic.go.cr  
Web site: http://www.reglatec.go.cr  
Tel.: +(506) 2235-2700, ext. 221 Fax: +(506) 2297-1439 or 2236-7192 
The full text of the draft regulation is available online at: 
http://www.reglatec.go.cr/consulta/RTCA% 20medicamentos%20para %20animales%20para
%20notificar%20a%20OMC%20oct%2008.pdf  
http://members.wto.org/crnatt achments/2008/tbt/cri/08_3925_00_s.pdf