G/TBT/N/BRA/1030  
29 June 2020  
(20-4482) 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:   
Nation al 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):  
HS Code(s): 3003; 3004; 3005; 2941 (pharmaceutical products); 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 
3002, 3005 or 3006) (HS 3003); Medicaments consisting of mixed or unmixed products for 
therapeutic or prophylactic uses, put up in measured doses "incl. those in the form of 
transdermal administration" or in forms or packings for re tail 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, den tal or veterinary purposes (HS 3005)  
5. Title, number of pages and language(s) of the notified document:  Draft Normative 
Instruction no. 816, 01 June 2020 (9 page(s), in Portuguese)  
6. Description of content:  This draft resolution establishes technical r equirements 
for labelling of large -volume parenteral solutions, solutions for irrigation, dialysis,  plasma 
expanders and small -volume parenteral solutions.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of  human health; Protection of human health or safety  
8. Relevant documents:  (01) Published in the Brazilian Official Gazette 105, on 03 Jun e 
2020, section 1, page 502.   
9. Proposed date of adoption:  On the date of the publication of the final text  
Proposed date of entry into force:  On the date of the publication of the final text  
10. Final date for comments:  7 September 2020  G/TBT/N/BRA/1030  
 
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  11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
Draft: 
http://portal.anvisa.gov.br/documents/10181/3426875/CONSULTA+P%C3%9ABLICA+N+
816+DIRE+2.pdf/a1a41bb9 -78e0-4157-9b4a-605aa0a8c527  
Comment form: http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=56967  
 
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/10181/3426875/CONSULTA+P%C3%9ABLICA+N+
816+DIRE+2.pdf/a1a41bb9 -78e0-4157-9b4a-605aa0a8c527