G/TBT/N/PAN/108  
10 February  2020 
(20-1012) 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 : PANAMA  
If applicable, name of local government involved (Articles 3.2 and 7.2):  
2. Agency responsible:  
Ministerio de Comercio e Industrias  (Ministry of Trade and Industry)  
Dirección General de Normas y Tecnología Industrial (Directorate -General for Standards 
and Industrial Technology)  
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:  
Ministerio de Comercio e Industrias  
Dirección General de Normas y Tecnología Industrial  
Vía Ricardo J. A lfaro, Edificio Plaza Edison, 3er Piso  
Panamá, Panamá  
Tel.: (+507) 560 -0716/(+507) 560 -0600, Ext. 5966  
Email: dgnti@mici.gob.pa /uperez@minsa.gob.pa  
Website: www.mici.gob.pa  
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 additi on, where applicable) : 
ICS 11.120.10  
5. Title, number of pages and language(s) of the notified document : Reglamento 
Técnico Centroamericano 11.03.64:19 Productos Farmacéuticos . Productos Naturales 
Medicinales para Uso Humano . Requisitos de Registro Sanitario  (Central American 
Technical Regulation (RTCA) No. 11.03.64:19 : "Pharmaceutical products . Natural 
medicines for human use . Sanitary registration requirements" ) (27 pages, in Spanish)  
6. Description of content : The purpose of the notified  Technical Regulation is to establish 
the conditions and requirements for the sanitary registration of natural medicines for 
human use intended for marketing . The Technical Regulation applies to natural medicines 
for human use that are manufactured or impo rted by natural or legal persons for 
marketing in the Central American region.  
It does not apply to products containing as the constituent responsible for 
pharmacological activity active substances that are chemically synthesized or isolated 
from natural m aterial, or to ophthalmic or parenteral pharmaceutical products.  
7. Objective and rationale, including the nature of urgent problems where 
applicable : Protection of human health  G/TBT/N/PAN/108  
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  8. Relevant documents:  
• RTCA Productos Farmacéuticos . Productos Naturales Medicinales para uso 
Humano . Requisitos de Etiquetado.  (Current version)  
• RTCA Productos Farmacéuticos . Productos Naturales Medicinales para uso 
Humano . Verificación de la Calidad.  (Current version)  
• RTCA Productos Farmacéuticos . Productos Naturales Medicinales Para Uso 
Humano . Buenas Prácticas de Manufactura.  (Current version)  
9. Proposed date of adoption : To be determined  
Proposed date of entry into force : To be determined  
10. Final date for comments : 60 days from 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:  
Ministerio de Comercio e Industrias  
Dirección General de Normas y Tecnología Industrial  
Vía Ricardo J. A lfaro, Calle El Paical, Edificio Plaza Edison, 3er Piso  
Panamá, Panamá  
Tel.: (+507) 560 -0716/(+507) 560 -0600, Ext. 5968/5967  
Email: dgnti@mici.gob.pa ; uperez@minsa.gob.pa  
Website: www.mici.gob.pa  
https://members.wto.org/crnattachments/2020/TBT/PAN/20_0965_00_s.pdf