Registering Pharmaceuticals in Yemen: A How-to Guide (1)

by | Feb 7, 2024 | Pharmaceuticals, A How-to Guide, Regulatory affairs | 0 comments

Essential Steps for Registering Pharmaceuticals in Yemen: A How-to Guide

Essential Steps for Registering Pharmaceuticals in Yemen: A How-to Guide

Registering Pharmaceuticals in Yemen

Essential Steps for Registering Pharmaceuticals in Yemen: A How-to Guide (Yemen’s pharmaceutical market is experiencing growth, with the nation keen to welcome foreign manufacturers of medical products and devices, signaling opportunities for companies invested in drugs in Yemen  Regulatory oversight in Yemen is managed by the Supreme Board of Drugs and Medical Appliances (SBDMA) and the Ministry of Public Health, emphasizing the importance of understanding local compliance to successfully register and distribute drugs in Yemen

Navigating the complexities of the regulatory environment requires specialized knowledge, particularly as the MENA region, including Yemen, poses a blend of opportunities and challenges for pharmaceutical companies aiming to introduce their drugs to Yemen . Each country within the MENA has unique health authority guidelines and registration requirements, highlighting the necessity for tailored strategies for those looking to expand their presence in Yemen).


For a detailed breakdown of each registration step, along with the required documentation and valuable tips, refer to Guide 2: [The Essential Guide to Yemeni Drug Registration (2) ] Enopharm


Understanding Yemen’s Pharmaceutical Registration Requirements

Manufacturer Registration Requirements

  1. Certifications Required: Manufacturers must have WHO GMP, cGMP, US FDA, or EMA certifications, all of which need legalization by the Yemeni embassy.
  2. Site Master File Submission: A detailed Site Master File must be provided during the registration process.
  3. Agent’s Distribution Agreement: A legalized distribution agreement with a local agent is necessary.
  4. GMP Inspection: If the manufacturer is not registered within the GCC, a GMP inspection is mandated post-initial approval.

Product Dossier Requirements

Administrative Documents

  • Free Sales Certificate / COPP: Must be legalized by the Yemeni embassy.
  • Product’s GMP or Manufacturing License: Also requires legalization by the Yemeni embassy.

Pharmaceutical Documents

  • Product Information: Includes the product name, manufacturer’s name, CIF price at Sana’a airport, composition, and manufacturing process.
  • Quality Assurance Documents: An Analysis Certificate, Insert Leaflet, and methods of analysis are required.
  • Stability and Efficacy Studies: Stability reports for shelf and accelerated conditions, and a bioequivalence study for oral products as required.

Registration Process with SBDMA and MOH

  • Approval Requirement: Manufacturers must obtain approvals from the Supreme Board of Drugs and Medical Appliances (SBDMA) and the Ministry of Public Health to enter the market.
  • GCC Centralized Procedure: Involves a separate registration and site inspection by Gulf auditors, applicable to all seven Gulf states including Yemen.
  • Harmonization Efforts: As part of the GCC, Yemen benefits from harmonization efforts that simplify the registration process and reduce redundancy.

Additional Regulatory Insights

  • Company Registration: A prerequisite in Yemen and other MENA countries, often requiring detailed documentation such as the MAH company profile and manufacturing facility details.
  • Emerging Market Challenges: Registration in emerging markets like Yemen involves navigating varying requirements and potential regulatory delays.

The Registration Process Step-by-Step

Required Documentation and Compliance

  1. Company Registration: Initially, companies must fulfill the company registration requirement, which is a pivotal step for progressing towards product approval in Yemen.
  2. Document Submission: The registration process mandates the submission of a comprehensive set of documents to ensure compliance with the standards set by the Supreme Board of Drugs and Medical Appliances (SBDMA). These documents include:
    • WHO GMP certification
    • Site Master File
    • Agent’s distribution agreement
    • Free sales certificate
    • Product’s GMP or Manufacturing License
    • Product details such as name, manufacturer’s name, price (CIF at Sana’a airport), composition, and manufacturing process.
  3. Quality and Safety Documentation:
    • Analysis certificate
    • Insert leaflet
    • Finished/Standard/Reference sample
    • Method of analyses.
  4. Stability and Efficacy Documentation:
    • Stability report for shelf conditions for three batches
    • Accelerated stability study for three batches
    • Bioequivalence study (required only for oral products).

Compliance Verification

  • Review and Approval: Post-document submission, the Registration Department at Sbdma conducts a thorough review to ensure all submitted information aligns with the regulatory requirements of the SBDMA.
  • Inspection and Final Approval: Following the initial review, further inspections or audits might be required to verify the compliance of the manufacturing site and the authenticity of the documents provided. Upon successful verification, final approval is granted, allowing the pharmaceutical products to be registered and marketed in Yemen.

Navigating Regulatory Challenges in Yemen

Understanding the Challenges in Yemen’s Pharmaceutical Sector

  1. Health System and Resource Limitations: Yemen’s health system faces significant challenges due to prolonged insecurity and conflict. These include a severe lack of financial resources, inadequate organizational structures, low reporting capacities, insufficient funding, and a scarcity of health professionals.
  2. Addressing Organized Crime and Regulatory Compliance: The United Nations Office on Drugs and Crime (UNODC) has initiated a five-year Integrated Country Programme to combat organized crime, which includes efforts to prevent illicit trafficking and terrorism financing. This program also focuses on strengthening Yemen’s legislative and regulatory frameworks to ensure that drugs and crime do not impede the country’s social and economic development.
  3. Pharmaceutical Sector Insights: The book “Pharmaceutical Sector in Yemen: Challenges and Recommendations” provides an in-depth analysis of the current state of Yemen’s pharmacy sector. It discusses critical health challenges, administrative issues, government actions, and public perception, offering a comprehensive overview of the obstacles and future challenges.

Regulatory Requirements and Assistance

  1. Gulf Regulatory Environment: The Gulf Central Committee for Drug Registration (GCC-DR) outlines specific procedures for drug registration in the Gulf states, including Yemen. These procedures necessitate a separate company registration and site inspection by Gulf auditors, which can significantly extend the timeline for market entry .
  2. Localized Regulatory Support: Freyr, a global Regulatory partner, provides localized Regulatory services to assist foreign manufacturers in navigating Yemen’s complex Regulatory regime. Their services include Strategic Regulatory Consulting, Regulatory roadmap for market access, and comprehensive support for obtaining Market Authorizations.

Moh / Yemen – Summary of Registration Guidelines

  1. Registration Requirements for Manufacturer with SBDMA:

WHO GMP / cGMP / US FDA /EMIA (legalized by the Yemeni embassy). Site Master file. Agent’s distribution agreement legalized by the Yemeni embassy Products catalogue Note: GMP inspection will be required if the company is not registered in GCC. This will be required after getting the initial approval for company registration.

  • Product dossier should include the following documents:
  • Administrative documents:
  • Free sales Certificate / COPP legalized by the Yemeni embassy
  • Product’s GMP or Manufacturing License legalized by the Yemeni embassy. ​
  • Pharmaceutical documents:
    1. Product’s Name.
    2. Manufacturer’s name
    3. Price- CIF Sana’a airport
    4. Omposition
    5. Manufacturing process
    6. Analysis Certificate
    7. Insert Leaflet
    8. Finished/Standard/Reference sample (for registration & Analyses Required Qty:
      ■ Tablets and caps=100 tabs/caps    ■  Vial/amp=60vials/amp
    1. Method of Analyses
    2. Stability Report
    3. Stability study on Shelf for 3 batches
    4. Accelerated Stability study for 3 batches

Want to dive deeper?

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. For a detailed breakdown of each registration step, along with the required documentation and valuable tips, refer to Guide 2: [The Essential Guide to Yemeni Drug Registration (2) ] Enopharm, with its in-depth knowledge of the Yemeni regulatory system and extensive experience navigating the Yemeni & 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.

Conclusion

Throughout this guide, we’ve delved into the intricate process of registering pharmaceuticals in Yemen, highlighting the essential steps required to comply with the local regulatory framework overseen by the Supreme Board of Drugs and Medical Appliances (SBDMA) and the Ministry of Public Health. By summarizing the key requirements ranging from manufacturer certifications to product dossier essentials, along with navigating both the registration process and potential regulatory challenges, this article aims to equip stakeholders with the knowledge necessary for successful market entry. The emphasis on the importance of understanding and adhering to the specific regulatory landscape in Yemen underscores the pivotal role of strategic planning and compliance in accessing the pharmaceutical market within this region.

Given the complexities and challenges outlined, the road to registering pharmaceutical products in Yemen demands not only a thorough understanding of the procedural requirements but also an awareness of the broader implications this has for companies aiming to expand their presence in emerging markets. The significance of such efforts goes beyond regulatory compliance, extending into the potential impact on public health and the healthcare landscape in Yemen. As stakeholders consider these insights, the call for further research and collaborative efforts to streamline the registration process and enhance access to essential medicines in Yemen remains clear, signaling an ongoing commitment to improving healthcare outcomes in the region.

FAQs

Q: What organization oversees drug regulation in Yemen?
A: The Yemen Supreme Board of Drugs (SBDMA) is the authority responsible for the regulation of drugs in Yemen.

Q: Can you explain the ICH guidelines for pharmaceuticals?
A: The ICH guidelines are a series of recommendations aimed at ensuring that medicines are safe, effective, and of high quality. These guidelines facilitate the development and registration of pharmaceuticals and are recognized by regulatory authorities globally.

Q: What does pharmaceutical regulation entail?
A: Pharmaceutical regulation is a framework established to guarantee the safety, effectiveness, and quality of drugs made available to the public.

Q: What is the purpose of pharmaceutical registration?
A: Pharmaceutical registration is a process that ensures a drug product has undergone rigorous testing and evaluation for safety, efficacy, and quality. It also verifies that the manufacturer’s product information is truthful and accurate.

ََQ: What types of pharmaceutical products does Enopharm help register in Yemen?
A: We have experience registering a wide range of medication categories, including:
Prescription and over-the-counter drugs
Generic and branded pharmaceuticals
Biological and biosimilar products
Medical devices and diagnostics
If your product falls outside these categories, please contact us to discuss its specific registration requirements.

Q:What types of pharmaceutical products does Enopharm distribute?
A: We have a diverse product portfolio encompassing a wide range of therapeutic areas, including chronic diseases, infectious diseases, women’s health, and more. We partner with reputable manufacturers to ensure high-quality medications cater to various patient needs. If you have a specific product in mind, please share details with our team, and we’ll let you know if we can handle its distribution.

Registering Pharmaceuticals in Yemen

 

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