G/TBT/N/GTM/83  
9 August 2013  
(13-4271)  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:  GUATEMALA 
If applicable, name of local governme nt involved (Articles 3.2 and 7.2):   
2. Agency responsible:  
Ministerio de Salud Pública y Asistencia Social  (Ministry of Public Health 
and Social Welfare) Dirección General de Regulación, Vigilancia y Control de la Salud  (Directorate-General 
of Health Regulation, Surveillance and Control) 
Departamento de Regulación y Control de Productos Farmacéuticos y Afines  
(Department for the Regulation and Control of Pharmaceutical and Related Products) Tel.: (+502) 2365-6252 or 2365-6255 
E-mail: drcpfa.jefatura@gmail.com  
Name and address (including telephone and fax numbers and e-mail 
and website addresses, if available) of  agency or authority designated to handle 
comments regarding the notification shall be indicated if di fferent from above:  
Ministerio de Economía  (Ministry of the Economy) 
Departamento de Integración Económica  (Economic Integration Department) 
Apartado Postal 01001 
Tel.: (+502) 2412-0200, Ext. 4301 
Fax: (+502) 2412-0339 E-mail: rclaveria@mineco.gob.gt   
Website: http://www.mineco.gob.gt/Presen tacion/ComercioExterior.aspx  
3. Notified under Arti cle 2.9.2 [X], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], other:   
4. Products covered (HS or CCCN wher e applicable, otherwise national tariff 
heading. ICS numbers may be provid ed in addition, where applicable):  
International Classification for Standards (ICS) code 11.120.99 
5. Title, number of pages and lang uage(s) of the notified document:  RTCA 
11.03.69:13, Productos Farmacéuticos. Productos Naturales Medicinales de Uso Humano. Buenas Prácticas de Manufactura (Central American Technical Regulation (RTCA) 
No. 11.03.69:13: Pharmaceutical products. Natural medicines for human use. 
Good Manufacturing Practices) (51 pages, in Spanish). 
6. Description of content:  The notified Technical Regulation establishes the principles 
and guidelines set forth in the Good Manufacturing Practices that regulate all procedures involved in the manufacture of natural medicines for human use, in order to assure 
the efficacy, safety and quality of such products. 
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health. G/TBT/N/GTM/83 
- 2 - 
  8. Relevant documents:  
- Proyecto de RTCA Reglamento Técnico Centroamericano de Productos 
Farmacéuticos Medicamentos de Uso Humano. Buenas Prácticas de Manufactura 
para la Industria Farmacéutica  (Draft Central American Technical Regulation 
on pharmaceutical products. Medicines for human use. Good manufacturing practices for the pharmaceutical industry). 
- WHO guidelines on good manufacturing practices (GMP) for herbal medicines, 2007. 
9. Proposed date of adoption: 
Proposed date of entry into force:   To be determined. To be determined. 
10. Final date for comments:  60 days as from the date of notification. 
11. Texts available from: National enquiry point [X] or address, telephone and fax 
numbers and e-mail and website addresse s, if available, of other body: 
Ministerio de Economía, MINECO 
Departamento de Integración Económica 
Apartado Postal 01001 
Tel.: (+502) 2412-0200, Ext. 4310 Fax: (+502) 2412-0339 
E-mail: rclaveria@mineco.gob.gt   
Website: http://www.mineco.gob.gt   
Full text available at: 
http://www.mineco.gob.gt/Presen tacion/ExplorarDirectorio.as px?titulo=TituloIntegracion
Economica&subtitulo=Sistema+de+Integraci%u00f3n+Centroamericana&llaveExploracion
=Integraci%u00f3n+Centroamericana&Resoluciones+COMIECO