G/TBT/N/BRA/617
5 February 2015 
(15-0766)  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 2563.2840 
Telefax: +(55) 21 2563.5637 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=19047  
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 applic able, otherwise national tariff heading. 
ICS numbers may be provided in  addition, where applicable): Products subject to 
health surveillance 
5. Title, number of pages and language(s) of the notified document: Draft Technical 
Resolution Nº 04, 22 January 2015, concerning the update of register data caused by corporate and commercial restructuration of companies (9 pages, in Portuguese) 
6. Description of content: Draft Technical Resolution Nº 04, 22 January 2015, concerning 
the update of register data caused by co rporate and commercial restructuration of 
companies.  
This draft Technical Resolution applies to corporate and commercial transactions between 
companies that perform the activities mentioned in the federal sanitary law and which result in the need to update register data regarding their operation and the 
ownership registration transferring of products under sanitary surveillance. It also applies 
to restructuration performed oversees, including MERCOSUR members. 
Once the corporate or commercial transaction is finalized, the successor company has 60 
days to deposit the necessary updating documents at Anvisa. 
This Draft Technical Resolution revokes Resolution RDC Nº 22/2010. 
7. Objective and rationale, including the nature of urgent problems where applicable: 
Protection of human health or safety  
8. Relevant documents:  Brazilian Official Journal (Diário Oficial da União), 27 January 2015; 
Section 1, p. 34, Draft Resolution (Consult a Pública) Nº 04, 22 January 2015, issued by 
Brazilian Health Surveillance Agency – Anvisa. When adopted, it will be published at the 
Brazilian Official Journal. Available in Portuguese. G/TBT/N/BRA/617 
 
- 2 - 
 
  9. Proposed date of adoption:   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: 4 March 2015 
11. Texts available from: National enquiry point [  ] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:   
Agency Responsible 
Brazilian Health Surveillance 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.b r/wps/wcm/connect/e18ccc004717045192239341cdd33a01/Consu
lta+P%C3%BAblica+n%C2%B0+04+GGREG.pdf?MOD=AJPERES