How to Register Foreign Veterinary Products in the Middle East
Contents Overview
General Requirements for Veterinary Product Registration in the Middle East
Veterinary product registration process in the Middle East for imported treatments generally follows strict regulations to ensure safety, efficacy, and quality. Local agents (distributors) who are looking to import veterinary products to their markets must work with a reliable supplier and manufacturer that can understand the local requirements to ensure a smooth and quick registration process.
Registration process normally takes a long time, AdvaCare’s streamlined registration process ensures site and product registration to go as smoothly as possible with the distributors. While the specific requirements can vary by country, there are some common steps and documents that are typically required across the region:
Steps for Manufacturing Site Registration
In most Middle East countries, manufacturing site registration is required first prior to the product registration process. This is to ensure that the registering company meets GMP standards and has proper licenses to conduct business in the country, or proper documentation to authorize a local representative. Manufacturing site registration process in the Middle East typically includes:
- Submission of application forms and administrative documents.
- Submission of manufacturing site certifications: This serves as proof that the manufacturing site meets required GMP standards.
- Document authentication: Documents issued from a foreign country often need to be authenticated, either through notarization or legalization at the relevant consulate, to prove their authenticity and legal standing in the host country.
- Submission of technical documents: These include the Site Master File (SMF) and other technical details necessary for evaluation.
- Site inspection: In some countries, the local regulatory authority (e.g., Ministry of Health or FDA equivalent) may conduct a physical inspection of the manufacturing facility to ensure compliance with local standards.
After manufacturing site registration is completed, the second process of product registration can then be started.
Steps for Product Registration
Product registration process for veterinary products in the Middle East involves submitting detailed documentation to ensure that the products meet the required safety, efficacy, and quality standards for import and distribution. This process varies slightly between countries but generally follows a similar set of steps.
- Dossier Submission: A comprehensive dossier containing product composition, manufacturing process details, quality analysis and test methods, clinical efficacy, stability data, and other reports must be submitted.
- Product/Ingredients Certificate Submission: In addition to the technical documentation, certain certificates related to the finished product or raw materials may need to be submitted. These can include Free Sale Certificates (FSCs) and Certificates of Pharmaceutical Product (COPPs) to demonstrate that the product is registered and approved for sale in its country of origin or other markets. Additional certificates may be required to confirm compliance with specific regulations, such as material declarations to meet Non-GMO or Halal standards or ensure the safety of ingredients.
- Product Labeling and Packaging: Submission of product labeling and packaging information is required to ensure that they comply with local regulations. This includes label claims, language requirements, and batch release requirements.
- Sample Submission: In many cases, samples of the product must be submitted for laboratory testing by the local regulatory authorities. These tests ensure the product matches the specifications outlined in the dossier and complies with the standards for quality and efficacy.
- Approval & Issuance of Registration Certificate: Once all required documents have been submitted and approved, and any necessary inspections or tests are completed, the regulatory authority will issue a product registration certificate. This certificate allows the distributor to import, market, and sell the product in the country.
With the general overview of the manufacturing site and product registration process outlined, the following sections will provide a detailed examination of the specific requirements for each Middle Eastern country.
Registration Requirements for Veterinary Products in Saudi Arabia
1. Where to Apply for Veterinary Site and Product Registration?
The Saudi Food and Drug Authority (SFDA) is the regulatory body responsible for veterinary product registration in Saudi Arabia. Applications for both site and product registration must be submitted to the SFDA. The process is primarily online through the SFDA’s dedicated electronic platform. You will need to create an account and submit documents via this portal. Physical or in-person submissions are generally not required unless otherwise stated by the SFDA.
2. What is the Estimated Cost for Registration?
- Site Registration: Costs can vary depending on document authentication and the need for site inspections, particularly if the facility is outside of Saudi Arabia. The total cost for site registration can range from $10,000 to $20,000.
- Product Registration: The cost for product registration generally includes submission fee and product testing. Estimated costs for product registration range from $2,000-5,000, depending on the product's complexity and testing requirements.
3. What Happens If Proper Documentation is Not Submitted?
If improper or incomplete documentation is submitted, the SFDA will issue a request for additional information or clarification. Failure to address these issues promptly can lead to delays, or worse, rejection of the application.
- Consequences of Failure: If proper documentation is not submitted within the provided timeline, the registration process will be halted, and the applicant will need to reapply. This can extend the registration timeline significantly and incur additional costs.
Learn more about how becoming an AdvaCare Veterinary distributor ensures smoother and more efficient registration processes by meeting local regulatory requirements down below.
Registration Requirements for Veterinary Products in the UAE
1. Where to Apply for Veterinary Site and Product Registration?
Veterinary site and product registrations in the UAE are managed by the Ministry of Climate Change and Environment (MOCCAE). Applications must be submitted through MOCCAE’s online portal, where documents can be uploaded and reviewed electronically. In-person submissions are generally not required unless specifically requested.
2. What is the Estimated Cost for Registration?
- Site Registration: Depending on document requirements and potential inspections, the cost for registering a manufacturing site typically ranges between $5,000 and $10,000.
- Product Registration: The cost for product registration, including dossier review and potential laboratory testing, can vary between $2,000 to $5,000 per product.
3. What Happens If Proper Documentation is Not Submitted?
If incomplete or incorrect documentation is submitted, MOCCAE will request clarifications or additional information. Failing to provide the required documents within the specified timeframe could lead to delays or even rejection of the application. Rejections require a reapplication, which could prolong the registration process and incur additional costs.
Partnering with AdvaCare Pharma ensures smoother and more efficient registration processes by meeting local regulatory requirements down below.
Registration Requirements for Veterinary Products in Jordan
1. Where to Apply for Veterinary Site and Product Registration?
In Jordan, veterinary site and product registrations are managed by the Ministry of Agriculture (MOA). Applications for both site and product registration must be submitted to the Veterinary Products Division of the MOA. The application process is handled primarily through the Ministry’s official platform, where documentation can be submitted electronically.
2. What is the Estimated Cost for Registration?
The estimated cost for registering veterinary products in Jordan generally includes:- Site Registration: The cost for registering a manufacturing site, including document review and potential site inspections, is typically around $3,000 to $6,000.
- Product Registration: The cost for veterinary product registration, including dossier submission, review, and testing, can range between $2,000 and $4,000 per product.
3. What Happens If Proper Documentation is Not Submitted?
If the proper documentation is incomplete or not submitted, the Ministry of Agriculture will request the necessary corrections or additional information. Failure to provide this documentation within the specified time may result in delays or rejection of the application. If rejected, the applicant must reapply, which can further delay the process and incur additional fees.
Discover how partnering with AdvaCare Pharma simplifies the registration process by ensuring compliance with local regulatory requirements.
Simplifying the Registration Process with AdvaCare Pharma
Going through the complex process of registering foreign veterinary products in the Middle East requires a deep understanding of each country’s specific regulations, from dossier submission to local testing and post-market surveillance. Partnering with an experienced company like AdvaCare Pharma, which has extensive expertise in the region, ensures a smoother and more efficient registration process. With our insights and tailored services, we help you overcome regulatory challenges and successfully register your veterinary products across the Middle East.
It is important for distributors to work with manufacturers that are able to provide utmost technical support in this highly complex process. The estimated timeline for registration from site registration to product registration completion can be broken down as follows:
Manufacturing Site Registration
- Preparation and Submission of Documents: This includes submitting the Site Master File (SMF), GMP certificates, and any other technical documentation. It also involves authentication of foreign documents, such as Free Sale Certificates (FSC) or Certificates of Pharmaceutical Product (CPP).
Estimated Time: 1-3 months, depending on the readiness of the documents and the authentication process. - GMP Review and Site Inspection: After submission, the responsible authority may review the documents and conduct a site inspection if necessary. If the manufacturing facility is outside the country, this could add additional time for scheduling and travel.
Estimated Time: 2-6 months, depending on whether a physical site inspection is required and the complexity of the review. - Approval of Manufacturing Site: Once the responsible authority is satisfied with the documents and the inspection (if required), they will approve the site.
Estimated Time: 1-2 months for final approval.
How Do We Make Site Registration Easy?
- Streamlined Document Preparation and Authentication AdvaCare Pharma ensures that all site documents, including the Site Master File (SMF) and GMP certificates, are constantly up-to-date and ready for submission. This allows for a fast start in the site registration process. We prioritize the authentication process and, with the distributor's confirmation, make sure that the correct documents are legalized right away, minimizing delays and avoiding unnecessary costs due to the wrong documents being processed.
- Experienced in GMP Review and Site Inspections AdvaCare Pharma has successfully passed multiple GMP reviews and site inspections across the region, meeting the high standards expected by local authorities. Our production facilities maintain stringent quality control measures, ensuring compliance with regulatory requirements. From facilitating visa applications to guiding inspectors during site visits, AdvaCare Pharma efficiently manages the entire inspection process, providing a seamless experience for distributors and inspectors alike.
Learn more about our 7-Step Registration Process >>
Product Registration
- Dossier Submission: Once the site is registered, the next step is to submit the product dossier, which includes product composition, manufacturing process details, clinical efficacy, stability data, and other technical information.
Estimated Time: 1-2 months for preparation and submission of the dossier. - Review of Product Dossier: After submission, the Responsible authority will review the product dossier. They may request additional documents or clarifications during this period.
Estimated Time: 4-6 months, depending on the complexity of the product and the completeness of the dossier. - Sample Submission and Testing: In parallel with the dossier review, product samples are often submitted for laboratory testing. These tests ensure that the product matches the specifications outlined in the dossier.
Estimated Time: 1-3 months, depending on the test results and whether additional testing is required. - Approval and Issuance of Registration Certificate: Once the dossier is approved and the product passes the laboratory tests, the responsible authority will issue the product registration certificate.
Estimated Time: 1-2 months for the final approval and issuance of the registration certificate.
This timeline assumes no major delays or issues with document authentication, site inspections, or product testing. However, factors such as incomplete submissions, failed inspections, or rejected samples could extend the timeline.
Why Are We Product Registration Experts?
- Comprehensive and High-Quality Dossier Submission At AdvaCare Pharma, we prioritize quality and compliance in every dossier submission. Our experienced technical team ensures that each dossier is tailored to meet the specific requirements of the country where the registration is being filed. By thoroughly gathering all necessary internal and external references before starting the registration process, we minimize the chances of additional requests or rejections from local authorities, making the review process smoother and faster.
- Custom Packaging and Sample Quality Packaging is a critical element in product registration, and AdvaCare Pharma goes the extra mile to ensure it meets local standards. We collaborate closely with our distributors to design and produce packaging artwork that complies with local regulations. Our samples are manufactured per registration to ensure the highest quality, which aligns with each country’s stringent testing and evaluation requirements. This approach guarantees that our products meet all local standards, facilitating a successful and efficient registration process.
Watch a Video about how we handle Product Registration efficiently >>
AdvaCare Pharma understands the complexities of navigating the rigorous registration requirements for veterinary products. With several products already registered in the GCC region and 65+ countries worldwide, we provide a streamlined and reliable path to market success. Our commitment to regulatory excellence, combined with tailored support and packaging solutions, ensures that your registration process is smooth and efficient.
Join our global network of trusted distributors today. As an AdvaCare Pharma partner, distributors will benefit from comprehensive regulatory and technical assistance, ensuring faster market access for high-quality, affordable products. We also offer exclusive distributor perks, including comprehensive marketing support, product training, and sales resources to help grow your business. With a commitment to strong partnerships, we are dedicated to your long-term success. Visit our website and apply for distributorship to gain a competitive edge in your region.
References: SFDA 2015 "Veterinary Products Act and Regulation in GCC" MOCCAE 2024 "Registration of veterinary products manufacturing company" MOCCAE 2024 "Registration of veterinary product" MOA 2024 "Category"
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