Company: CMND
Filing Date: 2025-12-05
Form Type: F-1/A
Source: 0001213900-25-118772
Chunk: 182

Company: Clearmind Medicine Inc.
Filing Date: 2025-12-05
Form: F-1/A
Chunk 182
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 (i.e. a “controlled substance”) and therefore, its importation to Israel requires a license, by the Israeli Ministry of Health, or the MOH. Once imported, the possession and use of such substance, for research purposes, requires the submission of a separate application to the MOH and a subsequent permit. Such permit will be considered by the MOH, as part of examining the application for a clinical trial to be conducted accordance with the applicable laws & regulations, as more fully described below. Clinical Trials in Human Subjects in Israel Clinical trials in Israel are conducted in accordance with the Public Health Regulations (Clinical Trials in Humans) 1980, and the updated MOH Clinical Trials Procedure No. 14. The MOH Clinical Trials Department is authorized to examine and grant approvals to clinical trials with human participants, in accordance with all the terms& conditions specified in the applicable legislation/regulations and supervise their actual performance. Any clinical trial (including planning, design, approval, conduct, documentation, recording, and reporting thereof) must be carried out while ensuring strict compliance with the following:

| ● | The principles of the Helsinki Declaration; |

| ● | the updated Public Health Regulations (Clinical Trials in Humans) 1980; |

| ● | the Genetic Information Law 2000; and |

| ● | the provisions of the applicable MOH Procedure and guidelines. |

In addition, every clinical trial must be carried out adhering to the following international guidelines:

| ● | The Harmonised Tripartite Guideline for Good Clinical Practice (ICH-GCP E6); and |

| ● | the International Standard Organisation (ISO); ISO 14155-1; ISO 14155-2: Clinical Investigation of Medical Devices for Human Subjects. |

In the event of an inconsistency between the aforesaid guidelines, the guidelines of the MOH shall prevail. In matters not covered by binding provisions in the guidelines of MOH, the international guidelines should be followed. Informed Consent in Human Clinical Trials Apart from exceptional cases, clinical trial participants must sign on an “informed consent” form, pre-approved by the applicable Helsinki Committee. Human Clinical Trials Pre-Conditions The following conditions must be met prior to the beginning of any such trial:

| 1. | Insurance – the sponsor of the trial must provide appropriate insurance coverage. |

| 2. | Free supply of the investigational product to the trial participants shall be guaranteed throughout the duration of the trial. A participant must not pay to participate in the trial. |

| 3.