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01/08/2009 :  Guidelines for Minister Decree 296


The New Guidelines for Minister Decree 296 that illustrate how to take an appointment to submit a New Human Drug Registration Request, and the will be activated starting from 01/08/2009
  - CAPA will send an email to confirm the agreed meeting (date and time) of application submission within 3 working days.
  - Maximum number of application that could be submitted by the local factory is four applications per month at four different meetings, while the imported and toll company could submit only two applications per month at two different meetings {except the different concentrations of the same dosage form (each in a separated application); they might be submitted at the same meeting}.
  - CAPA will receive 10 applications per day (application/company), four days per week (no submission meeting on Thursday)
  - The application may be refused for reasons other than the box is closed at the present time.
  - If the company Representative was late 15minute after the pre -determined appointment, the meeting will be cancelled and the company have to ask for another appointment.
  - Accepting the application doesn’t guarantee a market authorization, only when the company receives a final authorization.
  - Application file might be rejected at any stage and the reason of rejection will be given to the applicant.
  - Make sure that your Company Profile (submitted once) had been received by CAPA before submitting the application.

  SOPs for Pre submission
  Application Form
  Company Profile For Factories
  Company Profile For Toll Pharmaceutical Manufacturer
  Company Profile For Agents
  Company Profile For Scientific Office