G/TBT/N/BRA/594  
 
1 July 2014  
(14-3779)  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: Brazilian Health Surveillance Agency - ANVISA 
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 applic able, otherwise national tariff heading. 
ICS numbers may be provided in addition, where applicable): Medicines 
5. Title, number of pages and langua ge(s) of the notified document: Draft Resolution nº 
44, 18 June 2014, that disposes about the Certification of Good Practices in Bioavailability/Bioequivalence of medicines (6 pages, in Portuguese).  
6. Description of content: Draft Resolution to the revision of the Resolution nº 103/2003 
that disposes about the Certification of Good Practices in Bioavailability/Bioequivalence in medicines.  
This draft resolution establishes the requirements and administrative procedures to be 
attended to the Certification of Good Prac tices in Bioavailability/Bioequivalence of 
medicines and defines the studies of Bioavailability/Bioequivalence of medicines which 
must be realized in certified research centers.   
According to this draft resolution, the studies of bioavailability/bioequivalence for purposes 
of registration and post registration of medicines must be realized in certified research 
centers. All stages of the study must be realized in research centers which are certified by 
the Brazilian Health Surveillance Agency – ANVISA. 
The concession of the certification will depend on the verification of the effective fulfillment 
of the requirements preconized by the Good Practices of Bioavailability/Bioequivalence of 
Medicines, through inspection, documented in a report, in the respective research center 
which is the object of certification, and through a favorable technical opinion issued by 
ANVISA. 
The certification of Good Practices of Bioavailability/Bioequivalence can be suspended or 
canceled in cases when it is proved by the competent sanitary authority the non-fulfillment 
of the requirements preconized by the cu rrent regulation of Good Practices of 
Bioavailability/Bioequivalence. The solicitation of a new certification must be realized 
through a specific formulary of petition and the documents specified in it, available in the 
site of ANVISA. The new certification will be valid for 2 (two) years from the expiration of 
the previous certificate. G/TBT/N/BRA/594 
 
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  7. Objective and rationale, including the nature of urgent problems where applicable: 
Protection of Human Health  
8. Relevant documents:  Brazilian Official Journal (Diário Oficial da União), June 20th 2014; 
Section 1, p. 87, Draft Resolution (Consulta Pública) number 44, June 18th 2014, issued by 
Brazilian Health Surveillance Agency – Anvisa. When adopted, it will be published at the 
Brazilian Official Journal. Available in Portuguese. 
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: 25 August 2014 
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 
E-mail: rel@anvisa.gov.br   
Website:  
http://portal.anvisa.gov.b r/wps/wcm/connect/b9020500447118068d749f81581d3b02/Cons
ulta+P%C3%BAblica+n+44+C OBIO.pdf?MOD=AJPERES