. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/CRI/101 
21 July 2010 
 (10-3952) 
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, Dirección de Mejora 
Regulatoria y Reglamentación Técnica  (Ministry of the Economy, Industry and Trade, 
Regulatory Improvement and Technical Regulation Directorate) 
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 
Apartado Postal 10216-1000, San José Tel.: +(506) 2235-2700, Ext. 264 Fax: +(506) 2297-1439 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:   Reformas al 
Reglamento de Inscripción, Control, Im portación y Publicidad de Medicamentos 
(Amendments to the Regulations on the registra tion, control, importati on and advertising of 
medicines) (22 pages, in Spanish). 
6. Description of content:   Amendment to Articles 3, 23, 24, 27, 29, 30, 34, 35, 37, 45 and 
50, addition of a new Chapter XI, and abr ogation of Article 32 of Executive Decree 
No. 28466-S of 8 February 2000 "R egulations on the registrati on, control, importation and 
advertising of medicines". 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human health and prevention of practices likely to mislead or deceive 
consumers.  G/TBT/N/CRI/101 
Page 2  
 
  8. Relevant documents:  Executive Decree ( Decreto Ejecutivo ) No. 28466-S "Regulations on 
the registration, control, importation and adve rtising of medicines" of 8 February 2000, 
published in Official Journal La Gaceta de Costa Rica No. 42 of 29 February 2000, 
amended pursuant to Executive Decree No . 34925 of 9 December 2008, published in 
Official Journal No. 238 of 9 December 2008. 
9. Proposed date of adoption: 
Proposed date of entry into force:  Upon publication in the Official Journal 
La Gaceta de Costa Rica 
Six months after 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 other body: 
TBT Enquiry Point 
Ministerio de Economía, Industria y Comercio (MEIC) 
Apartado Postal. 10216-1000 San José, Costa Rica Tel.: (+506) 2235-2700, Ext. 264 Fax: (+506) 2297-1439 
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/medicamentos-13-07-2010.pdf  
and: 
http://members.wto.org/crnatt achments/2010/tbt/cri/10_2830_00_s.pdf