G/TBT/N/BRA/603  
 
13 August 2014  
(14-4694)  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: 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): Substances under 
special control. 
5. Title, number of pages and langua ge(s) of the notified document: Draft Resolution nº 
66, 6 August 2014, that updates the Annex I, List of Narcotics, Psychotropic Drugs, 
Precursors and Other Su bstances under Special Control, of Ordinance SVS/MS 344/98. (25 
pages, in Portuguese).  
6. Description of content: Draft Resolution nº 66, 6 August 2014, that updates the Annex I, 
List of Narcotics, Psychotropic Drugs, Precursors and Other Substances under Special Control, of Ordinance SVS/MS 344/98. This draft resolution establishes the following modifications: 
Inclusion: 
1.1. List "C1": Benzydamine 1.2. Inclusion of the addendum 7 in the list “C1” 
According to this draft resolution, it is prohibited to import, manufacture, manipulate, 
acquire, sale and dispense systemic use BENZYDAMINE based medicines. BENZYDAMINE 
based medicines which pharmaceutical forms are extemporaneous preparation powder, 
gynaecological solution, spray, drops, mouthw ash, toothpaste and gel are not subject to 
special control. 
The establishments that use the substance BENZYDAMINE will have a period of 30 days 
from the date of publication of this Resolution for adaptation to the requirements of the 
Ordinances SVS/MS 344/98 and 6/99. However, to obtain the Special Authorization this 
period will be of 180 days.  
7. Objective and rationale, including the nature of urgent problems where applicable: 
Protection of Human health or Safety G/TBT/N/BRA/603 
 
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  8. Relevant documents:  Brazilian Official Journal (Diário Oficial da União), August 7th 
   2014; Section 1, p. 40, Draft Resolution (Consulta Pública) number 66, August 6th 2014, 
issued by Brazilian Health Surveillance Ag ency – 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: 12 September 2014 
11. Texts available from: National enquiry point [  ] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:   
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: www.anvisa.gov.br 
 http://portal.anvisa.gov.b r/wps/wcm/connect/685421804503e6349e7cfeef4ebdb6ee/Consult
a+P%C3%BAblica+n+66+GFARM.pdf?MOD=AJPERES