The treating physician or healthcare institution determines that the patient requires an Unlicensed Medicine that is not registered in Israel.
Comprehensive Regulatory & Import Solutions
At SK-Pharma, we provide professional services for the import of medicines that are not registered or not marketed in Israel, in accordance with Regulation 29 of the Pharmacists’ Ordinance and the guidelines of the Israeli Ministry of Health.
Certain medicines are unavailable on the Israeli market for various reasons – regulatory, commercial, or logistical – despite a genuine medical need for them. In such cases, medicines may be imported from abroad under special approval pursuant to Regulation 29, following professional review and authorization by the competent authorities.
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
Legal and Regulatory Disclaimer
The information on this page is provided for general informational purposes only, in connection with the sourcing and importation of medicinal products in accordance with applicable Israeli law and regulatory frameworks. Nothing on this page — including any reference to a medicinal product, active ingredient (INN), trade name, manufacturer, or therapeutic area — constitutes advertising, a recommendation for use, medical advice, an offer for sale, or any commitment to source, import, supply, or ensure the availability of any medicinal product.
Rights in Medicinal Products and Trade Names. Trade names, trademarks, manufacturer names, and product names mentioned on this page, where mentioned, are the property of their respective legal owners. They are referenced solely for identification and informational purposes. The mere mention or presentation of a medicinal product, active ingredient, manufacturer, or trademark does not constitute any claim by SK-Pharma to ownership of the medicinal product, trade name, trademark, or any related intellectual property rights.
Unless expressly stated otherwise, SK-Pharma is not the manufacturer, marketing authorization holder (“MA holder”), brand owner, or trademark owner of the medicinal products mentioned on this page, and does not represent itself as acting on their behalf. The mention of any medicinal product, manufacturer, or brand does not create or imply any commercial relationship, partnership, representation, authorization, sponsorship, endorsement, or approval by the manufacturer, MA holder, brand owner, or trademark owner.
Sourcing, Importation, and Supply. The appearance of a medicinal product or active ingredient on this page does not indicate that the product is registered in Israel, available for purchase or importation, or that approval for its importation or supply can be obtained. Each request for sourcing, importation, or supply is assessed on an individual basis and is subject, among other things, to the availability of the product, the source of supply, applicable law and regulatory requirements, and any prescription, approval, or permit required by the Israeli Ministry of Health or any other competent authority, including under Regulation 29, where applicable.
No reference to any specific medicinal product shall be construed as a commitment by SK-Pharma to obtain, import, or supply it.
Medical Information. The information on this page does not constitute, and is not intended to constitute, medical advice, diagnosis, a treatment recommendation, or a recommendation to use any medicinal product, and is not a substitute for consultation with a physician, pharmacist, or other qualified healthcare professional. Any decision regarding medical treatment, the suitability of a medicinal product for a patient, or the use of a medicinal product shall be made by the authorized medical professionals and in accordance with applicable law. Any list of medicinal products, active ingredients, or therapeutic areas appearing on this page, where applicable, is for illustrative purposes only, is not exhaustive, and may change from time to time.
* Please do not report adverse events through this form or include any personal or sensitive information in the message box. To report a suspected adverse event or other safety-related information, please contact our Pharmacovigilance team at report@sk-pharma.com