  
  
G/TBT/N/BRA/997  
9 April 2020  
(20-2834) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  English  
 
  NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  BRAZIL   
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:   
National Institute of Metrology, Quality and Technology (INMETRO)  
Telephone: +(55) 21 2145.3817  
Email: barreirastecnicas@inmetro.gov.br   
Web-site: www.inmetro.gov.br/barreirastecnicas  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:   
Brazilian Health Regulatory Agency (ANVISA)  
3. Notified under Article 2.9.2 [X], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other :  
4. Products covered (HS or CCCN  where applicable, otherwise national tariff 
heading. ICS numbers may 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  
5. Title, numb er of pages and language(s) of the notified document:  Draft Resolution 
number 805, 27 March 2020  (9 page(s), in Portuguese)  
Comment form: http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=54824   
6. Description of content:  This resolution esta blishes 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, including the nature of urgent problems where 
applicable:  Protection of human health  
8. Relevant documents:  (1) Brazilian Official Gazette (Diário Oficial da União) 63, 01 April 
2020, section 1, page 103; (2) Not stated; (3) Brazilian Official Gazette; (4) Not stated.  
9. Proposed date of adoption:  In the date of its publication  
Proposed date of entry into force:  In the date of its publication  
10. Final date for comments:  5 August 2020  G/TBT/N/BRA/997  
 
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  11. Texts available from:  National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
Brazilian Health Regulatory Agency (Anvisa)  
SIA, Trecho 5, Área Especial 57  
Brasília – DF / Brazil  
CEP: 71.205 -050 
Phone.: +(55) 61 3462.5402  
Website: www.anvisa.gov.br  
http://portal.anvisa.gov.br/documents/10181/5833170/CP+805.pdf/ab194b8c -fb14-473d-
aa00-9035b6ad93a7  
 