WORLD TRADE
G/TBT/N/CRI/84
15 December 2008
ORGANIZATION
(08-6143)
Committee on Technical Barriers to Trade
Original: Spanish
NOTIFICATION
The following notification is being circulated 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 establishments engaged in the manufacture, marketing, fractioning or
storage thereof. Sanitary registration and control 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 and 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 nature of urgent problems where applicable:
Protection of human and animal health and the environment.
8.
9.
Relevant documents:
-
Code of Federal Regulations (CFR) of the Food and Drug Administration (FDA),
Titles 9 and 21, United States of America;
-
International Programme
Organization (WHO);
-
Codex Alimentarius Commission: Maximum Residue Limits (MRLs) approved for
veterinary drugs and pesticides;
-
European Medicines Agency (EMEA): Maximum Residue Limits (MRLs) approved for
veterinary drugs and pesticides;
-
United States Pharmacopoeia;
-
European Pharmacopoeia.
Proposed date of adoption:
on
Chemical

Proposed date of entry into force:
Safety
(IPCS),
World
Health
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/crnattachments/2008/tbt/cri/08_3925_00_s.pdf