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Nationwide Distribution

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Quick importation of vaccines

2

Importation of medicines

3

Fast Customer Service

4

Hire Now!

Distribute a Wide Range Of Pharmaceutical Products And Food Supplements To All Yemen Districts

logo Sabrah Pharma

Hire Now!

Distribute a Wide Range Of Pharmaceutical Products And Food Supplements To All Yemen Districts

Contact Us

Quick Links

Homepage

Click here to access

About Us

Click here to access

Our Services

Click here to access

Portfolio

Click here to access

Blog Archive

Click here to access

Contact Us

Click here to access

Business Model

Nationwide Distribution

1

Quick importation of vaccines

2

Importation of medicines

3

Fast Customer Service

4

Hire Now!

Distribute a Wide Range Of Pharmaceutical Products And Food Supplements To All Yemen Districts

logo Sabrah Pharma

Hire Now!

Distribute a Wide Range Of Pharmaceutical Products And Food Supplements To All Yemen Districts

Contact Us

Registration of products

Registration of products

Mastering Yemeni Pharmaceutical Registration of products : Unveiling a groundbreaking pharmaceutical product is a monumental feat. But for your life-saving medication to reach Yemeni patients, navigating the intricacies of product registration can feel like venturing through a labyrinth. Fear not, trailblazing pharmaceutical companies! This comprehensive guide, crafted by Sabrah Pharma, your trusted partner in the Yemeni market, will equip you with the knowledge and strategies to conquer the product registration maze.

We’ll delve into the essential steps, documentation requirements, and insider tips to ensure a smooth and successful registration process. From the initial consultation to post-marketing activities, Sabrah Pharma will be your guiding light, illuminating the path to bringing your medications to the Yemeni people.

Here’s what you’ll discover:

A step-by-step breakdown of the Yemeni pharmaceutical product registration process.
Crucial documents required for a successful registration.
Insider tips gleaned from Sabrah Pharma's years of experience.
The advantages of partnering with a local expert like Sabrah Pharma.

Embrace the challenge of Yemeni product registration with confidence. Let Sabrah Pharma be your guide!

Khalid Mohieldin

COO – Business Development Director

Registration of products

BEST SERVICES

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Our Servcies

Sabrah Pharma offers a comprehensive range of services to support our clients in Yemen and our global partners.

Guidance for registration of pharmaceutical products in Yemen

Yemen, a nation steeped in rich history and tradition, boasts a burgeoning pharmaceutical industry. As this sector flourishes, navigating the intricacies of product registration with Yemeni health authorities can feel like venturing through a labyrinth. But fear not, fellow pharmaceutical trailblazers! Sabrah Pharma, your trusted partner in the Yemeni market, is here to guide you through the process with clarity and expertise.

Understanding the Yemeni Regulatory Landscape

The Yemeni Ministry of Public Health and Population (MoPHP) spearheads pharmaceutical product registration. The ministry’s Pharmaceutical Control Department (PCD) meticulously evaluates submissions to ensure the safety, efficacy, and quality of medications entering the Yemeni market.

Here’s a breakdown of the key regulatory bodies involved:

The Yemeni Pharmaceutical Formulary Committee (YPFC):

This committee reviews and approves the inclusion of new medications in the Yemeni National Formulary.

The National Center for Drug Control (NCDC):

Responsible for post-marketing surveillance and monitoring of drug safety in Yemen.

By understanding these entities’ roles, you gain a clearer picture of the registration pathway.

Embarking on the Registration Journey: A Step-by-Step Guide

Now, let’s dissect the registration process itself. While seemingly complex, with Sabrah Pharma by your side, each step becomes a manageable milestone.

1. Initial Consultation:

Our journey begins with a comprehensive consultation. We’ll meticulously analyze your product details, including its technical specifications, therapeutic claims, and intended use. This initial assessment allows us to identify potential roadblocks and tailor a customized registration strategy.

2. Dossier Preparation:

The heart of the registration process lies in the dossier. This meticulously compiled document package serves as a comprehensive overview of your pharmaceutical product. Sabrah Pharma boasts a team of seasoned professionals adept at assembling robust dossiers that meet Yemeni regulatory standards. Our dossier will typically include:

  • The Common Technical Document (CTD): This internationally recognized document serves as the foundation of the dossier, encompassing detailed information on the product’s quality, safety, and efficacy.
  • Chemistry, Manufacturing, and Controls (CMC) Data: This section delves into the intricate details of your product’s manufacturing process, quality control procedures, and specifications.
  • Non-Clinical and Clinical Study Reports: These reports demonstrate the product’s safety and efficacy through pre-clinical and clinical trials.
  • Product Labeling and Packaging Information: This section ensures clear and compliant product labeling that adheres to Yemeni regulations.
3. Dossier Submission and Review:

Once the dossier is meticulously assembled and reviewed for accuracy, we’ll submit it electronically to the PCD. The PCD then embarks on a thorough review process, meticulously evaluating the dossier’s contents to ensure compliance with Yemeni regulations.

4. Communication and Potential Clarifications:

Communication is key! During the review process, the PCD may request additional information or clarifications regarding your dossier. Sabrah Pharma acts as your trusted liaison, facilitating seamless communication and ensuring timely responses to the authorities.

5. Inspection and Approval:

In some instances, the PCD may request on-site inspections of your manufacturing facilities. Sabrah Pharma, with its extensive experience, can guide you through this process to ensure a successful outcome.

Following a meticulous review, the PCD may grant full registration or request further modifications. Sabrah Pharma will remain by your side throughout this stage, advocating for your product and ensuring a successful registration.

6. Post-Marketing Activities:

Our commitment extends beyond registration. Sabrah Pharma can assist you with post-marketing activities like pharmacovigilance reporting and maintaining regulatory compliance throughout your product’s lifecycle in Yemen.

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Essential Documentation for Yemeni Pharmaceutical Product Registration

Here’s a glimpse into some of the crucial documents required for a successful registration:

  • Certificate of Pharmaceutical Product (CPP): Issued by the regulatory authority of the country where the product is manufactured.
  • Free Sale Certificate (FSC): Issued by the country of origin, confirming the product’s free marketing status.
  • Power of Attorney (POA): Authorizing Sabrah Pharma to represent you throughout the registration process.
  • Manufacturing Facility Licenses and GMP Certificates: Demonstrating your adherence to Good Manufacturing Practices (GMP).
  • Letters of Authorization: Granting Sabrah Pharma permission to act on your behalf during interactions with Yemeni authorities.

Remember: This list is not exhaustive, and specific requirements may vary depending on your product’s category.

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Insider Tips for a Smooth Yemeni Pharmaceutical Product Registration

While the outlined process provides a solid foundation, here are some insider tips gleaned from Sabrah Pharma’s years of experience navigating the Yemeni regulatory landscape:

  • Embrace Early Planning: Don’t underestimate the importance of starting the registration process well in advance. Regulatory timelines in Yemen can vary, so planning ahead allows for a smoother and more efficient process.
  • Maintain Meticulous Documentation: Regulatory compliance hinges on meticulous record-keeping. Ensure your documentation is well-organized, accurate, and up-to-date to avoid delays.
  • Partner with a Local Expert: The intricacies of the Yemeni regulatory landscape can be daunting for newcomers. Partnering with a seasoned local expert like Sabrah Pharma streamlines the process, leverages our established relationships, and ensures you navigate potential roadblocks with confidence.
  • Prioritize Quality and Transparency: Yemeni authorities prioritize the safety and efficacy of medications. Upholding the highest quality standards and maintaining transparent communication throughout the process fosters trust and facilitates a smoother registration journey.
  • Cultural Considerations: Building rapport and demonstrating respect for Yemeni culture goes a long way. Sabrah Pharma, with our deep understanding of the local landscape, can help you navigate these cultural nuances effectively.

By embracing these insider tips, you’ll be well-equipped to navigate the Yemeni pharmaceutical product registration process with greater confidence and efficiency.

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Advantages of Partnering with Sabrah Pharma for Yemeni Registration

Choosing the right partner is paramount to a successful Yemeni registration. Here’s why Sabrah Pharma stands out:

  • Unmatched Expertise: Our team boasts extensive experience navigating the intricacies of Yemeni pharmaceutical regulations. We possess a deep understanding of the Yemeni market and regulatory environment, ensuring a smooth and efficient registration process.
  • Streamlined Communication: We act as your trusted bridge, facilitating seamless communication with Yemeni authorities. This eliminates language barriers and ensures timely responses to inquiries or requests for clarification.
  • Cost-Effectiveness: Our efficient processes and established relationships help you navigate the registration process cost-effectively, saving you valuable time and resources.
  • Comprehensive Support: We go beyond simply submitting your dossier. We offer ongoing support throughout the entire registration process, from initial consultation to post-marketing activities.

Sabrah Pharma becomes an extension of your team, ensuring your pharmaceutical product reaches the Yemeni market efficiently and compliantly.

Your Gateway to the Yemeni Pharmaceutical Market

The Yemeni pharmaceutical market presents a promising opportunity to make a positive impact on people’s lives. By partnering with Sabrah Pharma, you gain a trusted advisor with the expertise and experience to navigate the Yemeni regulatory landscape with efficiency and success.

Let Sabrah Pharma be your gateway to the Yemeni market, ensuring your life-changing medications reach those who need them most. We look forward to collaborating with you and making a positive contribution to Yemeni healthcare.

Contact us today to embark on a successful Yemeni pharmaceutical product registration journey!

Exceptional Import Authorization Prior to Registration

Exceptional Pre-Registration Import Authorization for Pharmaceutical Products in Yemen: Can Sabrah Pharma Help?

In some cases, Yemeni authorities may grant an exceptional import authorization for a pharmaceutical product prior to full registration. This authorization allows for a limited quantity of the product.

While Sabrah Pharma excels at navigating standard pharmaceutical product registration in Yemen, obtaining an exceptional pre-registration import authorization presents a unique set of challenges. Here’s what you need to know and how Sabrah Pharma can still be a valuable asset in this process.

Understanding Exceptional Pre-Registration Import Authorization

Standard pharmaceutical registration in Yemen involves obtaining approval for marketing and distributing a product for a specified period. However, exceptional pre-registration import authorization allows for the temporary import of a specific quantity of a pharmaceutical product that is not yet fully registered.

Important Note: Obtaining exceptional pre-registration import authorization is a complex process with stricter requirements compared to standard registration. It’s crucial to secure expert guidance to navigate the specific regulations and procedures involved.

Why Choose Sabrah Pharma for Exceptional Pre-Registration Import Authorization?

Given the complexities of exceptional pre-registration import authorization, partnering with an experienced and established company like Sabrah Pharma is vital. Here’s how we can help:

  • Regulatory Expertise: Our team possesses in-depth knowledge of Yemeni pharmaceutical regulations, including the nuances of exceptional pre-registration import authorization.
  • Compelling Application Preparation: We will work closely with you to assemble a comprehensive application that effectively justifies the need for exceptional authorization and adheres to all regulatory requirements.
  • Communication and Liaison: We can act as your intermediary with the Yemeni Ministry of Public Health and Population (MoPHP), ensuring clear communication and expediting the authorization process.
  • Project Management: We will manage the entire process from initial consultation to authorization, keeping you informed of progress and addressing any challenges that may arise.

By leveraging our experience and established relationships within the Yemeni pharmaceutical industry, Sabrah Pharma can significantly increase your chances of obtaining exceptional pre-registration import authorization for your critical product.

Partnering for Success

Even though exceptional pre-registration import authorization involves a complex process, Sabrah Pharma can be your partner in navigating this challenging landscape. Our expertise, guidance, and established relationships within the Yemeni pharmaceutical industry can significantly increase your chances of a successful application and ensure your essential medications reach those in need.

Working Together for Safer Medications in Yemen

Sabrah Pharma’s pharmacovigilance service is a testament to their unwavering commitment to patient safety in Yemen. By working collaboratively with healthcare professionals and patients, Sabrah Pharma plays a vital role in ensuring that medications used in Yemen are safe and effective.

  • Commitment
  • Quality
  • Strict procedures

The Importance of Reporting Medication Side Effects

Everyone plays a crucial role in ensuring medication safety. If you experience any side effects after taking a medication, it’s vital to report them. Here’s why:

Early identification of risks:

Reporting side effects helps identify potential safety concerns early on, preventing them from harming others.

Improved medication safety:

By reporting side effects, you contribute to a larger database of information that can be used to improve the safety of medications for everyone.

Informed treatment decisions:

Reporting side effects helps healthcare professionals make informed decisions about your individual treatment plan. 

Frequently Asked Questions (FAQs) Regarding Yemeni Pharmaceutical Product Registration

Here, we address some commonly asked questions regarding Yemeni pharmaceutical product registration:

Amina Omar
"Sabrah Pharma has been a reliable supplier of essential medicines for my patients at Al-Kuwait Hospital. Their medications are high-quality and affordable, which is crucial for our community. I also appreciate their ...

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Dr. Amina Omar
Physician, Al-Kuwait Hospital, Sana'a
"Sabrah Pharma has been a reliable supplier of essential medicines for my patients at Al-Kuwait Hospital. Their medications are high-quality and affordable, which is crucial for our community. I also appreciate their timely deliveries, ensuring uninterrupted patient care."
Amina Omar
Dr. Amina Omar
Physician, Al-Kuwait Hospital, Sana'a
Khalid Hassan
"Sabrah Pharma's dedication to ensuring access to essential medicines throughout Yemen is truly commendable. Their partnership with the Yemen Red Crescent Society has been instrumental in providing critical healthcare supplies to those ...

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Mr. Khalid Hassan
Director of Operations, Yemen Red Crescent Society
"Sabrah Pharma's dedication to ensuring access to essential medicines throughout Yemen is truly commendable. Their partnership with the Yemen Red Crescent Society has been instrumental in providing critical healthcare supplies to those in need. We are grateful for their support and collaboration."
Khalid Hassan
Mr. Khalid Hassan
Director of Operations, Yemen Red Crescent Society
Fatima Saleh
"As a community pharmacist in Taiz, I rely on Sabrah Pharma to provide my patients with a wide range of essential medications at fair prices. Their efficient distribution network ensures I can ...

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Pharmacist Fatima Saleh
Community Pharmacy Owner, Taiz
"As a community pharmacist in Taiz, I rely on Sabrah Pharma to provide my patients with a wide range of essential medications at fair prices. Their efficient distribution network ensures I can maintain a well-stocked inventory, allowing me to better serve my community. I highly recommend them to any pharmacy seeking a dependable supplier."
Fatima Saleh
Pharmacist Fatima Saleh
Community Pharmacy Owner, Taiz
Mohammed Al-Harazi
"In my practice as a physician in Aden, I have come to depend on the quality and efficacy of medications supplied by Sabrah Pharma. Their commitment to ethical practices and adherence to ...

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Dr. Mohammed Al-Harazi
Physician, Aden*
"In my practice as a physician in Aden, I have come to depend on the quality and efficacy of medications supplied by Sabrah Pharma. Their commitment to ethical practices and adherence to international standards gives me confidence in the products I prescribe to my patients. I wholeheartedly recommend them as a supplier you can trust."
Mohammed Al-Harazi
Dr. Mohammed Al-Harazi
Physician, Aden*
Layla Ahmed
"Thanks to Sabrah Pharma's efforts, I have been able to access the medication I need to manage my chronic health condition. Their dedication to affordability makes essential treatments possible for many Yemenis. ...

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Ms. Layla Ahmed
Resident of Sana'a
"Thanks to Sabrah Pharma's efforts, I have been able to access the medication I need to manage my chronic health condition. Their dedication to affordability makes essential treatments possible for many Yemenis. I am grateful for their service and commitment to the health of our community."
Layla Ahmed
Ms. Layla Ahmed
Resident of Sana'a
Hussein Ali
"In my work providing humanitarian aid in Yemen, I have witnessed firsthand the positive impact of Sabrah Pharma's work. Their focus on ensuring equitable access to medicines throughout the country is crucial ...

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Mr. Hussein Ali
International Aid Worker
"In my work providing humanitarian aid in Yemen, I have witnessed firsthand the positive impact of Sabrah Pharma's work. Their focus on ensuring equitable access to medicines throughout the country is crucial in addressing the healthcare needs of the Yemeni people. I commend their dedication to improving public health outcomes in Yemen."
Hussein Ali
Mr. Hussein Ali
International Aid Worker
Sabrah Pharma’s International Partners

Sabrah Pharma and EnoPharm are one group

By combining EnoPharm Group’s focus and agility with Sabrah Pharma’s experience and reach, the group is well-positioned to efficiently deliver high-quality pharmaceuticals to the market.

Enopharm 

At Sabrah Pharma, we believe everyone deserves access to high-quality medicines and healthcare products that empower them to live healthier, happier lives. That’s why we offer a comprehensive portfolio encompassing a diverse range of solutions, from essential pharmaceuticals to innovative supplements and beauty essentials.

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