G/TBT/N/BRA/708  
 
28 February 2017  
(17-1199) 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 (An visa) 
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 Metrol ogy, Quality and Technology (INMETRO)  
Telephone : +(55) 21 2563.2765  
Telefax : +(55) 21 2563.5637  
Email : barreirastecnicas@inmetro.gov.br   
Web-site: http://www.inmetro.gov.br/barreirastecnicas   
The comments to this Draft Regulation shall be sent 
to: http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=29985   
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) : Water for 
pharmaceutical use  
5. Title, number of pages  and language(s)  of the notified document : Draft Techn ical 
Resolution n° 312, 20 February  2017 (20 pages, in Portuguese)  
6. Description of content : This Draft Resolution defines the chapter "water for 
pharmaceutical purposes" of the Brazilian Pharmacopoeia.  
In this chapter it is considered water for pharmace utical use the various types of water 
used in the synthesis of ingredients; in the formulation and production of medicines; in 
laboratories; diagnostics and other applications related to health, including its use as the 
main component in the cleaning proce ss of utensils, equipments and systems.  
Purification process, storage and distribution of water must comply with the 
pharmacopoeia specifications. The water quality requirements will depend on its purpose 
and use, as well as the purification system designe d to meet the purity level established. 
The user is responsible for selecting the type of water appropriate to its objectives, as well 
as for the necessary controls to guarantee the maintenance of the desired quality.  
This chapter also addresses the two m ajor groups of water contaminants : chemical and 
microbiological contaminants.  
There are three types of water for pharmaceutical use : purified water (AP); water for 
injections (API) and ultra -purified water (AUP), whose monographs are found in this 
Pharmaco poeia. Official international compendiums specify, in addition to these, other 
types of water, such as : packaged in bottles, sterile or bacteriostatic, for irrigation or 
inhalation. However, all have purity characteristics similar to the three  fundamental types 
already mentioned.  G/TBT/N/BRA/708  
 
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  In addition to these, there are potable water and reagent water, which are widely used and 
have direct application in pharmaceutical facilities, mainly in general cleaning procedures. 
Thus, the five types of water are considered, i n relation to their main characteristics and 
application. Specific monographs, where available, detail purity parameters established for 
each type.  
7. Objective and rationale , including the nature of urgent problems where 
applicable : Protection of human h ealth or safety  
8. Relevant documents : (1) Brazilian Official Journal (Diário Oficial da Uniã o) N° 37, 
21 February 2017, section 1, page 38; (2) Resolution RDC Nº 59, 3 February 2016; 
(3) Brazilian Official Journal; (4) Not stated.  
9. Proposed date of ad option : 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 : 29 March 2017  
11. Texts available from : National enquiry point  [X] or address, telephone and fax 
number s and e mail and website address es, if available , of other body:  
Agency Responsible  
Brazilian Health Regulatory Agency (Anvisa)  
SIA, Trecho 5, Área Especial 57  
Brasília  – DF/Brazil  
CEP: 71.205 -050 
Phone. : +(55) 61 3462. 5402 
Website : http://www.anvisa.gov.br  
http://portal.anvisa.gov.br/documents/1 0181/2949405/CONSULTA+PUBLICA+N+312+COFA
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