G/SPS/N/BRA/1641  
 
7 April 2020  
(20-2762) 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; ICS numbers should be provided in addition, 
where applicable):  HS Code(s): 2106, 29, 2936, 2937, 2941, 3303, 3304, 3305, 3306, 
3307, 340111, 340130, 3402, 340119, 340120, 330290, 9616, 9619;  
ICS Code(s): 13, 65  
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 Resolution number 805, 27 March 2020 . 
Language(s):  Portuguese . Number of pages:  9 
Draft: http://portal.anvisa.gov.br/documents/10181/5833170/CP+805.pdf/ab194b8c -
fb14-473d-aa00-9035b6ad93a7  
Comment form: http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=54824  
6. Description of content:  This resolution establishes administrative procedure for the 
concession of  Good Manufacturing  Practices Certification for medicines, medical devices,  
personal hygiene products, cosmetics, perfumes, sanitizers, active pharmaceutical 
ingredients, and food; and Good Practices of Storage and Distribution Certification for 
medicines, medical devices, and  active pharmaceutical ingredients.  
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 standard? If so, identify the standard:  
[ ] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text) :  
[ ] Worl d 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 
If no, describe, whenever possible, how and why it deviates from the 
international standard:   G/SPS/N/BRA/1641  
 
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  9. Other relevant documents and language(s) in which these are available:  
10. Proposed date of adoption (dd/mm/yy) : In the date of its publication.  
Proposed date of publication (dd/mm/yy) : To be determined after the consultation 
period.  
11. Proposed date of entry into force: [  ] Six months from date of publication , 
and/or  (dd/mm/yy ): In the date of its publication.  
[ ] Trade facilitating measure   
12. Final date for comments: [  ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 5 August 2020  
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:   
Assessoria de Assuntos Internacionais - AINTE  
International Affairs Office  
Agência Nacional de Vigilância Sanitária - Anvisa  
Brazilian Health Regulatory Agency  
Tel: +(5561) 3462 5402/5404/5406  
E-mail: rel@anvisa.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:   
Assessoria de Assuntos Internacionais - AINTE  
International Affairs Office  
Agência Nacional de Vigilância Sanitária - Anvisa  
Brazilian Health Regulatory Agency  
Tel: +(5561) 3462 5402/5404/5406  
E-mail: rel@anvisa.gov.br