The Essential Guide to Yemen Drug Registration (2)

by | Jun 18, 2024 | Regulatory affairs, A How-to Guide | 0 comments

The Essential Guide to Yemeni Drug Registration (2) , Drug Registration , Registration of Manufacturers process , registration drug process

The Essential Guide to Yemen Drug Registration (2)

Yemen’s health care system is undergoing a period of revitalization, creating new opportunities for foreign manufacturers to bring their life-saving products to the market. However, navigating the Yemeni regulatory landscape can be complex. Enopharm, your trusted partner in Yemeni regulatory affairs, is here to guide you through the entire process.
This comprehensive guide provides a roadmap for successfully registering your drugs products in Yemen. We’ll delve into the specific requirements for both manufacturer registration and individual product approval, ensuring you have all the necessary information to navigate the system with confidence.

This guide follows the previous one (Registering Pharmaceuticals in Yemen: A How-to Guide)

registering pharmaceuticals in yeme: a how to guide

A Step-by-Step Guide

This infographic outlines the key steps involved in registering drugs products for import and sale in Yemen. Partnering with a local distributor is your first crucial step, followed by navigating the Yemeni Ministry of Health (MOH) and Ministry of Industry and Commerce (MOIC).

Enopharm offices plan

Key Considerations for Foreign Manufacturers

Here’s a quick overview of some key aspects to keep in mind:

  • Demonstrating Manufacturing Quality: Yemen prioritizes product safety and efficacy. Obtaining a recognized Good Manufacturing Practice (GMP) certification, such as WHO GMP, cGMP, US FDA, or EMA, is a crucial first step. All certifications must be legalized by the Yemeni embassy.
  • Transparency through Detailed Documentation: A comprehensive Site Master File (SMF) outlining your manufacturing facilities, quality control procedures, and personnel qualifications is mandatory. Enopharm can assist you in creating an SBDMA-compliant SMF.
  • Partnering for Success: Appointing a local Yemeni distributor is essential for market access and effective product distribution. A legalized distribution agreement formalizes this partnership.
  • Potential for Additional Inspections: If your manufacturing facilities are not located within the Gulf Cooperation Council (GCC), a post-approval GMP inspection by Yemeni authorities might be required.

Understanding the Product Registration Process

Once your company is registered, you can proceed with individual product registration. This involves submitting a detailed product dossier to the Yemeni Supreme Board of Drugs and Medical Appliances (SBDMA) and the Ministry of Public Health (MOH). The dossier typically consists of two main sections:

  • Administrative Documents: This section provides essential information about your product, including a Free Sales Certificate or Certificate of Pharmaceutical Product (COPP), legalized by the Yemeni embassy, and your product’s GMP or Manufacturing License (also legalized).
  • Pharmaceutical Documents: This section delves deeper into the specifics of your product. It includes product information (name, manufacturer, price, composition, manufacturing process), quality assurance documents (Analysis Certificate, Insert Leaflet, methods of analysis), and stability and efficacy studies (shelf and accelerated stability reports, and bioequivalence studies for certain oral products).

Benefits of GCC Membership

As a member of the GCC, Yemen participates in efforts to harmonize the registration process across the region. This can streamline your registration journey and reduce redundancy. For certain products, a centralized registration and site inspection process involving Gulf auditors might apply across all seven GCC states, including Yemen.

A Detailed Look at the Registration Journey

While this introduction has provided a high-level overview, successfully registering your medical products in Yemen requires navigating specific steps and understanding the intricacies of the process. In the following sections of this guide, we’ll delve deeper into each stage, outlining the required documentation, potential challenges, and valuable tips to ensure a smooth and efficient registration process. Enopharm, with its in-depth knowledge of the Yemeni regulatory system and extensive experience navigating the GCC landscape, is here to support you every step of the way. Contact us today to discuss your specific needs and embark on a successful journey to bringing your valuable medical products to the Yemeni market.

 


Further Guidance on SBDMA Regulatory Requirements

For a more comprehensive understanding of the regulatory requirements set forth by the Supreme Board of Drugs and Medical Appliances (SBDMA), additional articles are available that delve into the specifics of the Site Master File (SMF) contents. These articles provide detailed explanations of the essential elements and data that manufacturers must include in their SMF submissions to meet SBDMA standards.

Additionally, there are articles that elucidate the registration requirements for pharmaceutical products. These resources offer valuable insights into the procedural steps, documentation, and compliance measures necessary for successful product registration in Yemen.

Should you have any inquiries or require further clarification on these matters, please do not hesitate to contact ENOPAHRM. We can assist you in navigating the regulatory landscape and ensuring adherence to all necessary guidelines.


 

Step 1: Company Registration

The Essential Guide to Yemeni Drug Registration (2) , Drug Registration , Registration of Manufacturers process , registration drug process

The journey to bringing your medical products to Yemen begins with establishing a firm foothold in the market. This crucial first step involves registering your company in Yemen. Think of it as planting your flag and declaring your commitment to serving the Yemeni healthcare system. Just like a sturdy foundation is essential for a building, a proper company registration acts as the base for your entire product registration application.

Why is Company Registration Important?

  • Local Presence: Yemeni regulations require foreign manufacturers to have a legal entity within the country. This registered company acts as the official representative for your products and facilitates communication with the Yemeni authorities.
  • Streamlined Process: A registered company simplifies the product registration process down the line. With a local presence established, you can act as a sponsor for your products and ensure smooth interactions with the regulatory bodies.
  • Market Access: Company registration opens the door to various market opportunities. It allows you to partner with local distributors, establish a brand presence, and participate in tenders for supplying medical products to hospitals and healthcare facilities in Yemen.

What Does Company Registration Entail?

The specific requirements for company registration can vary depending on the type of entity you choose to establish. However, some general steps typically include:

    1. Selecting a Business Structure: Decide on the most suitable legal structure for your Yemeni operations. Common options include a branch office, a liaison office, or a joint venture with a local Yemeni company.
    2. Appointing a Yemeni Company Representative: Crucially, before initiating the registration process, you’ll need to secure an agreement or authorization from a Yemeni company to act as your local legal representative. This individual or entity will be responsible for interfacing with Yemeni authorities on your behalf throughout the registration process and beyond. We’ll address this point further in Step 2:Manufacturer Registration Documents
    3. Gathering Required Documents: Prepare the necessary documentation, which may include your company charter, financial statements, and a business plan outlining your activities in Yemen.
    4. Registering with the Ministry of Industry and Commerce: File the completed application package with the relevant Yemeni authorities, typically the Ministry of Industry and Commerce.
    5. Obtaining Approval: Once your application is reviewed and approved by the Ministry of Industry and Commerce, you’ll receive a company registration certificate, officially establishing your legal presence in Yemen.
Enopharm Can Help:

Navigating the company registration process in Yemen can involve complexities and nuances. Enopharm, with its extensive experience and local expertise, can guide you through each step, ensuring a smooth and efficient registration experience. We can assist you in selecting the most suitable business structure, gathering the required documents, and liaising with the relevant authorities, including facilitating the process of finding and securing a qualified Yemeni company representative.

By establishing a strong foundation through proper company registration, you’ll be well-positioned to embark on the successful registration of your medical products in Yemen.


Step 2: Manufacturer Registration Documents

Now comes the paperwork for manufacturer registration, the first step towards getting your products approved in Yemen. The Supreme Board of Drugs and Medical Appliances (SBDMA) acts as the gatekeeper, and their goal is to ensure your manufacturing capabilities meet their strict standards for safety and quality. Think of it as assembling a powerful arsenal to prove your company’s commitment to producing life-saving products. Here’s what you’ll need to include:

1. GMP Certification:
  • This is your golden ticket. It demonstrates that your manufacturing facilities adhere to the World Health Organization’s stringent standards for Good Manufacturing Practices (GMP). Obtaining WHO GMP certification is a rigorous process, but it signifies your commitment to international quality benchmarks.
2. Manufacturing License:
  • A Manufacturing License is a mandatory document that certifies the manufacturer is authorized to produce pharmaceutical products.
  • It ensures that the manufacturing facilities comply with the necessary regulatory standards for quality and safety.
  • The license should be issued by a competent national or international regulatory authority.

The inclusion of a Manufacturing License in the registration dossier is a critical step that demonstrates the manufacturer’s adherence to international manufacturing standards and commitment to product quality. It is a key component that the SBDMA requires to ensure that all pharmaceutical products entering the Yemeni market are produced under conditions that meet the stringent requirements for Good Manufacturing Practice (GMP).

3. Site Master File (SMF):

This comprehensive document provides the SBDMA with a detailed virtual tour of your manufacturing facilities. It should include:

  • Facility overview: A description of your manufacturing site, including its location, size, and layout.
  • Equipment list: A detailed inventory of all the equipment used in your production process, along with their capabilities and maintenance schedules.
  • Personnel qualifications: Information about your staff, outlining their qualifications, experience, and roles within the production process. This demonstrates that you have a team of qualified professionals to ensure consistent quality.
  • Quality control procedures: A thorough explanation of your quality control systems, including testing procedures, documentation practices, and procedures for handling deviations or non-conformances. This transparency builds trust with the SBDMA.

Enopharm can be your trusted partner in navigating the complexities of the Site Master File. We understand the specific requirements of the Yemeni SBDMA and can provide guidance on compiling the necessary information. We can also offer sample SMF files as a starting point, tailored to different manufacturing setups. This valuable resource will save you time and ensure your SMF meets all the Yemeni registration requirements.

4. Agent’s Distribution Agreement:

Partnering with a local Yemeni distributor is crucial for successfully marketing and selling your products in the Yemeni market. This agreement outlines the terms and conditions under which your agent will handle the distribution process. It should clearly define responsibilities, pricing structures, and marketing strategies.

The Agent’s Distribution Agreement:

This legally binding document formalizes the partnership between your company and the Yemeni distributor. It clearly outlines the terms and conditions governing the distribution process, including:

  • Rights and Responsibilities: The agreement should clearly define the rights and responsibilities of both parties. This includes outlining the distributor’s authority to sell and promote your products, your responsibility for product supply and pricing, and the parameters for marketing and promotional activities.
  • Pricing Structure: Establish a clear pricing structure that determines the distributor’s margin and any potential volume discounts. The agreement should also address currency fluctuations and payment terms.
  • Marketing Strategies: Define the marketing strategies that will be employed to promote your products in the Yemeni market. This could include participation in trade shows, development of targeted marketing materials, and implementation of sales training programs for the distributor’s team.
  • Performance Expectations: Set clear performance expectations for your distributor, including sales targets and market penetration goals. The agreement should outline mechanisms for monitoring performance and addressing any potential issues.
  • Term and Termination: Specify the duration of the agreement and the conditions under which it can be terminated by either party.

By establishing a well-structured Agent’s Distribution Agreement, you can ensure a strong foundation for a successful and long-term partnership with your Yemeni distributor. This collaborative approach will empower you to effectively navigate the Yemeni market and deliver your life-saving medical products to the patients who need them most.

Enopharm’s Network Advantage:

Enopharm has established strong relationships with reputable Yemeni distributors across the country. We can leverage our network to help you find the right partner who aligns with your specific product line and market goals. Furthermore, we can assist you in negotiating and finalizing a comprehensive distribution agreement that safeguards your interests and paves the way for a successful market entry in Yemen.

5. Pharmacovigilance System Master File (PSMF): 

Document required by SBDMA to enhance registration: The Pharmacovigilance System Master File (PSMF) is a critical document that encapsulates the entirety of a manufacturer’s pharmacovigilance system. Here are some specific aspects and details that are typically included in a PSMF, which manufacturers need to consider when compiling this document for registration with the SBDMA in Yemen:

    1. Structure and Content of PSMF:
      • The PSMF should be structured in a way that provides a detailed description of the pharmacovigilance system.
      • It must include information on the safety profile of all products and describe how the system operates to monitor and manage risks associated with the use of the products.
    2. Qualified Person for Pharmacovigilance (QPPV):
      • The PSMF should contain details about the QPPV, including their responsibilities and how they oversee the pharmacovigilance system.
      • It should also provide information on the QPPV’s availability and contact details.
    3. Pharmacovigilance Processes:
      • Detailed descriptions of the processes for signal detection, risk assessment, risk management, and the preparation of regulatory submissions and reports should be included.
      • The PSMF should outline the standard operating procedures (SOPs) and the systems in place for managing pharmacovigilance data.
    4. Sources of Safety Data:
      • The PSMF should list all sources of safety data, including clinical trials, post-marketing studies, spontaneous reports, literature sources, and other surveillance systems.
    5. Risk Management Plans (RMPs):
      • Information on RMPs for each product should be included, detailing the measures taken to minimize risks and the effectiveness of these measures.
    6. Training and Competence:
      • The PSMF should describe the training provided to staff involved in pharmacovigilance activities and how their competence is maintained.
    7. Audits and Inspections:
      • Details of audits, inspections, and the outcomes of these activities should be documented within the PSMF.
      • Any corrective actions taken as a result of audits or inspections should also be included.
    8. Document Management:
      • The PSMF should include a section on document management, detailing how pharmacovigilance documents are created, revised, approved, and archived.
    9. Subcontracting of Pharmacovigilance Activities:
      • If any pharmacovigilance activities are subcontracted, the PSMF should reflect these arrangements and ensure that all subcontracted activities comply with the required pharmacovigilance standards.
    10. Annexes and Appendices:
      • The PSMF should have annexes and appendices that include lists of products, important pharmacovigilance contacts, and any other relevant documents.

It’s important to note that the PSMF is a living document that must be updated regularly to reflect changes in the pharmacovigilance system. Manufacturers should ensure that the PSMF is readily accessible and available for inspection by regulatory authorities at any time.

 

6. Legalization Process

The legalization process for the manufacturing license and the Good Manufacturing Practice (GMP) certificate, as required for pharmaceutical product registration in Yemen, involves several layers of authentication to ensure that the documents are officially recognized and valid. Here is an elaboration on the steps involved:

  1. Approval by Official Authorities:
    • Initially, the manufacturing license and the GMP certificate must be approved or Legalization by the official health or pharmaceutical regulatory authorities in the country of origin.
  2. Authentication by the Ministry of Foreign Affairs:
    • Following approval, these documents must be authenticated by the Ministry of Foreign Affairs in the country where the manufacturer is located. This step confirms that the documents are legitimate and are recognized by the government.
  3. Final Approval by the Yemeni Embassy:
    • The seal of the Ministry of Foreign Affairs must then be approved by the Yemeni embassy or its representative. In cases where there is no Yemeni embassy,
      Any Arab embassy can fulfil this role. This final step in the legalization process ensures that the documents are accepted for use in Yemen.
  4. Ratification of the Distribution Agreement:
    • The distribution agreement, which outlines the terms between the manufacturer and the local agent or distributor in Yemen, must also be ratified.
    • This ratification is done by the Chamber of Commerce and then by a notary public or according to the legal system followed in the manufacturer’s country.
  5. Final Authentication Steps:
    • After ratification by the Chamber of Commerce and the notary public, the agreement must go through the same authentication process by the Ministry of Foreign Affairs and then by the Yemeni Embassy or its representative.

By completing these steps, the manufacturing license, GMP certificate, and distribution agreement are fully legalized and ready to be submitted as part of the registration dossier to the Supreme Board of Drugs and Medical Appliances (SBDMA) in Yemen. This thorough process is designed to ensure the integrity and reliability of the documents, which is crucial for maintaining the standards of pharmaceutical products entering the Yemeni market.


Note on Document Legalization Requirements:

It is important to recognize that the documents necessitating legalization include the Good Manufacturing Practice (GMP) certificate, the manufacturing license, and the distribution or authorization agreement. These documents must undergo the official legalization process to be recognized by the Supreme Board of Drugs and Medical Appliances (SBDMA) in Yemen.

In contrast, the Site Master File (SMF) does not require legalization. However, it is essential to have the manufacturer’s seal on the file or the contents of the file. The SMF is a critical document for obtaining initial approval from the SBDMA. Following this approval, a factory inspection will be conducted for verification purposes.

Regarding the Pharmacovigilance System Master File (PSMF), the SBDMA may sometimes request its legalization by the official authorities and then by the embassy, as outlined for other documents. However, this requirement is not always consistent and may vary.


6. Additional Registration Requirement:

It is crucial to verify that there is no pre-existing customer in Yemen. This is because the registration process involves the following steps:

Ministry of Industry and Trade Review:
  • All documents are initially reviewed by the Ministry of Industry and Trade.
  • A card is issued by the Ministry confirming that the Yemeni company is the designated distributor of the manufacturer’s products, as stipulated in the agreement. This applies whether the agreement covers a single product or the manufacturer’s entire product range.
Process of Distributor Accreditation:
  • The accreditation process begins with the Ministry of Industry and Trade, where all documents are reviewed, and a card is issued confirming the Yemeni company’s distributorship status as per the agreement with the manufacturer.
  • These documents, along with the Ministry of Industry’s registration card, must then be submitted to the Ministry of Health.
  • The SBDMA technical committee will only accept the documents if accompanied by the registration card, which validates the distributorship accreditation.

This step is crucial to ensure that the manufacturer’s products are represented accurately and in accordance with the agreed terms of distribution in Yemen, thereby preventing any market conflicts or duplications.

By assembling this comprehensive set of documents, you’ll demonstrate to the SBDMA that your company possesses the expertise and infrastructure to produce safe and effective medical products. With Enopharm’s support, you can streamline the manufacturer registration process and pave the way for successful product approval in Yemen.


Step 3: Product Registration Requirements

The Essential Guide to Yemeni Drug Registration (2) , Drug Registration , Registration of Manufacturers process , registration drug process

Once your company is registered, you can move on to registering your specific products. Here’s where you demonstrate the quality and safety of each individual product you want to bring to market. This documentation serves as your evidence, convincing the SBDMA that your products pose no risk to Yemeni patients. Here are the key elements:

  • Free Sales Certificate: This document, issued by your country’s authorities, confirms that your products are freely available for export to Yemen.
  • Product Details Dossier: This comprehensive file includes everything from your product’s name and manufacturer to its composition, price, and manufacturing process. Consider it the product’s resume, highlighting its key features and specifications.

Product Details Dossier Template

This template can be used to compile the information required for the Product Details Dossier section of your Yemeni product registration application.

General Information
  • Product Name (English or Arabic): Provide the product name in both English and Arabic.
  • Manufacturer Name & Address: Include the full legal name and address of the product manufacturer.
  • Yemeni Agent Name & Address: If applicable, list the name and address of your authorized distributor in Yemen.
Product Description
  • Therapeutic Category: Specify the therapeutic category or class of medication (e.g., antibiotic, analgesic).
  • Dosage Form: Indicate the form of the product (e.g., tablet, capsule, injection).
  • Strength/Dosage: Detail the strength or dosage of the active ingredient(s) per unit (e.g., 500mg tablets).
  • Route of Administration: Specify how the product is administered (e.g., oral, topical).
Product Composition
  • Active Ingredient(s): List all active ingredients by name and quantity per unit dosage.
  • Excipients: Provide a complete list of inactive ingredients used in the product formulation.
Product Specifications
  • Packaging Information: Describe the packaging details, including the type of container, size, and quantity per unit (e.g., 100 tablets per bottle).
  • Shelf Life: Specify the product’s expiration date under recommended storage conditions.
  • Storage Conditions: Outline the ideal temperature, humidity, and light requirements for storing the product.
Additional Information
  • Authorization Status in Other Countries (Optional): If applicable, list any countries where the product is already registered and approved for marketing.
  • Summary of Product Claims: Provide a concise overview of the product’s intended therapeutic benefits.
  • Labeling (English & Arabic): Attach a copy of the product label in both English and Arabic, including all necessary information like dosage instructions, warnings, and contraindications.

Please note: This is a general template, and specific requirements may vary depending on the type of product you are registering. IIt is highly recommended to consult with us ENOPHARM as we are familiar with the Yemeni system for any additional information or specific forms needed for your product category.


Step 4: Quality and Safety Documentation

This step is crucial for convincing the Yemeni Supreme Board of Drugs and Medical Appliances (SBDMA) that your product is safe and effective for patients. Here’s a deeper dive into the required documentation:

1. Analysis Certificate:

  • This independent lab report, issued by a reputable laboratory accredited by a recognized body, verifies the ingredients and specifications of your product.
  • It should include:
    • Quantitative analysis of all active ingredients, ensuring they meet the declared potency and there are no unexpected variations.
    • Qualitative analysis to confirm the presence of all listed ingredients and identify any potential contaminants or impurities.
    • Test methods used with clear references to internationally recognized standards (e.g., USP, Ph. Eur.) to ensure the validity of the testing procedures.
  • The lab report acts as an independent verification of your product’s quality, building trust with the SBDMA.

2. Insert Leaflet:

  • This is the user manual for your product, serving as a crucial communication tool for Yemeni patients and healthcare professionals.
  • It should be translated into Arabic and include:
    • Clear and concise instructions on how to use the product safely and effectively, including dosage recommendations, administration methods, and duration of treatment.
    • Comprehensive safety information detailing potential side effects, contraindications (conditions where the product should not be used), and warnings for specific patient groups (e.g., pregnant women, children).
    • Storage instructions outlining proper storage conditions to maintain the product’s efficacy and stability.
  • A well-written insert leaflet empowers patients with the knowledge they need to use your product safely and effectively.

3. Finished/Standard/Reference Sample:

  • Providing actual samples of your product allows the SBDMA to conduct their own testing and analysis, giving them an extra layer of confidence in your product’s quality.
  • You may need to submit multiple samples, depending on the product type and specific SBDMA requirements.
  • Finished product samples represent the final product ready for market.
  • Standard or reference samples might be required for certain products, containing a known quantity of the active ingredient(s) to facilitate comparison during testing.
  • Ensure the samples are properly labeled with the product name, batch number, and expiry date.
  • Sending high-quality samples demonstrates transparency and your commitment to product quality.

4. Method of Analyses:

  • This document outlines the specific methods used by your company to analyze your product during the manufacturing process.
  • It ensures transparency and repeatability in the quality control process.
  • The document should detail:
    • Analytical techniques employed, referencing internationally recognized standards (e.g., USP, Ph. Eur.)
    • Acceptance criteria defining the acceptable range of values for each test parameter.
    • Equipment specifications used for the analyses.
  • By providing details on your quality control procedures, you demonstrate your commitment to consistent product quality throughout the manufacturing process.

Step 5: Stability and Efficacy Documentation – The Final Hurdle

The Essential Guide to Yemeni Drug Registration (2) , Drug Registration , Registration of Manufacturers process , registration drug process

In this final step, you’ll need to demonstrate that your product can withstand the test of time and deliver the intended therapeutic benefits. This documentation serves as crucial evidence for the Yemeni Supreme Board of Drugs and Medical Appliances (SBDMA) to approve your product for market.

Stability Reports:

  • These reports showcase how your product maintains its physical, chemical, and biological properties over time under various storage conditions.
  • Think of it as a stress test, ensuring that your product remains potent, safe, and effective throughout its shelf life.
  • The reports should include:
    • Study design: Outline the storage conditions tested (e.g., temperature, humidity, light exposure) and the duration of the study.
    • Test methods: Detail the analytical techniques used to assess product stability, such as measuring active ingredient content, degradation products, and physical properties.
    • Results and discussion: Present the data obtained from the stability studies, highlighting any trends or observations.
    • Conclusion: Summarize the findings and confirm that the product meets the specified stability requirements.

Accelerated Stability Studies:

  • While stability reports assess product performance under normal storage conditions, accelerated stability studies go a step further by subjecting the product to harsher-than-normal conditions.
  • This helps predict how the product will behave in extreme scenarios, such as high temperatures, humidity, or light exposure, that might occur during transportation or storage.
  • The studies should include:
    • Study design: Describe the accelerated conditions used (e.g., higher temperature, higher humidity), the duration of the study, and the storage conditions used as a control.
    • Test methods: Detail the analytical techniques used to assess product stability under accelerated conditions.
    • Results and discussion: Present the data obtained from the accelerated stability studies, highlighting any significant changes or degradation compared to the control samples.
    • Conclusion: Summarize the findings and demonstrate that the product can withstand accelerated conditions without compromising its quality or efficacy.

By providing comprehensive stability and efficacy documentation, you demonstrate your commitment to ensuring that your product remains safe, effective, and maintains its intended properties throughout its shelf life. This crucial information helps the SBDMA make an informed decision about the marketability of your product in Yemen.


The Road to Registration: Bringing Your Medical Products to Yemen

Navigating the Yemeni drug registration process may seem like a complex journey, but with the right preparation and approach, you can ensure your valuable medical products reach the patients who need them most. This guide has outlined the key steps involved, from establishing your company’s presence in Yemen to compiling the necessary documentation for each product.

This guide has outlined the key steps involved, from establishing your company’s presence in Yemen to assembling the necessary documentation for both manufacturer registration and individual product approval. Remember, this is just the first leg of the journey. The registration timeline can vary depending on the complexity of your product, typically ranging from 6 to 12 months. The SBDMA may require additional information or testing based on the specific product category and potential risks.

Enopharm, a trusted advisor in Yemeni regulatory affairs, can be your partner throughout this process. We can help you navigate the intricacies of manufacturer registration, including production line details, and ensure your product dossiers meet all the Yemeni requirements. Our team of experts can guide you through every step, from assembling the necessary documentation to addressing any questions or concerns raised by the SBDMA. We can assist you in:

  • Understanding the specific requirements for your product category.
  • Compiling and formatting the necessary documentation according to SBDMA guidelines.
  • Liaising with the authorities on your behalf to ensure a smooth application process.

Enopharm, a trusted advisor in Yemeni regulatory affairs, can be your partner throughout this process. We can help you navigate the intricacies of manufacturer registration, including production line details, and ensure your product dossiers meet all the Yemeni requirements. Our team of experts can guide you through every step, from assembling the necessary documentation to addressing any questions or concerns raised by the SBDMA.

While this guide provides a solid foundation, consulting with a regulatory expert familiar with the latest Yemeni regulations and nuances is highly recommended. Enopharm is here to help you overcome the hurdles and bring your life-saving products to the Yemeni market. Contact us today to discuss your specific needs and get started on a successful registration journey.

 

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