. /.  WORLD TRADE  
ORGANIZATION   
G/TBT/N/GTM/72 
17 June 2011 
 (11-3015) 
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:   GUATEMALA 
If applicable, name of local government involved (Articles 3.2 and 7.2):    
2. Agency responsible:  
Ministerio de Economía  (Ministry of the Economy) 
Dirección de Política Comercial Externa  (Directorate of Foreign Trade Policy) 
Coordinación Inte gración Económica  (Economic Integration Coordination Office) 
Tel.: +(502) 2412-0339, Ext. 4310 
E-mail: rclaveria@mineco.gob.gt  
Website: http://www.mineco.gob.gt/  
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:  
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):  ICS code 11.120.01 
5. Title, number of pages and language(s) of the notified document:   RTCA 11.03.59:11 
Productos Farmacéuticos.  Medicamentos de  uso humano.  Requisitos de Registro 
Sanitario  (Central American Technical Regulation (RTCA) No. 11.03.59:11:  
Pharmaceutical products.  Medicines for human use.  Sanitary registration requirements) 
(26 pages, in Spanish) 
Link: 
http://www.mineco.gob.gt/Presentacion/Explor arDirectorio.aspx?titulo=TituloIntegracionE
conomica&subtitulo=Sistema+de+Integraci %u00f3n+Centroameri cana&llaveExploracion=
Integraci%u00f3n+Centroamericana " 
6. Description of content:   The notified Technical Regulation seeks to establish the 
conditions and requirements for the sanitary regi stration of medicines for human use.  It 
applies to medicines for human use that are ma nufactured or imported by natural or legal 
persons for marketing in the Central Ameri can region.  The Regulation does not cover 
magistral preparations.  Biological and biotechnological medicines shall be registered in 
accordance with the domestic legislation of each  State Party.  Where a State Party does not 
have domestic legislation on the registration of  biological and biotechnological medicines, 
the notified Regulation shall be applied to these products. G/TBT/N/GTM/72 
Page 2  
 
  7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human health. 
8. Relevant documents:  
(a) Central American Technical Regulation (RTCA) No. 11.03.39:06:  Productos 
Farmacéuticos.  Reglamento de Vali dación de Métodos Analíticos para la 
Evaluación de la Calidad de los Medicamentos (Pharmaceutical products.  
Regulations on the validation of analytical methods for assessing the quality of medicines). 
(b) RTCA No. 11.01.02:04:  Productos Farmacéuticos.  Etiquetado de Productos 
Farmacéuticos para Uso Humano  (Pharmaceutical products.  Labelling of 
pharmaceutical products for human use). 
(c) RTCA No. 11.01.04:05:  Productos Farmacéuticos.  Estudios de Estabilidad de 
Medicamentos para Uso Humano  (Pharmaceutical products.  Stability studies on 
medicines for human use). 
(d) RTCA No. 11.03.47:07:  Productos Farmacéuticos.  Medicamentos para Uso 
Humano.  Verificación de la Calidad  (Pharmaceutical products.  Medicines for 
human use.  Quality verification). 
(e) RTCA Buenas Prácticas de Manufactura  de la Industria Farmacéutica (Good 
manufacturing practices for the pharmaceutical industry) (COMIECO Resolution No. 93-2002, Annex 3). 
(f) RTCA No. 11.03.42:07:  Productos Farmacéuticos.  Medicamentos de Uso 
Humano.  Buenas Prácticas de Manufac tura para la Industria Farmacéutica  
(Pharmaceutical products.  Medicines for human use.  Good manufacturing practices 
for the pharmaceutical industry). 
9. Proposed date of adoption: 
Proposed date of entry into force:   Date of publication in the Official Journal 
To be determined 
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, e-mail and website addresses,  if available of the other body: 
Ministerio de Salud Pública y Asistencia Social 
3ª Calle final 2-10 Col.  Valles de Vista Hermosa Zona 15 Ciudad de Guatemala Website: http://www.mspas.gob.gt/  
Contact person:  Ms Ana Beatriz Cordero 
Tel.: +(502) 2365-6255 to 60 
E-mail: abcormo@yahoo.es  
Ministerio de Economía 
8ª Ave. 10-43 Zona 1 Ciudad de Guatemala Tel.: +(502) 2412-0339, Ext. 4310 
E-mail: rclaveria@mineco.gob.gt  
Website: http://www.mineco.gob.gt/