G/TBT/N/BRA/1442  
26 August 2022  
(22-6462) 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/barrei rastecnicas  
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):  
Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of two or 
more constituents which have been mixed together for therapeutic or prophylactic uses, 
not put up in measured doses or in forms or packings for retail sale. (H S code(s): 3003); 
Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of mixed or 
unmixed products for therapeutic or prophylactic uses, put up in measured doses 
(including those in the form of transdermal administration systems) or i n forms or 
packings for retail sale. (HS code(s): 3004)  
5. Title, number of pages and language(s) of the notified document:  Draft resolution 
number 1108, 18 August 2022;; (20 page(s), in Portuguese)  
6. Description of content:  This Draft Resolution is reg arded to a proposal for a Normative 
Instruction that establishes the modalities and criteria applied for the optimized analysis 
procedure, in which the evaluations conducted by the Equivalent Foreign Regulatory 
Authority (EFRA) are used to analyze the mark et authorization and post -market 
authorization petitions of medicines and biological products, and a letter of adequacy of 
active pharmaceutical ingredient (CADIFA), in national territory.  
According to the proposal, it is designated as Equivalent Foreign R egulatory Authority 
(EFRA), the institution that has similar measures and controls in relation to the regulatory 
process adopted by Anvisa and meets, among other requirements, the adoption of 
international standards and norms equivalent to those currently adopted by Anvisa 
applicable to active pharmaceutical ingredient, medicines and biological products and 
their active substances, in particular those established by the International Council for 
Harmonisation  of Technical Requirements for Pharmaceuticals fo r Human Use ( ICH) 
and the World Health Organization (WHO);  G/TBT/N/BRA/1442  
 
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  7. Objective and rationale, including the nature of urgent problems where 
applicable:  Starting the discussion about the specific criteria for taking advantage of 
analyzes carried out by an Equivalent Foreign Regulatory Authority in the context of Drug 
and Biological Products General Office (GGMED) of Anvisa, it being necessary to define, 
by product category or type of service, the guidelines, criteria and procedures necessary 
for the adoptio n of abbreviated or optimized regulatory paths. Protection of human health 
or safety  
8. Relevant documents:  - 
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  
10. Final date for comments:  14 October 2022  
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/10181/6354042/CONSULTA+P%C3%9ABLICA+
N+1108+GGMED.pdf/876bfc10 -471d-464c-a8b6-7bfc0ea972de   
Comment form: https://pesquisa.anvisa.gov.br/index.php/899929?lang=pt -BR