G/SPS/N/GTM/45/Add.1  
30 January  2019 
(19-0498) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original:  Spanish  
 
  
NOTIFICATION  
Addendum  
The following communication, received on 2 8 January 2 019, is being circulated at the request of the 
delegation of Guatemala . 
 
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Central American Technical Regulation (RTCA) No. 65.05.51:08 : Veterinary drugs and related 
products . Sanitary registration and control requirements  
On 5 January 2 009, the Government of the Republic of Guatemala notified, in document 
G/SPS/N/GTM/45, the draft regulation " RTCA No. 65.05.51.08 : Veterinary drugs and related 
products . Sanitary registration and control requirements", whose purpose was to establish 
provisions governing the sanitary registration and control of veterinary drugs, related products 
and establishments . 
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 
products and compounded veterinary formulations is excluded from the scope of the regulation 
and remains subject to the domestic laws of each State Party.  
The purpose of the present addendum is to notify WTO Members that the regulation has been 
updated . They will have 60 days from the date of this notification to make comments.  
This addendum concerns a:  
[ ] Modification of final date for comments  
[ ] Notification of adoption, publication, or e ntry into force of regulation  
[X] Modification of content and/or scope of previously notified draft regulation  
[ ] Withdrawal of proposed regulation  
[ ] Change in proposed date of adoption, publication, or date of entry into force  
[ ] Other:  
Comment  period : (If the addendum extends the scope of the previously notified 
measure in terms of products and/or potentially affected Members, a new deadline for 
receipt of comments should be provided, normally of at least 60 calendar days . Under 
other circumsta nces, such as extension of originally announced final date for 
comments, the comment period provided in the addendum may vary.)  
[X] Sixty days from the date of circulation of the addendum to the notification and/or 
(dd/mm/yy ): 31 March 2 019 G/SPS/N/GTM/45/Add.1  
- 2 - 
  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:  
 
Text(s) available from : [ ] National Notification Authority, [X]  National Enqui ry Point . 
Address, fax number and email address (if available) of other body:  
Coordinación de Integración Económica  (Economic Integration Coordination Office)  
8ª. Ave. 10 -43 Zona 1, 4to . Nivel 
Ciudad de Guatemala  
Tel.: (+502) 2412 0200, Ext. 4319  
Fax: (+502) 2412 0339  
Email : ljuarez@mineco.gob.gt  
Website: http://www.mineco.gob.gt/  
 
Departamento de Registro de Medicamentos Veterinarios y Alimentos para Animales  (Veterinary 
Drug and Animal Feed Registration Departm ent) 
Ministerio de Agricultura, Ganadería y Alimentación , MAGA (Ministry of Agriculture, Livestock and 
Food)  
6ta. Avenida 12 -90, Zona 13  
Ciudad de Guatemala  
Tel.: (+502) 2413 7000  
Email : mariaeugeniapazvet@gmail.com  
Website : http://www.maga.gob.gt/  
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