Application for Drug Registration Renewal
This service allows you to submit an application for drug registration renewal and pay online for the renewal.
A license for marketing a drug in Israel is granted for five years (drug registration certificate). If you are interested in continuing to market the drug, the registration must be renewed, extending the registration validity for an additional ten years.
- Drug registration renewal requires a quality certificate issued by the Institute for Standardization and Control of Pharmaceuticals. The application for a quality certification (Hebrew) should be submitted nine months before the drug registration expires.
- An application for drug registration should be submitted to the Pharmaceutics Division no later than 30 days before the drug registration expires.
- Quality certificate from the Institute for Standardization and Control of Pharmaceuticals.
- All required forms and documents in accordance with the Application for Medical Devices Registration Procedure (Hebrew).
- First, submit an application for a quality certificate (Hebrew) from The Institute for Standardization and Control of Pharmaceuticals.
- Then, print the application for drug registration renewal, fill it out and submit it with the quality certificate and the required documents by one of the following methods:
Bureau
In-person submission by appointment to the Pharmaceutics Registration Department in the Pharmacy Division during visiting hours.
Send it by mail to the Registration Department in the Pharmaceutical Division at 39 Yirmiyahu Street, Jerusalem 9446724.
Payments can be made using one of the following methods:
- Online: Pay through the government payment system.
- Postal Bank: use a payment slip in account number 03807-9.
- Amendments to the drug composition do not require a fee.
- Amendments to other details require a fee.
- If any documents are missing, a request letter will be sent by email or fax.
- Amendment approval will be sent by email, and the original will be sent by mail.
Please note, if there is any difference or conflict between the information on this page and the law, the provisions of the law will apply.
Ministry of Health
Hotline and Information Center
Contact Information
Phone Service Hours
- Sunday to Thursday: 8:00 AM – 6:00 PM
- Friday and holiday eves: 8:00 AM – 1:00 PM
- Intermediate festival days (Sukkot and Passover): 8:00 AM – 2:00 PM
Address: 39 Jermiahu St., Jerusalem
Mailing Address: P.O. Box 1176, Jerusalem 9101002