G/TBT/N/BRA/1056  
6 August 2020  
(20-5450) 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  
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):  
Medicaments (excluding goods of heading No. 3002, 3005 or 3006) consisting of two or 
more constituents which have been mixed together for therapeutic or prophylactic uses, 
not put up in measured doses or informs or packings for  retail sale (HS 3003); 
Medicaments (excluding goods of heading No. 3002, 3005 or 3006) consisting of mixed or 
unmixed products for therapeutic or prophylactic uses, put up in measured doses or in 
forms or packings for retail sale (HS 3004); Wadding, gauze , bandages and similar articles 
(for example, dressings, adhesive plasters, poultices), impregnated or coated with 
pharmaceutical substances or put up in forms or packings for retail sale for medical, 
surgical, dental or veterinary purposes (HS 3005); Phar maceutical goods specified in 
Note 3 to this Chapter (HS 3006)  
5. Title, number of pages and language(s) of the notified document:  Draft Resolution 
number 889, 24 July 2020. (19 page(s), in Portuguese)  
Comment form: http://formsus.datasus.gov.br/site/form ulario.php?id_aplicacao=58183  
6. Description of content:  This draft resolution establishes technical requirements for the 
notification, market authorization, and post market authorization for medicinal gases.   
7. Objective and rationale, including the nature of urgent problems where 
applicable:   
http://portal.anvisa.gov.br/documen ts/10181/3428523/%281%29Justificativa+regulat%C
3%B3ria+_+CP+889+e+890.pdf/2cb3fc21 -208e-4591-ba64-ad6bdbf4b675  
Protection of human health or safety  
8. Relevant documents:  1) Brazilian Official Gazette N° 144, 29 July 2020, Section 1, 
Page 74 G/TBT/N/BRA/1056  
 
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  9. Proposed date of adoption:  To be determined after the end of the consultation period  
Proposed date of entry into force:  To be determined after the end of the consultation 
period  
10. Final date for comments:  5 October 2020  
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://portal.anvisa.gov.br/documents/10181/3428523/CONSULTA+P%C3%9ABLICA+N+
889+GGMED.pdf/ac51a507 -bb83-493d-bc98-23289837cda3