Egyptian Drug Authority

 
Services > Registration > Drugs for Human Use

Drugs For Human Use

Any medicine should be registered at the Ministry of Health and given MOH Registration Number before it can be traded or given to people. CAPA is responsible for the re any medicines before it is traded in the Egyptian market. CAPA registration process starts by receiving Registration Submission Request via E-Mail as described in the following guidelines:

Guidelines for Submission of Registration Request

- Applicant sends an appointment request to appd@eda.mohp.gov.eg
- CAPA will send back an email to inform the applicant with the date and time for application submission within 3 working days.
- Maximum number of applications that could be submitted by one company (local manufacturer) is four applications per month at four different meetings. Import and toll companies could submit only two applications per month at two different meetings. Exception to this constraint is requests to register different concentrations of the same dosage form (each in a separated application). In this case, they might be submitted at the same meeting.
- CAPA will receive a maximum 10 applications per day (application/company), four days per week (no submission meetings 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 15 minute 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 the 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

  Registered Products (13 / 1 / 2010)
  Human Drug Registration
  New Request Inquiry Form 06-2014
  New SOPs for Request Inquiry (version 3) 06-2014
  Announcement for Request Inquiry 06-2014
  Sops of registration of sofobuvir + velpatsvir ( over the box)


Links

  (18/11/09) 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.

  Model for design of outer label.
  CAPA Head's Memos (63) for recalling Mucogel Suspension
  Guidelines for Minister Decree 296
  Erratum: Memo Number 14 for Barcoding of Packages
  New Minister Decree for Human Drug Registration
  EDA Publish A New proposed Bioequivalence guidelines
  Technical Committe Decision on 21/5/2009
  Allowed Imported Drug List
  SOPs For Naming(Update)
  10/12/1009 Products Name List

New Sops for submission of new request inquiry form acc. To min. dec. 425/2015

  Sops for Local Products
  Sops for Imported Products
  New Request Inquiry form
  List of References for submission of new request inquiry form


 
Back