  
  
G/TBT/N/BRA/1276  
28 October 2021  
(21-8167) 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:  Brazilian Health Regulatory Agency (ANVISA)  
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:   
National Institute of Metrology, Quality and Technology (INMETRO)  
Telephone: +(55) 21 2145.3817  
Telefax: +(55) 21 2563.5637  
Email: barreirastecnicas@inmetro.gov.br   
Web-site: www.inmetro.gov.br/barreirastecnicas  
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 (3003, 
3004, and 3006) – Medicaments and Medical devices  
5. Title, number of pages and language(s) of the notified document:  Ordinance 
number 538, 15 October 2021 (1 page(s), in Portuguese)  
6. Description of content:  This ordinance delegates competence to carry out inspections 
to verify compliance with the Good Manufacturing Practices of manufacturers of health 
products of risk class III and IV and medicines, except medicinal gases, for the purpos e 
of issuing the Operating Permit and the Certificate of Good Manufacturing Practices.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety  
8. Relevant documents:   
Not applicable  
9. Proposed date of adoption:  In the date of its publication (15 October 2021)  
Proposed date of entry into force:  In the date of its publication (15 October 2021)  
10. Final date for comments:  Not applicable  G/TBT/N/BRA/1276  
 
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  11. Texts available from:  National enquiry point [ ] 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  
ZIP CODE: 71.205 -050 
Phone.: +(55) 61 3462.5402  
Website: www.anvisa.gov.br  
https://www.in.gov.br/en/web/dou/ -/porta ria-pt-n-538-de-15-de-outubro -de-2021-
353049646  
 