G/SPS/N/BRA/1522  
 
5 June 2019  
(19-3856) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  
NOTIFICATION  
1. Notifying Member:  BRAZIL  
If applicable, name of local government involved:   
2. Agency responsible:  Secretariat of Animal and Plant Health and Inspection (SDA) - 
Ministry of Agriculture, Livestock and Food Supply (MAPA)  
3. Products covered (provide tariff item number(s) as specified in national 
schedules deposited with the WTO; ICS numbers should be pr ovided in addition, 
where applicable):  Biological products for veterinary use  
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:  Draft Normative Instruction that establishes the 
procedures and conditions for carrying out stability studies for registration or post -
registration amendments of biological products for veterinary use . Language(s):  
Portuguese . Number of pages:  2 
http://pesquisa.in.gov.br/imprensa/jsp/visualiza/index.jsp?data=25/04/2019&jornal=51
5&pagina=4&totalArquivos=60  
https://members.wto.org/crnattachments/2019/SPS/BRA/19_3261_00_x.pdf  
6. Description of content:  The notified document submits to Public Consultation, a draft 
of Normative Instruction for the establishment of the procedures and conditions for 
carrying out stability studies for registration or post -registration amendments of biological 
products for veterinary use.  
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 related text) :  
[X] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, chapter number) : Terrestrial Manual Chapters 1.1.8, 
1.1.9, 2.3.4, 2.3.5  
[ ] International Plan t Protection Convention (e.g.  ISPM number) :  
[ ] None  
Does this proposed regulation conform to the relevant international standard?  
[X] Yes   [  ] No G/SPS/N/BRA/1522  
 
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  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 defined.  
Proposed date of publication (dd/mm/yy) : To be defined.  
11. Proposed date of entry into force: [  ] Six months from date of publication , 
and/or  (dd/mm/yy) : To be defined.  
[X] Trade facilitating measure   
12. Final date for comments: [X]  Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 4 August 2019  
Agency or authority designated to handle comments:  [ ] National Notification 
Authority, [X]  National Enquiry Point. Address, fax number and e -mail address 
(if available) of other body:   
Ministry of Agriculture, Livestock and Food Supply  
Secretariat of Agribusiness International Relations  
E-mail: sps@agric ultura.gov.br  
13. Text(s) available from: [  ] National Notification Authority, [X]  National Enquiry 
Point. Address, fax number and e -mail address (if available) of other body:   
Ministry of Agriculture, Livestock and Food Supply  
Secretariat of Agribusiness  International Relations  
E-mail: sps@agricultura.gov.br