National  Health  Surveillance  Agency  -­‐  ANVISA  
General  Management  of  Technology  of  Products  for  Health  -­‐  GGTPS  
TECHNICAL  NOTICE  No  001/2010/GGTPS/ANVISA  
 
1. Subject:  Requirement  of  Certification  of  Compliance  with  Good  Manufacturing  
Practices  and  Control,  aiming  registration  and  renewal  of  registers  of  Products  
for  Health,  as  provided  in  the  RDC  No  25/2009  
 
The   General   Management   of   Technology   on   Products   for   health   clarifies   for   productive  
sector   the   procedures   adopted   for   the   evaluation   of   submissions   for   registration,   renewal  
of   registers   and   changes   in   the   manufacturer,   related   to   the   Good   Manufacturing   and  
Control  Practices  Certificates  (GMP):  
 
1.  Submissions  for  registration  of  Products  for  health:  
1.1.  Process  submitted  before  the  validity  of  RDC  No  25/2009  will  be  analyzed  following  
the  criteria  adopted  until  this  date  
1.2.  Process  submitted  after  the  validity  of  RDC  No  25/2009  (from  05/22/2010):  
1.2.1.  Must  submit  GMP  certificate.  The  absence  of  this  certificate  will  result  in  summary  
rejection,  as  provided  in  Article  2,  section  VII,  paragraph  2,  of  RDC  204/2005  
1.2.2.   In   cases   where   the   GMP   certification   has   been   requested   until   05/21/2010,   the  
company  may  submit  with  the  registration  process  a  copy  of  the  proof  of  submission   of  
the   request   for   GMP   audit.   We   emphasize   that   the   protocol   does   not   replace   the  
Certificate  of  GMP.  After  analysis  of  the  registration,  the  company  will  be  notified  by  fax  
about  the  conclusion  of  the  technical  analysis,  and  the  publication  of  the  decision  in  the  
Official   Gazette   will   occur   after   the   publication   of   the   Good   Manufacturing   Practices  
Certificate.  
1.2.3.  In  cases  where  the  certification  has  been  requested  after  05/21/2010,  the  company  
must  submit  the  GMP  Certificate.  It  will  not  be  accepted  copy  of  the  proof  of  submission  
for   the   GMP   inspection   request.   The   absence   of   this   certificate   will   result   in   summary  
rejection,  as  provided  in  Article  2,  section  VII,  paragraph  2,  of  RDC  204/2005  
 
2.  Submissions  for  renewal  of  registers  of  Products  for  Health:  
2.1.  The  processes  submitted  before  the  validity  of  the  RDC  No  25/2009  will  be  analyzed  
following  the  criteria  previously  adopted.  
2.2.   The   processes   submitted   after   the   validity   of   RDC   No   25/2009   should   present   the  
GMP  Certificate.  
2.2.1.   If   the   certification   has   been   requested,   the   company   must   submit   along   with   all  
other  documents  to  the  renewal  of  the  products  register,  the  proof  of  the  submission  of  
the  GMP  certification  request.  
 
Brasília,  October  5,  2010.  
 
Flowchart  for  the  requirement  of  GMP  
 
1.  Submissions  for  the  RENEWAL  of  Health  Products:  
 
 
 
  Renewal  request  
 
 
 
Does  the   Does  the   The  manufacturer  
  manufacturer  have   No   manufacturer  have  
No  
requested  the  GMP  
No  
Request  rejected  
  GMP  Certificate?   GMP  request?   Certificate?  
 
  Yes   Yes  

  Under  analysis   Yes   Submit  the  

  GMP   request  

 
  Under  analysis  
 
 
 
2.  Submissions  for  the  RENEWAL  of  Health  Products:  
 
 
Registration  request  

Does  the   Does  the  

manufacturer  have  
No   No   Request  rejected  
manufacturer  have  
GMP  Certificate?   GMP  request?  

Yes  
Yes  

Under  analysis  
Does  the  
Yes  
manufacturer  have   Fax  
Under  analysis  
GMP  request?  

No  

Request  rejected