G/TBT/N/BRA/584  
 
24 March 2014  
(14-1807)  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:  ANVISA - Brazilian Health Surveillance Agency 
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, Quality and Technology - INMETRO 
Telephone:  +(55) 21 2563.2821 
Telefax:  +(55) 21 2502.6542 Email:  barreirastecnicas@inmetro.gov.br  
Website:  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=14777   
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):  Medical 
devices, hygiene products, cosmetics, food and medicines. 
5. Title, number of pages and langua ge(s) of the notified document:  Draft Normative 
Instruction no. 08, 10 March 2014 that adop ts provisions on medical devices, hygiene 
products, cosmetics and food which manufacturing can be shared with medicines of human use, irrespective of previous authorization by ANVISA (4 pages, in Portuguese).     
6. Description of content:  Draft Normative Instruction nº 08, 10 March 2014 that adopts 
provisions on medical devices, hygiene products, cosmetics and food which 
manufacturing can be shared with medicines of human use, irrespective of previous 
authorization by ANVISA. 
The shared manufacturing of products not listed in this draft normative instruction 
depends on previous authorization by ANVISA, which must be required by specific code 
and instructed with supporting documents. This documentation can be complemented by a sanitary inspection if it is necessary to the conclusion about the shared manufacturing 
request. 
The previous authorization of products listed in this draft normative instruction doesn´t 
exempt companies from presenting su pporting documents whenever required. 
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of Human health or Safety G/TBT/N/BRA/584 
 
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  8. Relevant documents:   (1) Brazilian Official Journal (Diário Oficial da União), 
12 March 2014; Section 1, Draft Normative Instruction (Consulta Pública) number 08, 
10 March 2014, issued by Brazilian He alth Surveillance Agency - Anvisa 
(2) Not Applicable (3) Brazilian Official Journal; (4) Not Applicable. 
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:  17 April 2014 
11. Text available from:  National enquiry point [  ], 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://portal.anvisa.gov.b r/wps/wcm/connect/c0cb0c804341401ba056a188c37c37a1/Con
sulta+P%C3%BAblica+n%C2%B0+8+GGALI.pdf?MOD=AJPERES