Application for Marketing Approval of Homeopathic Products

In Israel, homeopathic products are marketed without an approved medical indication, similar to practices in the United States and the European Union. These products are not a substitute for conventional medical treatments, and their effectiveness has not been established through conventional scientific methods; therefore, they cannot be prescribed as a medical treatment. However, due to their use by some patients, monitoring potential quality and safety issues is important.

Required Application Materials

A complete list of required forms and documents can be found in the appendices to the Homeopathic Product Procedure (Hebrew).

How Do I Submit the Application?

1. Print the application form (Hebrew), fill it out manually, and mail the full form and documents on a disk to:
   The Pharmacy Division, Pharmaceutics and Drugs Import Department, 39 Yirmiyahu Street, Jerusalem, 9101002.
2. For packages of homeopathic products produced abroad, send them by mail to: The Pharmacy Division, Migdalei Habira, 39 Yirmiyahu Street, 2nd floor, room 284, Jerusalem 9101002.

For your information:

• The approval is valid for a five-year period.
• An application for renewal should be submitted three months before the approval expires.

Application Review Process

• If any details are missing, we will send an email to the applicants, requesting that they complete the documents or the missing data.
• The application processing timeline is approximately 30 days upon receipt of all the required documents.
• At the end of the process, a marketing authorization will be sent to the applicants via electronic mail.

Notes

• No homeopathic products for infants containing alcohol will be approved.
• Eye-drop marketing applications require product testing at the Institute of Pharmaceutical Standards and Quality Control.
• Homeopathic product imports are only permitted from recognized countries according to the Homeopathic Product Procedure (Hebrew). These countries include those in the European Union, Switzerland, Norway, Iceland, the United States, Canada, Australia, and Japan.