WORLD TRADE  
ORGANIZATION   
G/TBT/N/CRI/117 
9 June 2011 
 (11-2849) 
Committee on Technical Barriers to Trade Original:   Spanish 
  
 
NOTIFICATION 
 
The following notification is being circ ulated 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, Departamento de 
Reglamentación Técnica  (Ministry of the Economy, Industry and Trade, Technical 
Regulation Department) Tel.: +(506) 2291-1936 or 2291-2115, Ext. 206 
Fax: +(506) 2291-2007 
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, MEIC 
Apartado Postal 10216-1000, San José 
Tel.:  +(506) 2291-1936 or 2291-2115, Ext. 206 Fax:  +(506) 2291-2015 E-mail:  crotc@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 11.120.99 
5. Title, number of pages and language(s) of the notified document:   Reglamento de 
Buenas Prácticas de Almace namiento, Acondicionamiento Secundario y Distribución de 
Medicamentos en Droguerías  (Regulation on Good Practices for the storage, secondary 
packaging and distribution of medicines by pharmaceutical establishments) (38 pages, in 
Spanish) 
6. Description of content:   The notified Regulation applies to all pharmaceutical 
establishments, including those authorized to perform secondary packaging, in particular 
the re-labelling of finished products and the secondary packaging of primary-packaged 
products, subject to authorization by th e proprietary laboratory or manufacturer. 
7. Objective and rationale, including the nature of urgent problems where applicable:  
Protection of human life and health G/TBT/N/CRI/117 
Page 2  
 
  8. Relevant documents:  
Decreto Ejecutivo  (Executive Decree) No. 28466-S of the Ministry of Health, " Reglamento 
de inscripción, control, importación y publicid ad de medicamentos y sus actualizaciones " 
(Regulation on the registration, control, im portation and advertising of medicines and 
updates thereto), published in Official Journal La Gaceta  No. 42 of 29 February 2000; 
Executive Decree No. 34728-S of the Ministry of Health, " Reglamento general para el 
otorgamiento de permisos de func ionamiento del Ministerio de Salud"  (General 
Regulations governing the issuing of operati ng permits by the Ministry of Health), 
published in Official Journal No. 174 of 9 September 2008; 
Executive Decree No. 29444-S of the Ministry of Health, " Reglamento de control estatal de 
medicamentos " (Regulation on the State control of medicines), published in Official 
Journal No. 88 of 9 May 2001; 
Executive Decree No. 35994-S of the Ministry of Health, " Reglamento técnico sobre 
buenas prácticas de manufactura  para la industria farmacéutica, productos farmacéuticos 
y medicamentos de uso humano " (Technical Regulation on Good Manufacturing Practices 
(GMPs) for the pharmaceutical industry, phar maceutical products and medicines for human 
use), published in Official Journal No. 91 of 12 May 2010; 
Executive Decree No. 36039-S of the Ministry of Health, " Reglamento para la disposición 
final de medicamentos, materias primas y sus residuos " (Regulation on the final disposal of 
medicines, raw materials and their waste), published in Official Journal No. 122 of 
24 June 2010; 
Executive Decree No. 27000-MINAE of the Ministry of the Environment and Energy, 
"Reglamento sobre las características y el  listado de los residuos peligrosos industrials " 
(Regulation establishing the characteristics of and a list of hazardous industrial wastes), 
published in Official Journa l No. 124 of 29 June 1998; 
Executive Decree No. 27001-MINAE of the Ministry of the Environment and Energy, 
"Reglamento para el manejo de los residuos peligrosos industrials " (Regulation on 
hazardous industrial waste management), pub lished in Official Journal No. 101 of 
27 May 1998; 
Decreto  (Decree) No. 28930-S of the Ministry of Health, " Reglamento para el manejo de 
productos peligrosos " (Regulation on hazardous produc t management), published in 
Official Journal No. 184 of 26 September 2000; 
Decree No. 36093-S of the Ministry of Health, " Reglamento sobre el manejo de residuos 
sólidos ordinaries " (Regulation on common solid waste management), published in Official 
Journal No. 158 of 16 August 2010; 
Decree No. 1, " Reglamento general de se guridad e higiene de trabajo " (General 
Regulations on workplace safety and hygiene), published in Official Journal No. 19 of 
24 January 1967. 
9. Proposed date of adoption: 
 
Proposed date of entry into force:  Date of publication in the Official Journal 
La Gaceta 
Six months' validity following publication in the 
Official Journal 
10. Final date for comments:   60 days as from the date of notification  G/TBT/N/CRI/117 
 Page 3 
 
 
  11. Texts available from:  National enquiry  point [X] or address, telephone and fax 
numbers, e-mail and website addresses, if available, of the other body: 
TBT Enquiry Point 
San José, Costa Rica Website: http://www.reglatec.go.cr/  
E-mail: crotc@meic.go.cr  
Tel.: +(506) 2291-1936 or 2291-2115, Ext. 206 
Fax: +(506) 2291-2015 
 The full text of the document is available at: http://www.reglatec.go.cr/consulta/RTCR-453-2011BPM-OMC-2011.pdf  and 
http://members.wto.org/crnattach ments/2011/tbt/CRI/11_1793_00_s.pdf