  
  
G/TBT/N/BRA/1369  
12 April 2022  
(22-2966) 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 [  ], 3.2 [  ], 7.2 [  ], 
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) - Medicaments  
5. Title, number of pages and language(s) of the notified document:  Normative 
Instruction number 133, 30 March 2022; (3 page(s), in Portuguese)  
6. Description of content:  This normative instructio n contains provisions on Good 
Manufacturing Practices complementary to Pressurized Aerosol Medicines Metered for 
Inhalation  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety  
8. Relevant documents:   
- 
9. Proposed date of adoption:  2 May 2022  
Proposed date of entry into force:  2 May 2022  
10. Final date for comments:  Not applied  G/TBT/N/BRA/1369  
 
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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  
CEP: 71.205 -050 
Phone.: +(55) 61 3462.5402  
Website: www.a nvisa.gov.br  
  
http://antigo.anvisa.gov.br/documents/10181/6415119/IN_133_2022_.pdf/558c8c4e -
7d92-4ba5-8f53-6cc907d720e5  
 