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
• 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 firstname.lastname@example.org New important announcement for registration of dietery supplement
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 email@example.com
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.
Guidelines for registration of dietary supplement
Guidelines for CD