G/TBT/N/PAN/100  
15 August  2018 
(18-5181) 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 : Dirección General de Normas y Tecnología Industrial (Directorate -
General for Standards and Industrial Technology)  
Ministerio de Comercio e Industrias (Ministry of Trade and Industry) Avenida Ricardo 
J. Alfaro, y calle El Paical, Edificio Plaza Edison, 3er Piso, Panamá . Tel.: (+507) 560 -0716, 
Ext. 5968/5964/5786  
Email: dgnti@mici.gob.pa ; uperez@minsa.gob.pa ; edcastillo@minsa.gob.pa  
Website : http://www.mici.gob.pa/  
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 b e 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) : 11.120.01  
5. Title, number of pages and language(s) of the notified document : Reglamento 
Técnico Centroamericano (RTCA) 11.03.59:18, 1era Revisión - Productos Farmacéuticos, 
Medicamentos para Uso Humano . Requisitos de Registro Sanitario  (Cent ral American 
Technical Regulation (RTCA) No. 11.03.59:18, First revision - Pharmaceutical products . 
Medicines for human use . Sanitary registration requirements) (31 pages, in Spanish)  
6. Description of content : The notified Central American Technical Reg ulation (RTCA) 
establishes the conditions and requirements for the sanitary registration of medicines for 
human use . It applies to medicines for human use that are manufactured or imported by 
natural and legal persons for marketing in the territory of the States Parties.  
7. Objective and rationale, including the nature of urgent problems where 
applicable : Protection of human life and health, and prevention of practices likely to 
mislead or deceive consumers.  
8. Relevant documents:  
 Central American Technical Regulation RTCA Productos Farmacéuticos . Reglamento 
De Validación De Métodos Analíticos Para La Evaluación De La Calidad De Los 
Medicamentos  (current version);  
 Central American Technical Regulation RTCA Productos Farmacéuticos . Etiquetado 
De Prod uctos Farmacéuticos Para Uso Humano  (current version);  
 Central American Technical Regulation RTCA Productos Farmacéuticos . Estudios De 
Estabilidad De Medicamentos Para Uso Humano  (current version);  G/TBT/N/PAN/100  
- 2 - 
   Central American Technical Regulation RTCA Productos Farma céuticos . 
Medicamentos Para Uso Humano . Verificación De La Calidad  (current version);  
 Central American Technical Regulation RTCA Productos Farmacéuticos . 
Medicamentos De Uso Humano . Buenas Prácticas De Manufactura Para La Industria 
Farmacéutica (current ve rsion) . 
9. Proposed date of adoption : Six months after publication in the Official Journal  
Proposed date of entry into force : 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 and email and website addresses, if available, of other body:  
Dirección General de Normas y Tecnología Industrial Ministerio de Comercio e Industrias 
(Directorate -General for Standards and Industrial Technolo gy, Ministry of Trade and 
Industry)  
Avenida Ricardo J. A lfaro, y calle El Paical, Edificio Plaza Edison, 3er Piso, Panamá.  
Tel.: (+507) 560 -0716, Ext. 5968/5964/5786  
Email:  
dgnti@mici.gob.pa ; uperez@minsa.gob.pa ; edcastillo@minsa.gob.pa  
Website : http://www.mici.gob.pa/  
Full text available online at:  
https://www.mici.gob.pa/documentos/dgnti/DGNTI -RTCA -11035918.pdf  
https://members.wto.org/crnattachments/2018/TBT/PAN/18_4358_ 00_s.pdf