Application to Register a New Drug for Marketing

• Anyone seeking to register a new drug.
• Applicants must meet the following criteria:
  • Israeli representatives of the drug manufacturer.
  • Rights owners located abroad.
• The application must be submitted by a licensed pharmacist authorized by the Ministry of Health.

An application to register a new drug must include the following four dossiers:

Dossier A:

• A new drug registration application form.
• Declarations and documents regarding manufacturing plants and drugs.
• Pamphlets and product labelling suggestions.
•  All CDs related to the application.

Dossier B:

All pre-clinical and clinical trial data.

Dossier C:

• Summary of data from dossier B.
• Scientific publications.
• Computerized reference list.
• Proposed brochure.
• Summary letter.

Dossier D:

A file comparing the drug's biological availability to the standard.

• Service is subject to a fee.
• Accepted fee payment methods:
  • Online: At the governmental payment service website.
  • Mail: Send a payment slip to the Postal Bank, account number 03807-9.

Print the application form to register a new drug, fill it out, and submit it along with all required documents in person after scheduling an appointment at the Registration Department of the Pharmaceutical Division during visiting hours at: 39 Yirmiyahu Street, Jerusalem 9446724.

1. If all documents are found to be in order, an approval number will be issued upon application submission.
2. The Registration Department of the Pharmaceutical Division and the Institute for Standardization and Control of Pharmaceuticals will review your documents to issue a quality certificate.
3. Depending on the drug type, your application will be submitted to the relevant committee for discussion.
4. If all tests are found to be in order, your drug will be registered in the Drug Registry.
5. A registration approval will be sent upon request by email.
6. The original registration and quality certificates will be mailed to you.

• Licenses are granted for five years.
• Any change to a registered drug must be notified. Additionally, you must renew its registration before its expiration date.

• If your application has been rejected, you may appeal the decision within six months of the date of rejection.
• Include any additional data in the appeal requested by the committee and submit your appeal by mail to: Ministry of Health, Registration Department of the Pharmaceutical Division, 39 Yirmiyahu Street, Jerusalem 9446724.