. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/BRA/388 
21 September 2010  
 (10-4774) 
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, Standa rdization and Industrial Quality-INMETRO 
Tel.:  +(55) 21 2563 2821 
Fax:  +(55) 21 2502 6542 Email:  barreirastecnicas@inmetro.gov.br
 
Website:  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 nº 86, 
12 August 2010 - Registration Re quirements for Specific Medicines (17 pages, in 
Portuguese). 
6. Description of content:  This technical regula tion establishes proced ures and requirements 
for registration at Anvisa of specific medicines. 
This draft resolution has the objective to defi ne the category of specific medicines and 
establish minimum requi rements for registration and renewa l of this category at Anvisa. 
This draft resolution applies to all products de fined in Article 5 as specific medicines. 
According to this Resolution, it shall be co nsidered specific medicines pharmaceutical 
products technically obtained or developed with prophylactic, curative or palliative 
objectives, as typified in Article 5 of this Resolution.  
Article 5 of the Resolution expressly defines what  kind of medicines are classified as specific 
medicines. Among others, it is defined as su ch: irrigation solutions, dialysis, plasma 
expanders, concentrated polyelectrolyte for Hem odialysis;  parenteral nut rition;  solutions of 
large and small volume, parenteral or not, such  as water for injection, glucose solutions, 
sodium chloride, other electrolytic compounds or sugars and polyal cohols; products that 
prevent dehydration and to maintain hydration;  antiacid drugs; medicines based on vitamins 
and/or minerals; and others. G/TBT/N/BRA/388 
Page 2  
 
  Medicines that belong to the category of specif ic medicine can not apply for registration at 
Anvisa as generic, herbal, spurred, similar or new medicine.  
The requirements on this Resolution shall not a pply to drugs classified as generic, herbal, 
spurred, similar or new medicine. 
Articles 40 to 46 define regist ration procedures for imported products produced in foreign 
countries.  
For applications already submitted to Anvisa it will be granted a period of 6 (six) months to 
protocol the required adjustments to comply with  this resolution, after its entry into force. 
This resolution will revoke  Anvisa ´s Resolution RDC nº 132, 29 May 2003. 
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 (Diá rio Oficial da União), 12 August 2010; 
Section 1. Draft Resolution (Consulta Públic a) number 86,  10 August 2010, issued by 
Brazilian Sanitary Surv eillance 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:  13 September 2010 
11. Text available from: National enquiry point [X], or address, telephone and fax numbers, 
e-mail and web-site addresses, 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 Email:  rel@anvisa.gov.br  
Website:  http://www.anvisa.gov.br
 
 http://portal.anvisa.gov.br/wps/wcm /connect/bd4dec80438e 99d9bf22bf07ebd78d7a/CP+N%
C2%BA+86+GGMED.pdf?MOD=AJPERES