G/TBT/N/BRA/524  
 
29 January 2013  
(13-0526)  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  
Web-site: 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):  Medicines, 
Health Products, Cosmetics, Perfumes, Pe rsonal Care Products, Sanitizing and 
Pharmaceutical Active Ingredients. 
5. Title, number of pages and language(s) of the notified document:  Draft Resolution 
nº 02, 7 January 2013 - Granting of Certificate of Good Manufacturing Practices and 
Certification of Good Distribution Practices and/or Storage (11 pages, in Portuguese).     
6. Description of content:  This draft technical regulation establishes conditions for the 
granting of Certification of Good Manufacturing Practices for Medicines, Health Products, Cosmetics, Perfumes, Personal Care Products, Sanitizing and Pharmaceutical Active 
Ingredients. It also establishes the conditions for the granting of Certification of Good 
Distribution Practices and/or Storage for Medicines, Health Products and Active 
Ingredients.  
This draft technical regulation revokes Resolution RDC 460, 14 September 1999; Annex II 
of Resolution RDC 25, 9 December 1999; Resolution RDC 95, 8 November 2000; 
Resolution RE 1.450, 11 September 2001; Resolution RDC 354, 23 December 2002; Resolution RDC 225, 25 August 2003; Resolution RDC 66, 5 October 2007; Resolution 
RDC 16, 23 April 2009; Resolution RDC 68, 21 December 2009, and Resolution RDC 29, 
10 August 2010.  
Petitions for extension of the Certificate of Good Manufacturing Practices for Health 
Products filed until the date of publication of this Resolution shall be evaluated in 
accordance with the requirements of Resolution RDC 16, 23 April 2009. 
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of Human Health  G/TBT/N/BRA/524 
 
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  8. Relevant documents:   Brazilian Official Journal (Diário Oficial da União), 8 January 2013; 
Section 1 p. 35  Draft Resolution (Consulta Pública) number 02, 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 
10. Final date for comments:  18 March 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:    
National enquiry point 
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/conne ct/fcd35d004e1b2885a1feb3c09d49251b/Cons
ulta+P%C3%BAblica+n%C2%B0+2+GGIMP.pdf?MOD=AJPERES "