G/TBT/N/BRA/1468  
 
5 January 2023  
(23-0138) 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):  
Pharmaceutics (ICS code(s): 11.120)  
5. Title, number of pages and language(s) of the notified document:  Draft resolution 
number 1135, 23 December 2022; (6 page(s), in Portuguese)  
6. Description of content:  This Draft Resoluti on is regarded to a regulatory proposal for 
the establishment of specific criteria and procedures for defining the Equivalent Foreign 
Regulatory Authorities of the sanitary inspection process of manufacturers of active 
pharmaceutical ingredients, Cannabis products for medicinal purposes, medicines and 
biological products. And the optimized Good Manufacturing Practices (GMP) Certification 
review process.  
The Regulatory Trust Building Program for the recognition of the equivalence of the health 
inspection processes of an AREE is applicable exclusively to regulatory authorities or 
member entities of the Pharmaceutical Inspection Co -operation Scheme (PIC/S) and the 
International Council for Harmonisation of Technical Requirements for Pharmaceutical s 
for Human Use (ICH).  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Establishing specific normative acts that define the Equivalent Foreign 
Regulatory Authorities (AREE) and the conditions for admitting analyzes ca rried out by 
these AREE in an optimized procedure, according to each type of health surveillance 
process or product category.; Protection of human health or safety  
8. Relevant documents:  - G/TBT/N/BRA/1468  
 
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  9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  
10. Final date for comments:  6 March 2023  
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.anvisa.gov.br  
The final text is available only in Portuguese and can be downloaded at:  
Draft: 
http://antigo.anvisa.gov.br/documents/10181/6531690/CONSULTA+P%C3%9ABLICA+
N+1135+GIMED.pdf/b683dddc -9016-4adc-978f-a8d557b95347  Comment form: 
https://pesquisa.anvisa.gov.br/index.php/575119?lang=pt -BR