Medicines and medical devices special import permit by Ethiopian Food and Drug Authority

Medicines and medical devices special import permit by Ethiopian Food and Drug Authority

Medicines and medical devices special import permit by Ethiopian Food and Drug Authority

This blog simplifies the Ethiopian Food and Drug Authority’s (EFDA) guideline on obtaining a special import permit for medical products.

Ensuring Access to Critical Medical Products

The healthcare system relies on a steady flow of vital medical products. But sometimes, standard import procedures can’t meet urgent needs. That’s where special import permits come in. The Ethiopian Food and Drug Authority has created a special system where citizens who are in need of urgently required medical products can get access to such products.

This blog explains how these permits work and who can benefit from them.

What is a Special Import Permit?

A special import permit is a system that allows institutions or individuals to bring in medical products from outside the country under specific circumstances. These circumstances can include:

  • Emergencies: When a sudden crisis creates a critical shortage of medical supplies.
  • Unmet medical needs: For illnesses where there are no available treatment options within the country.
  • Shortages: To address temporary gaps in the local supply of essential medical products.
  • Donations: To facilitate the import of medical equipment or medications for charitable purposes.
  • Personal use: For individuals who require specific medication unavailable locally.
  • Health promotion and research: To bring in medical products for public health campaigns or clinical trials.

What is a Pre-Import Permit?

A pre-import permit is a specific type of special import permit issued by the EFDA to institutions. This permit allows them to import medical products under the circumstances mentioned above.

Who Can Apply for a Special Import Permit?

The eligibility for applying for a special import permit is currently for the following entities.

  • Hospitals and other healthcare institutions
  • Research institutions
  • Non-profit organizations
  • Individuals with a documented medical need

Why Safe medical product matters, Especially in Emergencies?

Imagine needing a life-saving medication, but finding out it’s fake or hasn’t been properly checked for safety. This is a harsh reality for many, especially in low- and middle-income countries.

The Balancing Act: Quality vs. Access

Unlike other products, medicines and medical devices need strict controls. This ensures patients receive safe and effective treatments. But strict regulations of the products can also make it harder for people to get the health services they need. This can be due to:

  • Economic constraints: Countries might not have the resources for proper testing and approval processes.
  • Meeting High Standards: Following strict quality guidelines can be challenging.
  • Urgent Needs: Emergencies might demand fast access to medication, leaving little time for thorough checks.

Fake Medical Products Pose a Serious Threat

When quality controls are relaxed, the door opens for falsified and substandard medicines and medical devices. These pose serious health risks and make it harder to treat real illnesses.

Finding Solutions: Balancing Speed with Safety

So, how can we make sure people get the products they need, while still guaranteeing safety? Here are some key strategies:

  • Faster Approvals: Streamlining the approval process for essential medicines and medical devices can save valuable time in emergencies.
  • Special Permits: Granting temporary permits for unregistered products can be crucial during emergencies or for unmet medical needs.

The Importance of Special Import Permits

Special import permits play a crucial role in ensuring access to vital medical products. They allow for a more flexible response to emergencies, unmet medical needs, and shortages. This can save lives and improve health outcomes for many people.

Ethiopia Taking Action

Ethiopia’s food and drug authority (EFDA) is a great example. They’ve developed a system to provide special permits for:

  • Unregistered medicines and medical devices needed in emergencies
  • Medicines and medical devices for rare diseases with no market interest
  • Medical products for clinical trials and research

Do you need a special permit?

You typically need a pre-import permit if the medicine or medical device you’re importing is:

  • Not registered in Ethiopia
  • For a specific use (e.g., emergency, clinical trial)
  • Only for your company’s employees

General Requirements:

  • Apply online through the EFDA’s Electronic Regulatory Information System (eRIS).
  • Include justification documents explaining why you need a special permit.
  • Pay the necessary fees after approval.

Types of Special Permits and Requirements:

  1. Emergency Use:
    • Must be on the list of approved supplies for the emergency.
    • Supporting letter from MoH or Regional Health Bureau.
    • Proof of unmet medical need due to the emergency.
    • Documents for the medical product (e.g., certificate of analysis, free sale certificate).
  2. Unmet Medical Need & Shortage:
    • Evidence of unmet medical need and shortage in Ethiopia.
    • Supporting letter from MoH or Regional Health Bureau.
    • Documents for the medical product (same as emergency use).
    • For unregistered products: Clinical justification for using the product.
  3. Clinical Investigation or Research:
    • Sample labeling showing “For clinical trial only” or “For research purpose only”.
    • Clinical trial approval letter from EFDA or research proposal approval.
    • Documents for the investigational product (e.g., Certificate of Analysis).
  4. Healthcare Investment:
    • Only applies to capital equipment (medical devices).
    • Supporting letter indicating the device is for a new investment or facility expansion.
    • Documents for the medical device (e.g., free sale certificate, user manual).
  5. Employee Use by Firms:
    • Only allowed if there’s a confirmed shortage.
    • Supporting letter from a relevant government agency or MoH.
    • Documents for the medical product (same as emergency use).
    • Number of employees who will use the product.
  6. Health Promotion:
    • Supporting letter from the relevant government body.
    • Statement of intended benefit of the health promotion activity.
    • Letter from the exhibition organizer (if applicable).
    • Sample label stating “for sampling or demonstration only”.

Additional Points:

  • Used or refurbished medical devices can be imported under special circumstances if they meet safety and functionality requirements.
  • Special permits are valid for one year, with possible extensions.
  • Personal use medical products with a prescription don’t require a pre-import permit.
  • EFDA may inspect imported products and request usage reports from institutions with special permits.

Please refer to the document for further information (Guideline on Medical Products Special import permit).

If you have any questions regarding the special importation permit of medical products by Ethiopian Food and Drug Authority, please contact the head of Evaluation and Market Authorization department for the respective product types (Medicines and Medical devices).

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