G/TBT/N/BRA/574  
 
24  January 2014  
(14-0359)  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  
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 01, 16 January 2014 - Draft Resolution that defines rules to be adopted by register holders in order to establish the interchangeability between similar medicines and 
reference medicines (2 pages, in Portuguese).     
6. Description of content:  This draft Resolution aims to define rules to be adopted by 
register holders in order to establish the interchangeability between similar medicines 
and reference medicines. 
According to this draft technical Resolution, interchangeable similar medicines are those 
which pharmaceutical equivalence/bioavailability, bioequivalence and biowaiver studies 
had already been presented, analysed and approved by Anvisa. 
Register holders of interchangeable similar medicines will have up to 90 (ninety) days to 
notify Anvisa of labelling adequacy and to require the entry price definition, in 
accordance to the defined in this draft Re gulation. Changes in the packaging must be 
implemented in 180 (a hundred and eighty) da ys after the entry price is established. 
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), 
17 January 2014; Section 1, Draft Resolution (Consulta Pública) number 01, 16 January 
2014 (2) not Applicable; (3)  Brazilian Official Journal; (4) Not Applicable    G/TBT/N/BRA/574 
 
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  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:  24 February 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:    
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/20ddca8042979c349ae8db1bb0036de1/Con
uslta+P%C3%BAblica+n%C2%B0+ +1+DIMON+.pdf?MOD=AJPERES