  
  
G/TBT/N/HND/73/Add.2  
23 April 2020 
(20-3213) Page: 1/1 
Committee on Technical Barriers to Trade  Original:  Spanish  
 
 NOTIFICATION  
Addendum  
The following communication, dated 2 7 March 2 020, is being circulated at the request of the 
delegation of Honduras . 
 
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Central American Technical Regulation (RTCA) No. 11.03.64:11 : "Pharmaceutical products . Natural 
medicines for human use . Sanitary registration requirements"  
On 3 0 January 2 020, the Government of the Republic of Honduras notified, in document 
G/TBT/N/HND/73/Add.1, Central American Technical Regulation (RTCA) No. 11.03. 64:11 : 
"Pharmaceutical products . Natural medicines for human use . Sanitary registration requirements" . 
The purpose of this Technical Regulation is to establish conditions and requirements for the 
sanitary registration of natural medicines for human use int ended for marketing . It applies to 
natural medicines for human use that are manufactured or imported by natural or legal persons for 
marketing in the Central American region.  
This Technical Regulation  does not apply to products containing, as the constitue nt responsible for 
pharmacological activity, active substances that are chemically synthesized or isolated from 
natural material, or to ophthalmic or parenteral pharmaceutical products.  
Furthermore, WTO Members are advised that the deadline for submitting comments or 
observations has been extended until 2 8 April 2 020. 
The relevant text is available from:  
Secretaría de Desarrollo Económico  
Dirección General de Integración Económica y Política Comercial  
Boulevard José Cecilio del Valle  
Edificio San José, 3er piso 
Fax: (+504) 2235 -8383 / 2235 -5047 
Email: gsalinas_sic@yahoo.com  
Website: https://sde.gob.hn/wp -content/uploads/2020/01/RTCA -Registro -Naturales -Medicinales -
versi%C3%B3n -CPI.pdf  
Agencia de Regulación Sanitaria (ARSA)  
Dirección de Productos Farmacéuticos y otros Productos de Interés Sanitario  
Calle Los Alcaldes, Frente al City Mall  
Email: consultapublica@arsa.gob.hn  
Website: http:// www.arsa.gob.hn  
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