  
  
G/TBT/N/BRA/900  
21 August 2019  
(19-5366) 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 2563.2918  
Telefax: +(55) 21 2563.5637  
Email: barreirastecnicas@inmetro.gov.br   
Website: 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 indicat ed 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: 
29; 30. (active pharmaceutical ingredients)  
5. Title, number of pages and language(s) of the notified document:  Draft Resolution 
number 688, August 12th, 2019. Published on D.O.U, August 14t h, 2019. Language(s): 
Portuguese. Number of pages: 6. Comment form: 
http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=49406  
6. Description of content:  This d raft resolution establishes criteria for certification of Good 
Manufacturing Practice for international companies that manufacture Active Pharmaceutical 
Ingredients (API).  
7. Objective and rationale, including the nature of urgent problems where 
applicab le: Protection of Human Health; Protection of human health or safety  
8. Relevant documents:   
1. Brazilian Official Journal (Diário Oficial da União), 14 August 2019, section 1, 
number  156; Page 74. Not stated; 3.Brazilian Official Journal; 4 Not stated.  
9. Proposed date of adoption:  To be determined after the end of the consultation period.  
Proposed date of entry into force:  In the date of its publication.  
10. Final date for comments:  21 October 2019  G/TBT/N/BRA/900  
 
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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 3462.54 02 
Website: www.anvisa.gov.br  
http://portal.anvisa.gov.br/documents/10181/51823 31/Consulta+Pu%C2%B4blica+688.p
df/c2a75b20 -c7b2-4490-bfb8-140c80621f20  
 