Egyptian Drug Authority

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18/11/2009 :  New Procedure for Submission of Stability Studies

As part of registration and re-registration procedure, a new system for submission of stability studies is implemented. Taking effect on November 15, 2009, the new system includes significant changes in the steps of submission of stability study files as follows:

  • Send a stability study submission request form as an attachment to following e-mail
  • You will receive a reply message from CAPA (within three working days) informing you with the date and time to present your file at CAPA.
Important Remarks:
  • If the company representative was late 15 minutes after the pre-determined appointment time, the submission meeting will be cancelled and the company should go back and start the submission request again following the same procedure described above.
  • Each company (applicant) can submit up to maximum of 6 stability studies per month. More than one stability file can be submitted at the same meeting.

  Stability study submission request form