Import unapproved medicine into Israel

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Importing Unapproved Life-Saving Medicine for Personal Use into Israel

The Pharmacists Ordinance (New Version) (1981) outlines the regulations and requirements for importing medicines into Israel. For individuals seeking to import life-saving medication that is unapproved or unavailable in Israel, there are specific procedures to ensure the safety and legality of such imports. This document provides a comprehensive overview of the requirements and steps necessary to import unapproved life-saving medicine for personal use into Israel.

Legal Framework

The importation of medicines is strictly regulated to protect public health. Under the Pharmacists Ordinance, the Ministry of Health oversees the approval and monitoring of all pharmaceuticals entering the country. For unapproved medications, especially those essential for saving lives, the Ministry provides a pathway for personal importation under specific conditions.

Conditions for Importation

To import an unapproved life-saving medication for personal use, the following conditions must be met:

1. Medical Necessity

The medication must be essential for treating a life-threatening condition. There should be no suitable alternative treatment available within Israel. A licensed physician must attest to the necessity of the medication.

2. Prescription Requirement

An official prescription from a physician registered in Israel is required. The prescription must include detailed information about the patient, the medication, dosage, and the diagnosis necessitating its use.

3. Medical Documentation

A detailed medical report or letter from the treating physician must accompany the prescription. This document should explain the patient's medical condition, the urgency of the treatment, and why alternative medications approved in Israel are not adequate.

4. Quantity Limitations

The quantity of medicine imported should not exceed a three-month supply for personal use. For chronic conditions requiring long-term treatment, renewals are possible but must follow the same approval process.

5. Manufacturer and Quality Assurance

The medication must be manufactured by a recognized pharmaceutical company and approved for use in its country of origin. Proof of the medication's approval status abroad may be required.

Application Procedure

The process to obtain approval for importing unapproved life-saving medicine involves several steps:

1. Submission of Request

The individual or their representative must submit a formal request to the Ministry of Health's Pharmaceutical Division. This can often be done through an online portal or by mail.

2. Required Documentation

The application must include:

• Prescription from a registered Israeli physician.
• Medical report detailing the necessity of the medication.
• Details of the medication, including composition and manufacturer information.
• Importation details, such as the supplier and method of shipment.

Additional documents may be requested by the authorities to support the application.

3. Review Process

The Ministry of Health will review the application to ensure all criteria are met. This includes verifying the medical necessity, the absence of alternatives, and the credibility of the manufacturer.

4. Approval and Importation

Once approved, the individual will receive authorization to import the medication. The approval document should be presented to customs officials upon the medication's arrival in Israel to facilitate its release.

Customs Clearance

Medications are subject to customs regulations. The individual must ensure that all necessary customs declarations are completed and that the medication complies with import regulations. Having the Ministry of Health's approval documentation readily available is crucial during this stage.

Limitations and Considerations

1. Personal Use Only

The imported medication must be solely for the personal use of the individual named in the prescription. Distribution or sale of the medication is strictly prohibited and may result in legal action.

2. Safety and Compliance

Ensuring the medication's authenticity and safety is paramount. Counterfeit or substandard medicines pose significant health risks. It is advisable to source medications from reputable suppliers.

3. Renewal of Approval

For ongoing treatments, approvals may need to be renewed. The individual should keep track of approval expiry dates and submit renewal applications in a timely manner to prevent interruptions in treatment.

Alternative Options

If importing medication is not feasible, individuals might consider the following:

• Consulting with medical professionals about alternative treatments available in Israel.
• Participating in clinical trials or special access programs for experimental drugs.
• Seeking assistance from patient advocacy groups or charities that support access to medications.

Contact Information

For further assistance, individuals can contact the Ministry of Health directly:

• Ministry of Health Website
• Pharmaceutical Division: [Insert Contact Information]

References

• Pharmacists Ordinance (New Version) (1981)
• Ministry of Health - Personal Importation of Medicines
• Ministry of Health - Importing Medical Equipment

Conclusion

Importing unapproved life-saving medication into Israel is a process designed to provide access to essential treatments while safeguarding public health. By adhering to the regulations set forth in the Pharmacists Ordinance and the guidelines provided by the Ministry of Health, individuals can navigate the importation process effectively. It is important to plan ahead, ensure all documentation is complete, and maintain open communication with healthcare providers and regulatory authorities throughout the process.