G/TBT/N/BRA/618
5 February 2015 
(15-0767)  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  
The comments to this Draft Regulation shall be sent to: 
http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=19091  
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): Pharmaceutical 
substances under special control and medicines containing them 
5. Title, number of pages and language(s) of the notified document: Draft Technical 
Resolution Nº 05, 28 January 2015, Regarding the Control of Substances Under Special Control, and Medicines Containing Them, in Pharmaceutical Equivalence Centres and Centres of Bioavailability/Bioequivalence (7 pages, in Portuguese) 
6. Description of content: Draft Technical Resolution Nº 05, 28 January 2015, regarding the 
control of substances under special control, and medicines containing them, in 
Pharmaceutical Equivalence centres and centres of Bioavailability/Bioequivalence.  
According to this draft Technical Resolution, the licensed Pharmaceutical Equivalence 
centres and the centres of Bioavailability/Bioeq uivalence certified by Anvisa must obtain 
Special Authorization to the execution of an y activities which involve substances under 
special control and the medicines containing them as well. 
The establishments have 1 (one) year to ask for the Special Authorization and 3 (three) 
months to adapt themselves to the other requirements of this draft Technical Resolution.  
This Draft Technical Resolution revokes the Resolution RDC Nº 197/2004. 
7. Objective and rationale, including the nature of urgent problems where applicable: 
Protection of human health or safety  G/TBT/N/BRA/618 
 
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  8. Relevant documents:  Brazilian Official Journal (Diário Oficial da União), 29 January 2015; 
Section 1, p. 69, Draft Resolution (Consult a Pública) Nº 05, 28 January 2015, 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: 6 March 2015 
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://portal.anvisa.gov.br  
http://portal.anvisa.gov.br/wps/wcm/conne ct/e87c3b80471d65db9a589b41cdd33a01/Consu
lta+P%C3%BAblica+n%C2%B0+05+GGREG.pdf?MOD=AJPERES