G/TBT/N/BRA/1094  
29 October 2020  
(20-7603) 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):  
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 for transdermal 
administration" or in forms or packings for retail sale (excl. goods of heading 3002, 3005 
or 3006) (HS 3 004); 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 
prepar ations and products of subheadings 3006.10.10 to 3006.60.90 (HS 3006)  
5. Title, number of pages and language(s) of the notified document:  Draft Normative 
Instruction number 931, 13 October 2020 (4 page(s), in Portuguese)  
Comment form: http://formsus.datas us.gov.br/site/formulario.php?id_aplicacao=60163  
6. Description of content:  This draft normative instruction establishes new codes for the 
administrative request of market authorization for new and innovative synthetic and 
semisynthetic medicines.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  RDC No. 60, of 10 October 2014, had the criteria for granting and renewing 
the registration of drugs with synthetic and semisynthetic active ingredients, classified as 
new, generic and similar. The resolution brought greater regulatory robustness in 
understanding what is expected as proof of quality and safety and efficacy in the 
registration of synthetic and semisynthetic drugs in relation to previous regulations. 
However, t he possible categories of registration by RDC 60/2014 were New Drug, New 
Association, New Fixed Dose Association, New Pharmaceutical Form, New Concentration, 
New Route of Administration, Drug with Same(s) IFA(s) Of New Drug Already Registered, G/TBT/N/BRA/1094  
 
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  Generic and Similar. For this categorization, RDC No. 60/2014 made it impossible to frame 
some drugs that brought an innovation that did not fall into any of the categories defined 
in the resolution, creating an administrative -regulatory – and non -technical – obstacle  to 
the entry of innovative drugs into the national market. This situation was a constant 
demand of the regulated sector and brought internal discussion about the need for a 
broad revision of the standard.; Protection of human health or safety  
8. Relevant  documents:  1) Brazilian Official Gazette 204 on 23 October 2020, section 1, 
page 480; 2) Report of Impact Assessment  
https://www.in.gov.br/web/dou/ -/consulta -publica -n-931-de-13-de-outubro -de-2020-
284700465  
http://antigo.anvisa.gov. br/documents/10181/5457402/Relat%C3%B3rio+de+Mapeam
ento+de+Impactos+ -+REMAI+ -+CP+931 -2020.pdf/5d99a3f0 -3230-453e-be85-
5e509842290c  
9. Proposed date of adoption:  To be defined  
Proposed date of entry into force:  To be defined  
10. Final date for comments:  28 December 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://antigo.anvisa.gov.br/documents/10181/5457402/CONSULTA+P%C3%9ABLICA+
N+931+COINC.pdf/3166ca86 -fa37-4581-af7a-7c06ea8ebd78