 WORLD TRADE  
ORGANIZATION  G/TBT/N/BRA/111/Add.1 
30 April 2004 
 (04-1931) 
Committee on Technical Barriers to Trade Original:  English 
  
NOTIFICATION  
 
Addendum
 
  
 The following communication, dated 27 April 2004,  is being circulated at the request of the 
Delegation of Brazil
. 
  
_______________  
 
  The draft technical regulation notified unde r G/TBT/N/BRA/111, on mandatory technical 
requirements for phytotherapic drugs, has entere d into force through Resolution RDC number 48, 
dated 16 March 2004, issued by the Brazilian Sanitary Surveillance Agency - Anvisa.  
  According to the above-mentioned Resolution, within 360 days, all quality control tests must be undertaken in one laboratory of the Brazilian Network of Analytical Laboratories - REBLAS.   
 Phytotherapic drugs registered before 31 January  1995 must present register requirements in 
their first revalidation register application made w ithin 360 days following the date of adoption of the 
above-mentioned resolution.  Exemption is made for drugs registered as traditional phytotherapic 
drugs.   
 The full text of the document can be downloaded at:  
  http://e-legis.bvs.br/leis ref/public/showAct.php?id=10230
 (available in Portuguese)  
 
 Brazil also lists the following guides which can be consulted in order to comply with the 
requirements established by Resolution-RDC number 48: 
 
- List on bibliographical references for safety and efficacy assessment of 
phytotherapic drugs – Resolution RE number 88, dated 16 March 2004,:  
http://e-legis.bvs.br/leis ref/public/showAct.php?id=10240 
 
- List on simplified registry procedures for phytotherapic drugs – Resolution RE 
number 89 dated 16 March 2004: http://e-legis.bvs.br/leis ref/public/showAct.php?id=10241 
 
- Guidelines for the execution of pre-clinical toxicity studies of phytotherapic 
drugs – Resolution RE number 90, dated 16 March  2004: 
  http://e-legis.bvs.br/le isref/public/showAct.php?id=10230 
 
- Guidelines for the execution of chang es, inclusions, notifications and post-
registration cancellation of phytotherap ic drugs – Resolution RE number 91, 
dated 16
 March 2004:  
http://e-legis.bvs.br/leis ref/public/showAct.php?id=10243 
 
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