Egypt - Apply for Certifcate of Good Manufacturing Practice

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Procedure

Apply In-Person:

1. To apply for a Certificate of Good Manufacturing Practice there must be evidence by the competent Health Authority, that the sale of the product does not constitute a contravention of the food 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 Ethiopian 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.
2. The applicant shall submit two (2) dossiers made out in accordance with the Agency’s format.
3. Evidence of Trade Mark Approval for brand name from Ministry of Finance in Egypt should be submitted.
4. Copy of current Annual License to Practice as a Pharmacist for the Superintendent Pharmacist issued by Ethiopian Pharmacists Authority should be submitted.
5. Copy of Current Certificate of Registration Retention of Premises issued by Ethiopian Pharmacists Authority.
6. Comprehensive Certificate of analysis of the batch of food product submitted for registration processing shall be submitted.
7. After all the documents have been submitted, a drug product cannot be manufactured in Egypt, unless the factory is inspected and Certificate of Recognition is issued by Central Administration for Pharmaceutical Affairs General Inspection Department in Egypt. Then a certificate of Good manufacturing practice is issued.
   

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Required Documents

• Copy of permit and receipt (One copy).
• Dossier formatted
• Vetting Samples (Three of each product)
• Copy of Current Certificate of Registration Retention
• The documents in respect of C1-3.
• There must be evidence by the competent Health Authority.
• Comprehensive Certificate of analysis
  

Office Locations & Contacts

Ministry of Health
Central Administration for Pharmaceutical Affairs
General Inspection Department:
Tel.: +202 23684288 +202 23640368
Fax: +202 - 23684194
Contact link

Eligibility

All food manufacturers companies both local and international in Egypt are Eligible for this certificate.

Fees

One million LE (1,000,000:00) plus 5%.

Validity

5 years

Documents to Use

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Sample Documents

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Processing Time

4 months.

Related Videos

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Instructions

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e.g. The state office holds birth records since january 1908.

Required Information

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1. Date of Birth.
2. City or Country of Birth.

Need for the Document

This certificate help to ensure that regulatory compliance is followed while demonstrating knowledge of the importance of producing and trading safe, quality food.

Information which might help

• A Good Manufacturing Practices (GMP) certification scheme provides independent verification and certification that the basic manufacturing practices and prerequisites necessary for the implementation of an effective Hazard Analysis Critical Control Point (HACCP) food safety program are being followed.
  
• Good Manufacturing Practices are enforced in Egypt by SGS Egypt which is a world leader in third party certification and verification.
  

Other uses of the Document/Certificate

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e.g. Birth Certificate can be used as proof of identity.

External Links

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Others

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