Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 159

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 4
Chunk 159
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 early dialogue with companies developing promising medicines, to optimize
their product development plans and speed up their evaluation to help them reach patients earlier. Product developers that benefit from
PRIME designation can expect to be eligible for accelerated assessment, but this is not guaranteed. The benefits of a PRIME designation
includes the appointment of a rapporteur from the Committee for Medicinal Product candidates for human use before submission of an MAA,
early dialogue and scientific advice at key development milestones, and the potential to qualify product candidates for accelerated review
earlier in the application process.

Israeli Government Regulations

Pursuant to the applicable laws & regulations
in Israel, and specifically the Dangerous Drugs Ordinance, 5733 - 1973, 2-aminoindane, including its isomers and structural derivatives
(which include MEAI), unless expressly excluded and excluding Rasagiline (R)-N-(prop-2-ynyl)-2,3-dihydro-1H-inden-1-amine ), is considered
a “dangerous substance” (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 Guid