G/TBT/N/GTM/91  
11 August 2016  
(16-4327) 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 government involved (Articles 3.2 and 7.2):  
2. Agency responsible : Ministerio de Salud Pública y Asis tencia Social  (Ministry of Public 
Health and Social Welfare)  
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 indicate d if different from above:  
Departamento de Regulación y Control de Productos Farmacéuticos y Afines de la Dirección 
General de Regulación, Vigilancia y Control de la Salud del Ministerio de Salud Pública y 
Asistencia Social  (Department for the Regulation a nd Control of Pharmaceutical and 
Related Products, Directorate -General of Health Regulation, Surveillance and Control, 
Ministry of Public Health and Social Welfare)  
3era. Calle final 2 -10 
Colonia Valles de Vista Hermosa  
Zona 15, Ciudad de Guatemala  
Contact  person : Raúl Mendoza Paredes  
Tel.: (+502) 2502 -2503, Ext.  109 
Email: vigilancia@medicamentos.com.gt /rmendozap61@gmail.com   
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) : 
Pharmaceutical and related products.  
5. Title, number of pages an d language(s) of the notified document : Reglamento para 
el Control de Productos Farmacéuticos y Afines  (Regulation governing the control of 
pharmaceutical and related products) (50 pages, in Spanish)  
6. Description of content : Revision of the Regulation o f the Department of Pharmaceutical 
and Related Products, Government Decision 712 -99. The Regulation will be applied by the 
Department for the Regulation and Control of Pharmaceutical and Related Products of the 
Directorate -General of Health Regulation, Sur veillance and Control at the Ministry of Public 
Health and Social Welfare.  
7. Objective and rationale, including the nature of urgent problems where 
applicable : Revision of the Regulation of the Department of Pharmaceutical and Related 
Products, Governmen t Decision 712 -99. 
8. Relevant documents : Central American Technical Regulations relating to medicines and 
pharmaceutical and related products:  
 11.01.02:04 Product labelling  
 11.03.42:07 Good manufacturing practices for the pharmaceutical industry  G/TBT/N/GTM/91  
- 2 - 
   11.03.39 :06 Validation of analytical methods for assessing medicines  
 71.03.49:08 Good manufacturing practices for cosmetic products  
 11.01.04:10 Stability studies of medicines  
 71.01.36:06 Labelling of cosmetic products  
 71.03.45:07 Verification of cosmetic product q uality  
 71.03.45:06 Sanitary registration of cosmetic products  
 71.03.37:07 Registration of cleaning products  
 71.03.38:01 Labelling of cleaning products  
 65.03.44:07 Registration of pesticides  
 11.03.56:01 Natural medicines for human use  
 11.03.64:11 Registrati on of natural products for human use  
 11.03.59:11 Requirements governing the sanitary registration of natural products 
for human use  
9. Proposed date of adoption : To be determined.  
Proposed date of entry into force : To be determined.  
10. Final date for co mments : 60 days from the date of circulation of the notification.  
11. Texts available from : National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:  
Departamento de Regulación y Control  de Productos Farmacéuticos y Afines de la Dirección 
General de Regulación, Vigilancia y Control de la Salud del Ministerio de Salud Pública y 
Asistencia Social  
3era. Calle final 2 -10 
Colonia Valles de Vista Hermosa  
Zona 15, Ciudad de Guatemala  
Contact per son: Raúl Mendoza Paredes  
Tel.: (+502) 2502 -2503, Ext. : 109 
Email: vigilancia@medicamentos.com.gt /rmendozap61@gmail.com