What is 29C Importation?
Regulation 29C governs the importation of non-registered medicinal products into Israel under specific conditions. This regulation allows hospitals, healthcare providers, and sponsors to access treatments that are not locally registered but are essential for patient care. These imports often support clinical trials, compassionate use programs, or off-label treatments when no registered alternative is available in Israel.
Types of 29C Importation
There are several categories of medicinal products that can be imported under Regulation 29C:
- Non-registered drugs included in the Israeli healthcare basket – These are approved for reimbursement but have not yet received formal registration in Israel.
- Non-registered drugs not included in the healthcare basket – These require additional approvals for use.
- Off-label use of registered drugs – Importation can be done on an individual or institutional basis.
- Compassionate use drugs – These medications are not registered in any country worldwide and are often life-saving, requiring urgent approval.
The Approval Process for 29C Importation
Because compassionate use cases are often urgent, the 29C process must be handled efficiently. Here’s a step-by-step overview of the process:
- Medical Justification – The treating physician at the requesting institution must complete a designated Ministry of Health (MoH) form (Form 2, 3, or 4). This form requires multiple signatures within the hospital and, in some cases, approval from external regulatory bodies.
- Importation Request Submission – After securing the required approvals, the importation request is submitted to the MoH for final authorization.
- One-Time Import Approval – Unlike standard import permits, 29C import approvals are always issued per invoice and do not cover ongoing shipments or general drug authorization.
Key Considerations for Sponsors and Importers
- Time Sensitivity – Many 29C import cases involve urgent or life-saving treatments, requiring fast and efficient handling.
- Regulatory Navigation – Each import request must comply with Israeli MoH requirements, making experienced regulatory support essential.
- Seamless Coordination – Working with an experienced clinical supply partner like IMP ensures proper documentation, smooth customs clearance, and on-time delivery to hospitals and trial sites.
Expert Importation Support with IMP
With extensive experience in managing complex importation processes, IMP ensures that investigational and compassionate-use drugs reach patients and trial sites efficiently. Our team works closely with regulatory authorities to obtain the necessary approvals, minimizing delays and ensuring compliance every step of the way.
🔗 Want to learn more about 29C importation? Contact us today!
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