Egyptian Drug Authority

 
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Naming Committee

  How to Check a Product Name (New)

About Us

Naming & Labeling Committee is responsible for the following:

1) Revising & selection of the trade names of the new pharmaceutical Products applied for registration (Human drugs, Dietary supplements, Biologicals, Veterinary products) using naming lists applied by the company according to the approved Naming SOPs

2) Revising trade names for pharmaceutical products applied for export

3) Revising & selection of the trade names of the new pharmaceutical Products applied for registration (Human drugs, Dietary supplements, Biologicals, Veterinary products) using naming lists applied by the company according to the approved labeling SOPs

4) Revision of the variation requests for the trade names &outer Packs of the registered products. approved

How to submit


a) Steps for New Human Drugs Names selection:

1. Company will apply the first naming list within the application of the new human drug registration to the Human Drug Reception pharmacist.
(N.B.:If your newly applied Product is a line extension for an another previously approved product, please refer to your previous Product).
2. Naming & Labeling committee receives new first naming lists from Human Drug Reception Department internally.
3. The list is checked and revised to select the appropriate new trade name according to the approved Naming SOPs.
4. If a new name is selected, the name approval letter will be released in date with the Box approval.
5. If the list is rejected, the refusal letter will be released in date with the Box approval and the company should apply the second naming list to the Naming reception pharmacist as soon as possible.
6. Second lists revision result should be available for companies within 24 hours.

b) Steps for Layouts approval:

1. Within the Product Hard File Content , The Company should apply 5 Proposed colored copies of the layout attached in the hard file of the product to the Reception pharmacist of each Department.
2. Under supervision of Naming & labeling committee, Layouts is checked and revised according to the approved labeling SOPs.
3. Within the Hard file assessment report, Comments would be sent to company by email attached with a colored scanned layout showing these comments.
4. Company will apply 5 colored copies of the layout after performing requirements to the Reception pharmacist of each Department.
5. Layouts for approval will be sent to the naming & labeling committee internally where it will be revised and approved.

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Contacts



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