Documents Required for Registrations
 

Needed document for registration Ministry Of Agriculutre

1. Certificate of composition .
2. Certificate of analysis .
3. Methods of analysis .

to be legalized from Egyptian Embassy " you can attach
altogrther with one pin and make the certificate of composition
the last one to have all stamps and seals "
Authorication letter ; legalized

Needed document for registration Ministry Of Health

1. a covering letter indicating the documents contained in the file.
2. An application from registration duly filled in and signed.
3. certificate of origin and free sale issued from the ministry of
health in the country of origin, legalized by the Egyptian
Embassy of consulate in that country, including clearly :

a- Name and address of the manufacturer
b- Name and strength of the product, name & quality of active
ingredients
c- That the product is freely sold in its country of origin under
the same name and composition
4. Five copies of the complete formula, quantitative, quantitative of
active and inactive ingredients , coloting matters ,etc.
5. Five copies of the method of analysis and assay of the active
ingredients in the finished product in detail, in English
6. Seven to ten original samples for analysis.
7. Certificate of analysis in 2 copies, from the manufacturing firm,
in which is also clarified the same batch number of the samples
submitted for analysis. It should also state the dates of
preparation & expiration of the product, if any.
8. In case of antibiotics, another certificate of analysis for each raw
martial of antibiotic used , must be submitted. This should state
the dates of preparation and expiration of the raw material.

9. a- Five original outer labels.
b- Five original inner labels.
c- Five original inner pamphlets

10. A full scientific file for the new product including formula,
pharmacological, toxicological, clinical studies , etc.... an
stability data.

11. Agency Agreement of authorization or Registration
This should be granted to an Egyptian citizen or a scientific office
in Egypt, and must be legalized by the Egyptian Embassy or
consulate in the country of Origin.

12. A governmental postal order for the fee of five Egyptian Pounds
to the order of @ The General Administration of Pharmacy,
ministry of Health, A.R.R

13. Prices:
the following prices should be indicated for the product in its
different package:
i. Ex. factory price
ii. Public price in the country of Origin
iii. F.O.B price
iv. Expected public price in Egypt

13. A subsidiary file containing a copy of each document submitted
in the original file.

N.B.: For pharmacopeia preparation, all the above documents must
be submitted except those under Nos.2,4 and 10.