G/SPS/N/BRA/1077  
 
1 December 2015  
(15-6345)  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: Brazilian Health Regulatory Agency - ANVISA 
3. Products covered (provide tariff item  number(s) as specified in national 
schedules deposited with the WTO; IC S numbers should be provided in 
addition, where applicable): Monetary update on registration and GMP certification 
fees related to health products 
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: Interministerial Ordinance nº 701, 31 August 2015, 
regarding a monetary update on registration and GMP certification fees related to health products in Brazil  Language(s): Portuguese  Number of pages: 4 
http://pesquisa.in.gov.br/imprensa/jsp/visua liza/index.jsp?data=02/09/2015&jornal=1&
pagina=26&totalArquivos=104  
6. Description of content: Interministerial Ordinance nº 701, 31 August 2015, regarding 
a monetary update on registration and GMP certification fees related to health products in Brazil. 
This Ordinance promoted a monetary update on registration and GMP certification fees 
related to health products in Brazil. It was necessary once the values of ANVISA's fees 
 
were obsolete since its creation in 1999, with accumulated losses of 193.5% according 
to Brazilian official inflation rate. So it is considered not to be a tribute increase, but a 
currency value reconstitution. 
7. Objective and rationale: [X] food safety, [ ] 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 st andard? If so, identify the standard:  
[ ] Codex Alimentarius Commission (e.g. title or serial  n u m b e r  o f  C o d e x  
standard or related text)   
[ ] World Organization for Animal Health (OIE) (e.g. Terrestrial or Aquatic 
Animal Health Code, chapter number)    
[ ] International Plant Protection Convention (e.g. ISPM number)    
[X] None 
Does this proposed regulation conform to the relevant international standard?   
[ ] Yes   [ ] No G/SPS/N/BRA/1077 
 
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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: 
The Brazilian Official Journal (Diário Oficial da União), 2 September 2015, 168th edition, 
Section 1, p. 26. Interministerial Ordinance number 701, 2 September 2015, issued by 
the Brazilian Finance Ministry (available in Portuguese). 
10. Proposed date of adoption (dd/mm/yy) : 9 September 2015 
Proposed date of publication (dd/mm/yy) : 2 September 2015 
11. Proposed date of entry into force: [ ] Six months from date of publication , 
and/or  (dd/mm/yy) : 9 September 2015 
[ ] Trade facilitating measure   
12. Final date for comments: [ ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : Not applicable 
Agency or authority designated to hand le comments: [ ] National Notification 
Authority, [X] National Enquiry Point. Address, fax number and e-mail address 
(if available) of other body:  
Patrícia Oliveira Pereira Tagliari 
Tel: +(55 61) 3462 5402/5404/5406 
E-mail: rel@anvisa.gov.br 
13. Text(s) available from: [ ] National Notifi cation Authority, [X] National Enquiry 
Point. Address, fax number and e-mail address (if available) of other body:   
Patrícia Oliveira Pereira Tagliari  
Tel: +(55 61) 3462 5402/5404/5406 E-mail: rel@anvisa.gov.br