G/TBT/N/CRI/197  
8 July 2022 
(22-5259) 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 Salud  (Ministry of Health)  
Dirección de Regulación de Productos de Interés Sanitario  (Directorate for Regulation of 
Products of Sanitary Interest)  
Tel.: (+506) 2233 -6922 
Name and address (including telephone and fax numbers, email and website  
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:  
Información de Obstáculos Técnicos al Comercio  (TBT Enquiry Point)  
Ministerio de Economía, Industria y Com ercio, MEIC (Ministry of the Economy, Industry 
and Trade)  
Tel.: (+506) 2549 -1479 
Email: crotc@meic.go.cr ; msolera@meic.go.cr  
Website : http://www.reglatec.go.cr  
3. Notified under Article 2.9.2 [ ], 2.10.1 [ ], 5.6.2 [X], 5.7.1 [ ], 3.2 [ ], 7.2 [ ], 
other:  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading . ICS numbers may be provided in addition, where applicable) : 
Pharmaceutics in general (ICS code : 11.120.01)  
5. Title, number of pages and language(s) of the notified document : Requisitos y 
procedimiento para la homologación o reconocimiento del registro sanitario de 
medicamentos otorgad os por las autoridades reguladoras miembros del Consejo 
Internacional de Armonización de Requisitos Técnicos para Productos Farmacéuticos de 
Uso Humano (ICH)  (Requirements and procedure for the approval or recognition of the 
sanitary registration of medicines granted by regulatory authorities that are members of 
the International Council for Harmonisation of Technical Requirements for 
Pharmaceuticals for Human  Use (ICH)) (12 pages, in Spanish)  
6. Description of content : Approval or recognition of the sanitary registration of medicines 
granted by any of the regulatory authorities that are members of the International Council 
for Harmonisation of Technical Requi rements for Pharmaceuticals for Human Use (ICH) . 
The approval or recognition is unilateral and at the discretion of the Ministry of Health 
authorities, and applies to medicines with sanitary registration granted by regulatory 
authorities that are members o f the ICH.  
7. Objective and rationale, including the nature of urgent problems where 
applicable : Protection of human life and health.  G/TBT/N/CRI/197  
- 2 - 
  8. Relevant documents : - 
9. Proposed date of adoption : 30 June 2 022 
Proposed date of entry into force : Six months after publication in Official Journal La 
Gaceta.  
10. Final date for comments : Not applicable  
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  
Tel.: (+506) 2549 -1479 
http://www.reglatec.go.cr/reglatec/principal.jsp  
https://members.wto.org/crnattachments/2022/TBT/CRI/22_4568_00_s.pdf