Egypt - Obtain a Certificate for Pharmaceutical Products

ProcedureEdit

'Apply In-Person:

To apply to obtain a Certificate for Pharmaceutical Products the applicant must first submit all the necessary documents required for the process to the Egyptian Health Authority.
Refer to the “Required Documents” section of this procedure to know more.
There must be evidence that the Drug products are manufactured according to Good Manufacturing Practice (GMP). In the case of imported drug products (from foreign country), the importer must submit evidence that they are licensed to manufacture the drug products for sale in the country of origin.
There must be evidence by the competent Health Authority, that the sale of the drug products does not constitute a contravention of the Drug laws of that country. I.e. Certificate of Pharmaceutical Product (COPP) that conforms to WHO format. The documents in respect of C1-3 shall be authenticated by the Mission in that country. In countries where no Egyptian Embassy or High Commission exists, any other Embassy or High Commission of any Commonwealth or North African countries can authenticate.
The applicant shall submit two (2) MA (Marketing Authorization) made out in accordance with the Agencies format. In Egypt Authorities may not be willing to accept the exported drugs until the final approval of a CPP has been submitted.
Safety and efficacy of the medicine is a requirement for a CPP certificate from the manufacturing source country, which does not provide additional assurances to the quality of the medicine.
Copy of current Annual License to Practice as a Pharmacist for the Superintendent Pharmacist issued by Pharmacists Authority should be submitted.
Copy of Current Certificate of Registration Retention of Premises is issued by Pharmacists Authority.
Comprehensive Certificate of analysis of the batch of drug products submitted for registration processing shall be submitted.
Annex 2 of the decree lists the generic groups/boxes and their forms. If a new pharmaceutical form is created, it can be added to Annex 2 after getting the approval of Technical Committee for Supervising Drugs at CAPA.
After all the documents have been submitted, a drug product cannot be marketed in Egypt, unless the exporter has produced a certificate of pharmaceutical product issued by Central Administration for Pharmaceutical Affairs General Inspection Department in Egypt. Egypt, accepts a Certificate Pharmaceutical Products at the time of Marketing Authorization. Current law requires that a CPP must be submitted from the country of origin.

Required DocumentsEdit

Covering letter indicating the documents contained in the file.
An application form for registration/duly filled in and signed.
Certificate or origin and free sale issued from the Ministry of Health in the country of origin, legalized by the Egyptian Embassy or Consulate in that country, including clearly:
- Name and address of the manufacturer.
- Name and strength of the product, name & quantity of active ingredients.
- That the product is freely sold in its country of origin under the same name and composition.
- Certificate of G M P for the industry manufacturing the Pharmaceutical qualities.
- Five copies of the complete formula, quantitative, qualitative of active and inactive ingredients, colouring matter, etc.
- Certificate of analysis in 2 copies, from the manufacturing firm, in which it 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.
List of countries where the product is registered & marketed.
Agency agreement of Authorization for Registration. This should be granted to an Egyptian citizen or a scientific office in Egypt, and must be legalized by the Egyptian Embassy of Consulate in the country of Origin.
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.E.
A Subsidiary file containing a copy of each document submitted in the original file.

Office Locations & ContactsEdit

Ministry of Health and Population
Address 3 Magless El Shaab st
Phone no. 27951821
Fax 27953966 - 27922904
E-mail [email protected]
Contact link

EligibilityEdit

All Drug manufacturing companies both local and international in Egypt are Eligible for this certificate

FeesEdit

Fees of Registration is 2000 L.E
Fees of Analysis is 3000 L.E
Medical stamps: 50 L.E.

ValidityEdit

The certificate of Pharmaceutical Products can be renewed after every 10 years.

Documents to UseEdit

Please attach documents that can be used by people. e.g. links

Sample DocumentsEdit

Please attach sample completed documents that would help other people.

Processing TimeEdit

The processing time is 3 months.

InstructionsEdit

The certificate of pharmaceutical product CPP or CoPP is a certificate issued in the format recommended by the Ministry of Health Egypt in Collaboration with World Health Organization (WHO), which establishes the status of the pharmaceutical product and of the applicant for this certificate in the exporting country.

Required InformationEdit

A list which displays the kind of information which is required to complete the procedure.
e.g.
1. Date of Birth.
2. City or Country of Birth.

Need for the DocumentEdit

This application lets you obtain a Certificate for Pharmaceutical Products.

Information which might helpEdit

Enter other information which might help.

External LinksEdit

Place some external links which might help.

OthersEdit

More information which might help people.