Egyptian Drug Authority

 
Services > Registration > Dietary Supplement

Registration Department of Dietary Supplements

The Department is responsible for registration of Dietary Supplements 
Including (Local – Toll– under license) according to:
•  All the Ministerial Decrees governing the registration of Dietary supplements in
   Egypt
•  The Regulations set by the Technical Committee for pharmaceutical products

Dietary supplement definition

A Dietary supplement is any product to be taken orally that improves the human diet in order to improve body functions and performance. The dietary supplement is not considered a drug or an alternative for food and is not used alone to treat, diagnose or prevent diseases.

Dietary supplement includes: 

   Vitamins   Fatty acids
   Minerals   Medicinal herbal, their extracts & oils
   Amino acids


Registration process of Dietary supplements proceeds as follows:

1- Filling an appointment request according to product's case of registration (New Registration, Re-registration with composition changes, Re-Registration without composition changes) then Sending via e-mail by the company requiring registration, The Company will send the appointment request to submit for soft file to app.dietary@eda.mohealth.gov.eg 

N.B The composition should be made on basis of Required Daily Allowance RDA for vitamins and minerals and the product composition template of Dietary supplements.

Maximum number of files to be submitted by a company is 2 files per week.

2- The Company will receive an e-mail from CAPA with the specified date for filesubmission.
3- On the Pre-determined appointment, the authorized person brings the soft file with a proposed name complying with the
   
Check list of Dietary supplement (Soft file) 
4- The file will be reviewed by the responsible pharmacist within 15 working days. 
5- After the 15 working Days the company will receive Notification letter about the     product. 
6- The Company should complete the required documents within a month time from receiving the Notification letter or the request
    will be cancelled. 
7- After the file is completed it will be applied for the scientific committee and then to the technical committee to take a decision
    about the product registration as a Dietary supplement.
8- Then the company will receive the committee decision (Approval or Refusal).
9- In case of Approval, the company will proceed in analyzing the product in NODCAR & pricing the product by the Pricing
    committee in CAPA & doing a stability study to be evaluated by the specialized committee of Stability.
10- After analysis, Pricing, Preparing the stability study file of the product, the company prepare hard file according to 
   
Check list for Dietary supplement (hard file) in order to get registration license of the product.
11- To submit for hard file the company requiring registration sends an appointment request via e-mail; The Company will send the
    appointment request to submit for hard file to 
dietary.info@eda.mohealth.gov.eg 
12- After receiving stability study committee report & completing the hard file, the hard file is submitted to the technical committee
    in order to get the final registration license in case of approval of the technical committee. 

New important announcement for registration of dietery supplement

  Request Sheet
  Application
  Guidelines for registration of dietary supplement
  Guidelines for CD


 
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