G/TBT/N/BRA/523  
 
29 January 2013  
(13-0525)  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 telephon e 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, Standardization and Industrial Quality - INMETRO 
Telephone:  +(55) 21 2563.2821 
Telefax:  +(55) 21 2502.6542 Email:  barreirastecnicas@inmetro.gov.br  
Website:  http://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):  
Pharmaceutical products. 
5. Title, number of pages and language(s) of the notified document:  Draft Resolution 
nº 01, 7 January 2013 - Granting and renewal of registration of medicines with synthetic 
and semi-synthetic active ingredients classified as new, generic and similar (22 pages, in 
Portuguese).     
6. Description of content:  This draft technical regulation establishes criteria and minimum 
documentation necessary for the granting and renewal of registration of medicines with synthetic and semi-synthetic active ingredients classified as new, similar and generic, in order to ensure the quality, safety and efficacy of these drugs.  
This draft technical regulation revokes Resolution RDC 136, 29 May 2003; Resolution 
RDC 16, 2 March 02nd 2007 (excepting items 1 and 2, VI, of Annex I); Resolution RDC 17, 2 March 2007 (excepting items 1 and 2, VI, of Annex) and articles 1 and 4 of Resolution 
RDC 210, 2 September 2004.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of Human Health  
8. Relevant documents:   Brazilian Official Journal (Diário Oficial da União), 8 January 2013; 
Section 1 p. 35  Draft Resolution (Consulta Pública) number 01, 7 January 2013, issued by 
Brazilian Health Regulatory Agency - Anvisa; When adopted, it will be published at  the  
Brazilian Official Journal. Available in Portuguese.   
9. Proposed date of adoption:   
 
Proposed date of entry into force:    To be determined after the end of the 
consultation period  
On the date of adoption. G/TBT/N/BRA/523 
 
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  10. Final date for comments:  15 April 2013 
11. Text available from:  National enquiry point [X], or address, telephone and fax 
numbers, e-mail and web-site addresse s, if available of the 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 
E-mail:  rel@anvisa.gov.br   
Website:  http://www.anvisa.gov.br  
"http://portal.anvisa.gov.br /wps/wcm/connect/9885ae804e1b282fa1f5b3c09d49251b/Con
sulta+P%C3%BAblica+n%C2%B0+ 1+GGMED.pdf?MOD=AJPERES "