  
  
G/TBT/N/CRI/185  
29 August  2019 
(19-5565) 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 government involved (Articles 3.2 and 7.2):  
2. Agency responsible:  
Ministerio de Economía, Industria y Comercio  (Ministry of the Economy, Industry and 
Trade)  
Tel.: (+506) 2549 -1479 
Name and address (including telephone and fax numbers, email and website 
addresses, if available) of agency or authority designated to handle comments 
regar ding the notification shall be indicated if different from above:  
Información de Obstáculos Técnicos al Comercio  (TBT Enquiry Point)  
Ministerio de Economía, Industria y Comercio, MEIC  
Apartado Postal 10216 -1000 
Tel.: (+506) 2549 -1479 
Fax: (+506) 2291 -2015 
Email: 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 CC CN where applicable, otherwise national tariff 
heading . ICS numbers may be provided in addition, where applicable) : 
ICS 11.120.10  
5. Title, number of pages and language(s) of the notified document : RTCR 496: 
2018. Productos farmacéuticos . Medicamentos de uso humano . Presencia de gluten en 
medicamentos  (Costa Rican Technical Regulation (RTCR) No. 496: 2018, Pharmaceutical 
products . Medicaments for human use . Presence of gluten in medicaments) (6 pages, in 
Spanish)  
6. Description of content : The purpose of the notified regulation is to set the amount of 
gluten beyond which a label will be required with the legend set forth in 
RTCA  No. 11.01.02:04, Pharmaceutical products . Labelling of pharmaceutical products 
for human use.  
7. Objecti ve and rationale, including the nature of urgent problems where 
applicable : Protection of human life.  
8. Relevant documents:  
N/A G/TBT/N/CRI/185  
- 2 - 
  9. Proposed date of adoption : Upon publication in Official Journal La Gaceta.  
Proposed date of entry into force : Three months after publication in the Official Journal 
La Gaceta . 
10. Final date for comments : 60 days from notification  
11. Texts available from : National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:  
Centro de Obstáculos Técnicos al Comercio  (TBT Centre)  
Website: http://www.reglatec.go.cr  
WTO Contact Point: crotc@meic.go.cr /msolera@meic.go.cr  
San José, Costa Rica  
Apartado Postal 10216 -1000 
Tel.: (+506) 2549 -1479 
Fax: (+506) 2291 -2015 
Full text available at:  
http://www.reglatec.go.cr/reglatec/principal.jsp  
https://members.wto.org/crnattach ments/2019/TBT/CRI/19_4758_00_s.pdf  
 