The treating physician or healthcare institution determines that the patient requires an Unlicensed Medicine that is not registered in Israel.
Comprehensive Regulatory & Import Solutions
SK-Pharma provides end-to-end regulatory and import solutions for Unlicensed Medicines under Section 29 of the Israeli Pharmacists Ordinance. We support pharmaceutical companies, healthcare institutions and healthcare professionals in securing access to medicinal products that are not registered or commercially available in Israel, while ensuring full compliance with Israeli Ministry of Health requirements.
Certain medicinal products may be unavailable in the Israeli market due to regulatory, commercial or supply-related reasons despite a genuine medical need. In such cases, Section 29 provides a regulatory pathway for importing Unlicensed Medicines following professional review and authorization by the Israeli Ministry of Health.
When is Import under Section 29 Required?
Import under Section 29 may be required in the following situations:
Medicinal products approved in other countries but not yet launched in Israel
Medicinal products whose Israeli marketing authorization has expired
Medicinal products without an authorized local representative
Medicinal products not registered in Israel for commercial reasons
Clinical situations where no suitable registered therapeutic alternative is available
Why SK-Pharma
SK-Pharma specializes in the sourcing, importation, storage and distribution of Unlicensed Medicines from qualified international suppliers through a global pharmaceutical partner network.
Our services include:
Our services include:
Reliable sourcing from qualified manufacturers and authorized distributors
Full compliance with GDP, quality and safety standards
Regulatory coordination and transparent documentation
End-to-end project management and professional support
Every medicinal product is handled under strict quality assurance procedures—from international procurement through importation, storage and distribution in Israel, to delivery to the authorized healthcare institution or dispensing pharmacy.
How Does the Process Work?
Step 1
Medical Assessment
Step 2
Section 29 Application Submission
The treating physician or healthcare institution submits the appropriate Section 29 application (formerly Form 29C). Common application types include:
• Individual Application
• Institutional Individual Application
• Institutional Application
Individual approvals are generally valid for up to six months or until the approved quantity has been supplied, whichever occurs first.
Step 3
Ministry of Health Authorization & Import
Following Ministry of Health authorization, SK-Pharma coordinates the importation of the approved medicinal product.
Step 4
Supply
Following arrival in Israel, the medicinal product is dispensed through the authorized pharmacy or the relevant institutional pharmacy. A new authorization is required for each additional import.
Who Is This Service For?
Hospitals and medical centers
Health maintenance organizations (HMOs)
Institutional and clinical pharmacists
Physicians managing complex or special medical cases
Patients requiring Unlicensed Medicines through their treating healthcare institution
Additional Regulatory Information
For official information regarding the importation of Unlicensed Medicines under Section 29, please refer to the Israeli Ministry of Health website.
The Israeli Ministry of Health website
Contact Us
Our regulatory specialists will be pleased to support you throughout the entire Section 29 import process.
Frequently Asked Questions (FAQ)
What is Section 29?
Section 29 establishes the regulatory framework that allows the importation of Unlicensed Medicines into Israel when a justified medical need exists and no appropriate registered alternative is available.
When can an application be submitted?
Applications may be submitted when a medicinal product is not registered or marketed in Israel, when its registration has expired, or when no suitable therapeutic alternative exists.
Who may submit an application?
Applications must be submitted by the treating physician or an authorized healthcare institution in accordance with Ministry of Health requirements.
What application types are available?
Individual, Institutional Individual and Institutional Section 29 applications.
How long is an approval valid?
Individual approvals are generally valid for up to six months or until the approved quantity has been exhausted.
Can any Unlicensed Medicine be imported?
No. Every application is reviewed individually by the Israeli Ministry of Health based on medical, regulatory and safety considerations.
How does SK-Pharma support the process?
We provide regulatory guidance, global sourcing, importation, logistics and compliant distribution throughout the entire supply chain.
Which medicines may be imported?
Eligible products may include oncology medicines, orphan drugs, biological medicines, innovative therapies, medicines in temporary shortage, products not registered or marketed in Israel, and medicines for which no suitable therapeutic alternative exists. Every request is assessed individually by the Ministry of Health.
Contact Us
Our regulatory specialists will be pleased to support you throughout the entire Section 29 import process.
+972 3 6114543 | 29c@sk-pharma.com | +972529279344