How to Register Foreign Veterinary Products in Egypt

Egypt’s veterinary product registration process is divided into four distinct categories depending on the type of veterinary product, each having a different registration process. These include:

• Feed Additives or Nutritional Supplements
• Veterinary Medicines
• Veterinary Disinfectants
• Veterinary Vaccines

Each classification follows a specific registration pathway, from dossier submission to sample testing and final approval, tailored to the product type and its intended use. The registration process of all veterinary products is handled under the Egyptian Drug Authority (EDA).

The registration process for feed additives and supplements in Egypt is overseen by the Ministry of Agriculture (MOA), specifically through the Central Laboratory for Animal Feed and Additives, although registration process is still handled through the Egyptian Drug Authority (EDA).
While it is under the same guideline and general process as with Veterinary Pharmaceuticals, it often involves fewer technical document requirements. The detailed guideline of veterinary feed additive or nutritional supplements registration in Egypt can be found here:

• Veterinary Feed/Nutritional Supplement Products Registration in Egypt

The process ensures that all products meet the nutritional, safety, and quality standards for animal consumption.
1. Dossier Submission:
The submission process begins with presenting a dossier containing the following:

• Product Composition: Detailed information about the ingredients, including active components, excipients, and their sources.
• Manufacturing Process: A comprehensive description of how the feed additive or supplement is produced, including quality control points and safety protocols.
• Nutritional Efficacy Data: Documentation supporting the efficacy of the product in improving animal health or nutrition.
• Safety Data: Studies and analyses proving the product’s safety for animal consumption, including any potential side effects or toxicity levels.

Certificates:

• Free Sale Certificate (FSC): Verifying the product is legally sold in its country of origin.
• Non-GMO Certificate: If applicable, this certificate ensures that the product does not contain genetically modified organisms.

2. Sample Submission and Testing:
Samples of the product must be submitted to the Central Laboratory for Animal Feed and Additives for thorough testing. The laboratory tests aim to verify that the product complies with Egyptian standards for animal feed, ensuring that it is safe and beneficial for animal consumption.
Tests conducted may include:

• Nutritional Analysis: Ensuring the product provides the claimed nutritional benefits.
• Contaminant Testing: Checking for the presence of harmful substances such as heavy metals, pesticides, or harmful microbial contaminants.

3. Packaging and Labeling Compliance:
The MOA requires that all feed additives and supplements meet strict packaging and labeling standards. Labels must include:

• Composition Details: Listing all ingredients and their quantities.
• Instructions for Use: Clear guidance on how the product should be administered or mixed with animal feed.
• Safety Warnings: Any precautions or risks associated with the product's use.
• Nutritional Claims: The claims made regarding the benefits of the product must be substantiated with scientific evidence.

4. Approval and Issuance of Registration Certificate:

• Upon successful testing and dossier review, the MOA will issue a Registration Certificate for the feed additive or supplement, permitting its sale and distribution in Egypt.
• This certificate is typically valid for 5 to 10 years, depending on the type of product, after which renewal is required.

Estimated Timeline: The process generally takes 6 to 9 months, depending on the readiness of the dossier and the time required for laboratory testing.

The detailed guideline of veterinary feed additive or nutritional supplements registration in Egypt can be found here:

• Veterinary Medicine Products Registration in Egypt

The registration of veterinary medicines in Egypt follows a structured and multi-step process aimed at ensuring product safety, efficacy, and compliance with Good Manufacturing Practices (GMP). Below are the detailed steps:
1. Pre-Registration Requirements:

• The applicant (typically a manufacturer or local distributor) must have a registered account with the Egyptian Drug Authority (EDA).
• All manufacturing sites must be GMP-compliant and have the appropriate documentation to prove their compliance.

2. Dossier Submission:

• Site Master File (SMF): This document provides comprehensive information about the manufacturing facility, including personnel, equipment, layout, and quality control measures.
• Good Manufacturing Practice (GMP) Certificate: A valid certificate issued by a recognized authority confirming the manufacturing site meets GMP standards.
• Product Information: A detailed description of the product’s composition, active ingredients, excipients, and method of manufacture. This should also include Pharmacological Data, Stability Data, Clinical Efficacy, Toxicity Studies, and Quality Control Protocols.
• Certificates such as Free Sale Certificate (FSC) and Certificate of Pharmaceutical Product (CPP).

3. Scientific and Administrative Review:

• The dossier is reviewed by the scientific committee of the EDA. They will assess the product's safety, efficacy, quality control measures, and compliance with local and international standards.
• The process may include requests for additional information or clarification, depending on the product's complexity and dossier completeness.

4. Sample Testing and Analysis:

• Product samples must be submitted to an EDA-approved laboratory for analysis. The laboratory testing focuses on ensuring the product meets the specifications provided in the dossier, including the potency, purity, and stability of the product.
• Results from this analysis will contribute to the final decision on product approval.

5. Approval and Issuance of Registration Certificate:

• If the EDA is satisfied with the dossier and laboratory test results, they will issue a Veterinary Product Registration Certificate, allowing the product to be marketed and distributed in Egypt.
• The registration certificate is typically valid for 10 years, after which renewal is required.

Estimated Timeline: The entire process typically takes between 6 to 12 months, depending on the product’s complexity and the completeness of the initial dossier submission.

The registration of disinfectants intended for veterinary or general use is managed by the Egyptian Drug Authority (EDA), and overseen by the General Administration of Biocides Registration under the Central Administration of Pharmaceutical Products (CAPP).
This process ensures that all disinfectants meet safety and efficacy standards for animal and human health.The detailed guideline of veterinary disinfectant registration in Egypt can be found here:

• Veterinary Disinfectant Products Registration in Egypt

1. Dossier Submission:
Required documents include:

• Product Composition: Detailed formula and active ingredients.
• Manufacturing Process: Full description of the production process.

The registration file must be uploaded to the EDA's online platform, accompanied by the required fees and documentation.

2. Labeling and Packaging:

Labels must comply with Egyptian standards, specifying usage instructions, safety warnings, and ingredient lists in Arabic and any other required languages.

3. Sample Testing:

Samples of the disinfectant must be submitted for laboratory testing to ensure they meet safety and efficacy standards. Disinfectants must prove effectiveness against targeted microorganisms and meet all regulatory requirements for veterinary environments.

4. Approval:

The application is reviewed by a specialized committee. Upon successful evaluation, the product is granted a Registration License, valid for 10 years.

5. Preliminary Approval for New Products:

A preliminary approval is issued for new products, which allows manufacturers to produce and test batches locally under controlled conditions. For imported products, stability studies and product samples must be submitted for verification.

6. Renewal and Extension:

Products must be re-registered before the 10-year expiration.Re-registration is required every 10 years, with additional stability data and potential sample testing during re-registration. If additional time is needed to complete requirements, an extension can be granted.