. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/BRA/383 
3 August 2010  
 (10-4131) 
Committee on Technical Barriers to Trade Original:   English 
  
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6. 
 
1. Member to Agreement notifying:  BRAZIL
  
If applicable, name of local governme nt involved (Article 3.2 and 7.2):     
2. Agency responsible:  Brazilian Sanitary Surveillance Agency – ANVISA 
Name and address (including telephone 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, Standard ization and Industrial Quality – INMETRO 
Telephone:  +(55) 21 2563.2821 Telefax:  +(55) 21 2502.6542 E-mail:  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):  Medicines. 
5. Title, number of pages and language(s) of the notified document:  Draft Resolution N° 72, 
14 July 2010 – brand names to identify medicines. (5 pages, in Portuguese) 
6. Description of content:  This technical regulation establishe s requirements for acceptability 
of medicines brand names and supplement di fferential names (additio ns to differ one 
medicine from another), and issues about the adequacy of brand names already registered at 
Anvisa.  This draft Resolution regulates the format ion of medicines brand names with the 
objective of identifying, mitigating and elimin ating the high health risk associated with 
medication errors resulting from the adoption of si milar names to differen t kind of medicines.  
The criteria set forth in this draft Resolution shall apply to all products that must submit to registration or notification at A nvisa.  The requirements set fort h here do not apply to generic 
medicines and immunotherapy, which shall use the common name of the active principle of 
the medicine.  The brand name, if applicable, must also attend the requirements set forth in 
the specific regulations that apply to specific  categories in which the applicant intend to 
register the medicine.  The defi nition of medicines brand name for the purpose of this draft 
Resolution is: name adopted to differentiate it from others of  the same company or other 
companies, proposed by the holder of the re gistration of the pharm aceutical product under 
which it is identified, sold and advertised.  S upplement differential name is defined as the 
complementary designation of a medicine brand name, with the function of diffe rentiating it 
from other products already registered by the company and reduce the risk of medication 
errors.  This draft Resolution revokes Re solution RDC No. 333, 19 November 2003.  G/TBT/N/BRA/383 
Page 2  
 
  7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of Human Health and Prevention of Deceptive Practices  
8. Relevant documents:   Brazilian Official Journal (Diári o Oficial da União), 16 July 2010; 
Section 1. Draft Resolution (Con sulta Pública) number 72, 14 July 2010, issued by Brazilian 
Sanitary Surveillance Agency – Anvisa; when  adopted, it will be published at 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:  16 August 2010 
11. Text available from: National enquiry point [ X  ], or address, telephone and fax 
numbers, e-mail and web-site addres ses, if available of the other body:    
National enquiry point 
Agency responsible Brazilian Sanitary Surveillance Agency – ANVISA SIA, Trecho 5, Área Especial 57 Brasília – DF / Brazil 
CEP:  71.205-050 
Tel.:  55 61 3462-5402 E-mail:  rel@anvisa.gov.br  Website:   http://www.anvisa.gov.br
 
http://portal.anvisa.gov.br /wps/wcm/connect/4c31738 043385f589fa7bf2fe0524184/CP+N%C
2%BA+72+GGMED.pdf?MOD=AJPERES