G/TBT/N/CRI/171  
6 December  2017 
(17-6709) 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 Asuntos Jurídicos  (Directorate of Legal Affairs)  
Tel.: (+506) 2233 -0464 
Fax: (+506) 2291 -2015 
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 Comercio , MEIC (Ministry of the Economy, Industry 
and Trade)  
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 [ ], 2.10.1 [ ], 5.6.2 [X], 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) : 11.120.10  
5. Title, number of pages and language(s) of the notified document : Procedimiento 
para la verificación del cumplimiento de las buenas prácticas de manufactura de 
medicamentos para uso humano (Procedure for the verification of compliance with good 
manufacturing practices for m edicines for human use) (25 pages, in Spanish)  
6. Description of content : The notified text establishes the regulations governing the 
process to verify compliance with good manufacturing practices for medicines, with the aim 
of ensuring the quality of medicines, as one of the factors for the reduction of risks 
associated with manufacturing . It applies to manufacturing plants belonging to national or 
foreign laboratories that manufacture or market pharmaceutical products in the national 
territory, to ens ure the quality of medicines.  
7. Objective and rationale, including the nature of urgent problems where 
applicable : Protection of human health.  G/TBT/N/CRI/171  
- 2 - 
  8. Relevant documents:  
 Decreto Ejecutivo N° 38732 -S-COMEX -MEIC del 02 de julio de 2014, que Publica 
Resolución  N° 339 -2014 (COMIECO -LXVII) del 25 de abril del 2014 y sus Anexos 
(Executive Decree No. 38732 -S-COMEX -MEIC of 2 July 2 014 publishing Resolution 
No. 339-2014 (COMIECO -LXVII) of 2 5 April 2 014 and the annexes thereto)  
 Reglamento Técnico Centroamericano RTCA  11.03.42:07 Productos Farmacéuticos . 
Medicamentos Para Uso Humano . Buenas Prácticas de Manufactura para la 
Industria Farmacéutica (Central American Technical Regulation (RTCA) No. 
11.03.42:07 : Pharmaceutical products . Medicines for human use . Good 
manufac turing practices for the pharmaceutical industry)  
 Decreto Ejecutivo N° 38414 -COMEX -MEIC-S del 28 de febrero de 2014, que 
Pública Resolución Nº 333 -2013 (COMIECO - LXVI) de fecha 12 de diciembre del 
2013 (Executive Decree No. 38414 -COMEX -MEIC-S of 2 8 February 2 014 publishing 
Resolution No. 333-2013 (COMIECO - LXVI) of 1 2 December 2 013) 
 Reglamento Técnico Centroamericano RTCA 11.03.59:11 Productos Farmacéuticos . 
Medicamentos para uso humano . Requisitos de registro sanitario  (Central American 
Technical Re gulation (RTCA) No. 11.03.59:11 Pharmaceutical products . Medicines 
for human use . Sanitary registration requirements)  
9. Proposed date of adoption : Upon publication in Official Journal La Gaceta.  
Proposed date of entry into force : Six months after publica tion in the Official Journal La 
Gaceta . 
10. Final date for comments : 60 days from the date of notification.  
11. Texts available from : National enquiry point [X] 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  
Email: crotc@meic.go.cr  
San José, Costa Rica  
Apartado Postal 10216 -1000 
Tel.: +(506) 2549 -1479 
Fax: +(506) 2291 -2015 
Full text available online at:  
http://www.reglatec.go.cr/reglatec/principal.jsp  
https://members. wto.org/crnattachments/2017/TBT/CRI/17_5423_00_s.PDF