G/TBT/N/BRA/1088  
19 October 2020  
(20-7209) 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):  Antibiotics 
(HS 2941); Medicaments consisting of two or more constituents mixed together for 
therapeutic or prophylactic uses, not in measured doses or put up for retail sale (excl. 
goods of heading 3 002, 3005 or 3006) (HS 3003); Medicaments consisting of mixed or 
unmixed products for therapeutic or prophylactic uses, in measured doses or put up for 
retail sale (excl. goods of heading 3002, 3005 or 3006) (HS 3004); Wadding, gauze, 
bandages and the like , e.g. dressings, adhesive plasters, poultices, impregnated or 
covered with pharmaceutical substances or put up for retail sale for medical, surgical, 
dental or veterinary purposes (HS 3005); Pharmaceutical preparations and products of 
subheading Nos 3006. 10.10 to 3006.60.90 (HS 3006); True hemp "Cannabis sativa L.", 
raw or processed, but not spun; tow and waste of true hemp, incl. yarn waste and 
garnetted stock (HS 5302)  
5. Title, number of pages and language(s) of the notified document:  Normative 
Instruc tion number 71, 1 September 2020 (2 page(s), in Portuguese)  
6. Description of content:  This Normative Instruction establishes the inclusion of a 
declaration in the label of low risk notified medicines products, herbal medicinal products, 
and cannabis -based medicine  informing the existence of a new formula changing its 
composition.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety  G/TBT/N/BRA/1088  
 
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  8. Relevant documents:   
1) Brazilian Official Gazette 170 on 3 September 2020, section 1, page 75 2) Brazilian 
Official Gazette 170 on 03 September 2020, section 1, page 74 3) Resolution of the 
Collegiate Board - RDC No. 421 of 1 September 2020  
https://www.in.gov.br/web/dou/ -/instrucao -normativa -in-n-71-de-1-de-setembro -de-
2020-275656288  
https://www.in.gov.br/web/dou/ -/resolucao -de-diretoria -colegiada -rdc-n-421-de-1-de-
setembro -de-2020-275656506  
http://antigo.anvisa.gov.br/legislacao#/visualizar/432064  
9. Proposed date of adoption:  1 September 2021  
Proposed date of entry into force:  1 September 2021  
10. Final date for comments:  Not applied.  
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  
https://www.in.gov.br/web/dou/ -/instrucao -norm ativa-in-n-71-de-1-de-setembro -de-
2020-275656288