G/TBT/N/BRA/1165  
26 April 2021  
(21-3516) 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 Code(s): 2941; 3003; 3004; 3005; (pharmaceutical products).  
5. Title, number of pages and language(s) of the notified document:   
Public Consultation No. 1044, 8 April 2021. (13 page(s), in Portugu ese). Draft:  
http://antigo.anvisa.gov.br/documents/10181/2695968/Minuta+1044.pdf/b63f7b1a -
f316-4f7d-b12c-acecfbbc5bf7  
Comment form:  https://pesquisa.anvisa.gov.br/index.php/948437?lang=pt -BR  
6. Description of content:  Public Consultation proposal to establish the criteria for the 
exemption and substitution of  relative bioavailability and bioequivalence studies.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health. The current regulation (RDC 37/2011) provide 
for three thematic areas for which the exemption is foreseen and replacement of 
bioequivalence studies: bioexemption due to pharmaceutical form; bioexemption for too 
many dosages; an d bioexemption based on the Biopharmaceutical Classification System 
(SCB). With the development of the scientific knowledge, it is necessary to provide for 
situations and restrictions on bio -disclaimer on the basis of the pharmaceutical form and 
other dosa ges, as well as updating the section related to the bioexemption theme based 
on the SCB of the normative the publication of the ICH M9 Guide in November/2019. 
Other countries are also updating their regulations in order to follow the requirements of 
ICH M9  Guide; Protection of human health or safety  G/TBT/N/BRA/1165  
 
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  8. Relevant documents:  01) Brazilian Official Gazette 65 -A on 08 April 2021, section 1, 
page 4; 02) Regulatory Impact Analysis (RIA) Report; 03) Justification for the draft 
resolution  
https://www.in.gov.br/web/dou/ -/consulta -publica -n-1.044 -de-8-de-abril-de-2021-
312902639  
http://antigo.anvisa.gov.br/documents/10181/2695968/REMAI.pdf/9f67b55f -3597-
4727-b045-2e9a3ca35077  
http://antigo.anvisa.gov.br/documents/10181/2695968/Justificativa+Regulat%C3%B3ri
a.pdf/0330657a -8e22-46bd-8d4b-2f421a9 4c27c  
9. Proposed date of adoption:  Not applicable  
Proposed date of entry into force:  Not applicable  
10. Final date for comments:  15 July 2021  
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  
http://antigo.anvisa.gov.br/documents/10181/2695968/Minuta+1044.pdf /b63f7b1a -
f316-4f7d-b12c-acecfbbc5bf7