G/SPS/N/PAN/64  
31 January  2019 
(19-0571) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original:  Spanish  
 
  
NOTIFICATION  
1. Notifying Member : PANAMA  
If applicable, name of local government involved:  
2. Agency responsible : Ministerio de Desarrollo Agropecuario/Dirección Nacional de Salud 
Animal/ Departamento de Registro  (Ministry of Agricultural Development/National Animal 
Health Directorate/Registration Department)  
3. Products covered (provide tariff item number(s) as specified in national 
schedules deposited with the WTO ; ICS numbers sh ould be provided in addition, 
where applicable) : ICS number : 65.020.30  
4. Regions or countries likely to be affected, to the extent relevant or practicable:  
[X] All trading partners  
[ ] Specific regions or countries:   
5. Title of the notified document : RTCA 65.05.51:18 Reglamento Técnico 
Centroamericano (RTCA) Medicamentos Veterinarios y Productos Afines, Establecimientos 
que los Fabrican, Comercializan o Fraccionan . Requisitos de Registro Sanitario y Control  
(Central American Technical Regulation (RTCA) No. 65.05.51:18 : Veterinary drugs and 
related products, and establishments engaged in the manufacture, marketing or 
fractioning thereof . Sanitary registration and control requirements) . Language(s) : 
Spanish Number of pages : 81 
https://members.wto.org/crnattachments/2019/SPS/PAN/19_0490_00_s.pdf  
6. Description of content : The regulation applies to veterinary drugs and related products 
and to establishments engaged in the registration, manufacture, marketing, dispensing 
or distribution, fractioning or storage thereof in the States Parties.  
The sanitary registration of raw materials for the preparation of veterinary drugs and 
related prod ucts and compounded veterinary formulations is excluded from the scope of 
the regulation and remains subject to the domestic laws of each State Party.  
7. Objective and rationale : [ ] food safety , [X] animal health , [ ] plant protection, 
[ ] protect humans  from animal/plant pest or disease, [ ] protect territory from 
other damage from pests.  
8. Is there a relevant international standard ? If so, identify the standard:  
[ ] Codex Alimentarius Commission (e.g. title or serial number of Codex 
standard or relat ed text) : 
[ ] World Organisation for Animal Health (OIE) (e.g. T errestrial or Aquatic 
Animal Health Code, chapter number) : 
[ ] International Plant Protection Convention ( e.g. I SPM No. ): 
[X] None  G/SPS/N/PAN/64  
- 2 - 
  Does this proposed regulation conform to the relevant international standard?  
[ ] Yes [ ] No 
If no, describe, whenever possible, how and why it deviates from the 
international standard:   
9. Other relevant documents and language(s) in which these are available:  
10. Proposed date of adoption (dd/mm/yy) : To be determined  
Proposed date of publication (dd/mm/yy) : To be determined  
11. Proposed date of entry into force : [ ] Six months from date of publication, and/or 
(dd/mm/yy ): To be determined  
[ ] Trade facilitating measure  
12. Final date for comments : [X] Sixty days from the date of circulation of the 
notification and/o r (dd/mm/yy ): 1 April 2 019 
Agency or authority designated to handle comments : [ ] National Notification 
Authority, [X]  National Enquiry Point . Address, fax number and email address 
(if available) of other body:  
Ministerio de Desarrollo Agropecuario  (Ministry of Agricultural Development)  
Departamento de Registro  (Registration Department)  
Dirección Nacional de Salud Animal , DINASA (National Animal Health Directorate)  
Tel.: (+507) 524 2214  
Email : jdonado@mida.gob.pa  
13. Text(s) available from : [ ] National Notification Authority, [X]  National Enquiry 
Point . Address, fax number and email address (if available) of other body:  
Ministerio de Desarrollo Agropecuario  
Departamento de Registro  
Dirección Nacional de Salud Animal/DINASA  
Tel.: (+507) 524 2214  
Email:  jdonado@mida.gob.pa  
 dgnti@mici.gob.pa  
 
https://www.mici.gob.pa/uploads/media_ficheros/2019/01/6/direcion -
general/aviso/noti -2/rtca -reg-medicamentos -veterinarios -cp.pdf