Obtain a Certificate for Pharmaceutical Products in Giza (Egypt)

Introduction

The process of obtaining a certificate for pharmaceutical products in Giza involves several important steps to ensure compliance with local regulations and quality standards. This certification is crucial for pharmaceutical companies, as it confirms that their products meet the necessary criteria for safety, efficacy, and quality. In this article, we will outline the step-by-step process for obtaining a certificate for pharmaceutical products in Giza, Egypt.

Procedure

• Certificates of pharmaceutical products CPPs are enforced in Giza by the Ministry of Health Giza in Collaboration with World Health Organization to promote successful dialogue between the international pharmaceutical industry and Ministries of Health Egypt.
• The majority of Drug companies in Giza find that a legalized CPP from the source country is required at the time of Marketing Authorization (MA) application. However, the Egyptian Ministry will not grant final approval until a CPP has been received from Drug companies, a number are now willing to accept CPPs at the time of Marketing Authorization.
• They help to ensure that regulatory compliance is followed while demonstrating knowledge of the importance of producing and trading safe, quality Drugs.

These are the steps involved in applying for a certificate for Pharmaceutical products.

Step 1: Understand the Regulatory Framework

Before initiating the certification process, it is essential to familiarize yourself with the regulatory framework governing pharmaceutical products in Giza. Research and understand the relevant laws, regulations, and guidelines set by the Egyptian Drug Authority (EDA) and other applicable regulatory bodies. This step will help you grasp the specific requirements and expectations for obtaining a certificate.

Step 2: Prepare Documentation

To begin the certification process, gather and prepare the necessary documentation required by the regulatory authorities. Some common documents may include:

1. Product Information: Collect comprehensive information about the pharmaceutical product, including its composition, formulation, therapeutic indications, and dosage forms.
2. Manufacturing Process: Provide detailed documentation on the manufacturing process, including the facilities, equipment, and quality control measures employed.
3. Quality Control: Document the quality control procedures, specifications, and testing methods used to ensure the product's safety and quality.
4. Stability Data: Include stability studies that demonstrate the product's shelf life, storage conditions, and packaging integrity.
5. Clinical Data (if applicable): If the pharmaceutical product is new or requires clinical trials, compile the necessary clinical data, including study protocols, results, and safety profiles.

ALSO READ: Minimum Requirements to Establish a Pharmaceutical Manufacturing Plant

Ensure that all documentation is accurate, up-to-date, and follows the guidelines provided by the regulatory authorities.

Here you are required to present the necessary documents issued by the competent Health Authority in the country of manufacture (the exporting country). These documents differ in some aspects depending on the Drug product you want to register.

• Some of the documents include a contract manufacturing Agreement; 
• Manufacturing license and free sale certificate,
• Trademark registration, certificate of incorporation/business name, and many more. 
• a CPP Legalization perspective from the Exporting country is always required in Egypt.

Note: All the necessary documents must be found satisfactory before any other process can be carried out.

Step 3: Drug Production Evidence

There must be evidence that the Drug products are manufactured according to Good Manufacturing Practice (GMP). In the case of imported drug products (from a foreign country), The importer must submit evidence that they are licensed to manufacture the drug products for sale in the country of origin.

Step 4: Submit the Application

• Once the documentation is prepared, submit the application for the certificate to the appropriate regulatory authority. In Giza, the Egyptian Drug Authority (EDA) is responsible for evaluating and issuing pharmaceutical product certificates.
• Submit the application form along with the compiled documentation, paying attention to any specific formats or templates required. Ensure that all required fields are completed accurately, and any applicable fees are paid.

Step 5: Application Review

After submitting the application, the regulatory authority will review the documentation to ensure compliance with the regulatory requirements. The evaluation process may involve the following:

1. Review of Documentation: The regulatory authority will carefully assess the submitted documents, verifying their completeness, accuracy, and adherence to regulatory guidelines.
2. Site Inspection: In some cases, the regulatory authority may conduct an inspection of the manufacturing facilities to ensure compliance with good manufacturing practices (GMP) and other relevant standards.
3. Product Sampling and Testing: The authority may select samples of the pharmaceutical product for testing to verify its quality, safety, and efficacy.

Step 6: Compliance Verification

Based on the review process, the regulatory authority will assess whether the pharmaceutical product meets the necessary compliance standards. They will evaluate factors such as:

1. Quality Control: Review the quality control measures and test results to ensure the product consistently meets the required specifications.
2. Good Manufacturing Practices (GMP): Assess the manufacturing facilities and processes to ensure compliance with GMP guidelines.
3. Labeling and Packaging: Verify that the product labeling and packaging meet the specified requirements, including accurate information and proper storage instructions.

ALSO READ: Audit Checklist for the New Drug Approval Process by FDA

Step 7: Certificate Issuance

• If the pharmaceutical product successfully meets all the regulatory requirements, the regulatory authority will issue the certificate. This certificate serves as proof of compliance and enables the company to market and distribute pharmaceutical products in Giza.
• Upon receiving the certificate, ensure that it is displayed prominently and kept up-to-date, as it may be subject to periodic inspections and renewal requirements.

Step 8: Authenticated by Health Authority

• 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 the 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 country can authenticate.

Step 9: Marketing Authorization

The applicant shall submit two (2) MAs made out in accordance with the agency format. In Giza Authorities may not be willing to accept the exported drugs until the final approval of a CPP has been submitted.

Step 10: Safety and Efficacy of the Medicine

The 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.

Step 11: Annual License to Practice Pharmacist

Copy of the current Annual License to Practice as a Pharmacist for the Superintendent Pharmacist issued by the Ethiopian Pharmacists Authority should be submitted.

Step 12: Certificate of Registration

Copy of Current Certificate of Registration Retention of Premises issued by Ethiopian Pharmacists Authority.

Step 13: Comprehensive Certificate of Analysis

A comprehensive Certificate of analysis of the batch of drug products submitted for registration processing shall be submitted.

 

After all the documents have been submitted, a drug product can not be marketed in Egypt, unless the exporter has produced a produced certificate of pharmaceutical products issued by the 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.

Need for the Document

• The certificate of pharmaceutical product (CPP or CoPP) is a certificate issued in the format recommended by the Ministry of Health Giza in Collaboration with the World Health Organization (WHO), which establishes the status of the pharmaceutical product and of the applicant for this certificate in the exporting country. It is issued for a single product because manufacturing arrangements and approved information for different pharmaceutical forms and strengths can vary.
• Licensed pharmaceutical products (complying with the requirements of the marketing authorization) should be manufactured only by licensed manufacturers (holders of a manufacturing license) whose activities are regularly inspected by competent Egyptian authorities.

Conclusion

Obtaining a certificate for pharmaceutical products in Giza involves a comprehensive process that requires careful attention to regulatory guidelines, thorough documentation, and adherence to quality standards. By following these step-by-step procedures, pharmaceutical companies can ensure compliance with local regulations and demonstrate the safety, efficacy, and quality of their products in Giza, Egypt.

ALSO READ: Effective Dossier Management in Regulatory Affairs