Application for District Pharmacy Approval for Private Use of Unapproved Drugs in Israel
In Israel, community pharmacists may request approval from district pharmacists for the personal use of unregistered medications by individuals, as well as for unapproved uses of registered medications.
Who Can Submit the Application
- Pharmacists in community-based pharmacies who need to dispense the preparation.
- The service is not intended for pharmacies of medical institutions (such as hospitals and HMO clinics).
- The service is not intended for patients.
- The applying pharmacy must be defined in the system.
- If the pharmacy doesn't appear, contact the Department for the Import of Pharmaceutics and Drugs.
Required Documents
Form 3 or 5 for the Director's Consent, completed and signed by the physician, including the requested indications. Pharmacists must ensure the form is fully completed.
- Form 3: Physician's order for the use of a unlisted preparation in a medical institution (for an individual patient) (Hebrew)
- Form 5: Physician's order for the use of an unlisted preparation or for the maintenance of stock (for a pharmacy) (Hebrew)
- For unregistered preparations in Israel, attach an information handbook from a recognized state.
- If the indication is not approved in the handbook, attach guidelines and protocols from relevant professional associations.
Application Process
Pharmacists in a pharmacy (defined in system 29) where patients submitted Form 29 from their treating physician will submit an online application for approval to use an unregistered drug (Hebrew).
Process details:
- Access the online form using a smart card.
- Fill in the new application form.
- Select a drug and indication from the list, and enter details from the individual Form 29 submitted.
For information and assistance with the smart card (Hebrew)
- Form 29 constitutes a prescription for all intents and purposes.
- Form 29 is valid for six months from the physician's signature date.
- For continued treatment, submit a new application with a renewal form.
Application Processing
- The pharmacy submits the application online to the district pharmacist based on the pharmacy's location.
- The district pharmacist reviews the application and makes a decision.
- The decision is sent online to the applying pharmacy (approval, rejection, or request for additional information).
- If approved, pharmacists dispense the preparation.
- For unregistered preparations requiring import, the pharmacy can handle it.
- For approved off-label use of registered preparations, the pharmacy dispenses to patients.
Please note that if there’s any discrepancy or conflict between the information on this page and the applicable law, the law will take priority.
Ministry of Health
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