G/TBT/N/BRA/630  
 
23 March 2015  
(15-1626)  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  
Web-site: 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=19729   
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): Industrialized allergenic 
products of biological origin 
5. Title, number of pages and language(s) of the notified document: Draft Technical 
Resolution nº 19, 10 March 2015, Regarding th e Registration and Post -Approval Changes of 
Industrialized Allergenic Products of Biological Origin (17 pages, in Portuguese) 
6. Description of content: Draft Technical Resolution nº 19, 10 March 2015, Regarding the 
Registration and Post-Approval Changes of Indust rialized Allergenic Products of Biological 
Origin.  
This Draft Technical Resolution aims to establish the minimum requirements to the 
registration and post-approval changes of indust rialized allergenic products of biological 
origin, in order to ensure quality, sa fety and efficacy of these products. 
This Resolution applies to industrialized allergenic products of biological origin that will be 
submitted to the registration analysis an d post-approval changes of those products, 
besides regulating nominal allergenic products and their use by qualified professional. 
This Resolution revokes the Resolution RDC nº 233/2005. 
7. Objective and rationale, including the nature of urgent problems where applicable: 
Protection of human health or safety  
8. Relevant documents:  1) Brazilian Official Journal (Diário Oficial da União), 
11 March 2015; Section 1, p. 78; 2) Resolution RDC nº 55/2010, Resolution 
RDC nº 47/2009, Resolution RDC nº 71/2009, Resolution RDC nº 49/2011, Law nº 6.437, 
20 August 1977; 3) Brazilian Official Journal; 4) Not Stated. G/TBT/N/BRA/630 
 
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  9. Proposed date of adoption: To be determined after the end of the consultation period 
Proposed date of entry into force: 90 days after the publication   
10. Final date for comments: 18 May 2015 
11. Texts available from: Nati onal enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:  
Agency Responsible 
Anvisa – Brazilian Health Surveillance Agency 
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/8f190300479abb288ba4ebfe096a5d32/CP+19
-2015+-+Minuta.pdf?MOD=AJPERES