G/TBT/N/BRA/611
28 October 2014 
(14-6250)  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 2563.2821 
Telefax: +(55) 21 2502.6542 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=17911  
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): Centres of 
pharmaceutical equivalence 
5. Title, number of pages and language(s) of the notified document: Draft Technical 
Resolution nº 95, October 9th 2014, Regarding the Petitions of Request for Qualification, License Renewal, Post-License Changes, Outsourcing Trial, Suspensions and Cancellations of Centres of Pharmaceutical Equivalence (22 pages, in Portuguese) 
6. Description of content: Draft Technical Resolution nº 95, 9 October 2014, regarding the 
petitions of request for qualification, license renewal, post-license changes, outsourcing 
trial, suspensions and cancellations of Centres of Pharmaceutical Equivalence (22 pages, in 
Portuguese).  
This draft Technical Resolution establishes the minimum requirements and procedures to 
be attended by laboratories that intend to become Centres for Pharmaceutical Equivalence, 
and by the ones that are already licensed, to the request for qualification, license renewal, post-license changes, outsourcing trial, suspensions and cancellations of Centres of 
Pharmaceutical Equivalence. 
The Centres of Pharmaceutical Equivalence already qualified have 120 days after the 
publication of the regulation to make the necessary adjustments, in order to comply with this Draft Technical Resolution. 
This Draft Technical Resolution revokes article 4
th and its paragraphs 1st and 2nd, of the 
Resolution RDC n. 41/2000. G/TBT/N/BRA/611 
 
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  7. Objective and rationale, including the nature of urgent problems where applicable: 
Protection of human health or safety  
8. Relevant documents:  Brazilian Official Journal (Diário Oficial da União), 10 October 2014; 
Section 1, p. 45, Draft Resolution (Consulta Pública) number 95, 9 October 2014, issued by Brazilian Health Surveillance Agency – ANVI SA. 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: 17 November 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 
Website: http://www.anvisa.gov.br 
http://portal.anvisa.gov.br/wps/wcm/connect/cb9eab8045c7dcc89f87ffd10ee53f37/Consulta
+P%C3%BAblica+n%C2%B0+95+GGMED.pdf?MOD=AJPERES