Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 39

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 3
Chunk 39
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 all areas of regulatory compliance, including manufacturing,
production and quality control.

Any regulatory approvals that we may receive for
our product candidates may contain requirements for potentially costly post-marketing testing, such as Phase 4 clinical trials and surveillance
to monitor the safety and efficacy of a drug product. We are required to report certain adverse reactions and production problems, if
any, to the FDA, the EMA and other comparable foreign regulatory authorities. Any new legislation addressing drug or medical safety issues
could result in delays in product development or commercialization or increased costs to assure compliance.

The FDA and other agencies, including the U. S.
Department of Justice, and for certain products, the Federal Trade Commission, closely regulate and monitor the post-approval marketing,
labeling, advertising and promotion of products to ensure that they are manufactured, marketed and distributed only for the approved indications
and in accordance with the provisions of the approved label. We are, and will be, required to comply with requirements concerning advertising
and promotion for our product candidates, if approved. For example, promotional communications with respect to prescription drugs and
medical devices are subject to a variety of legal and regulatory restrictions and must be consistent with the information in the product’s
label or labeling. Accordingly, we may not promote our products for indications or uses for which they do not have approval.

The holder of an approved NDA, MAA or equivalent
marketing authorization must submit new or supplemental applications and obtain approval for certain changes to the approved product,
product labeling, or manufacturing process. Delays in obtaining required approvals would harm our ability to introduce new or enhanced
product in a timely manner, which in turn would harm our or our future growth. Failure to submit a new or supplemental application and
to obtain approval for certain changes prior to marketing the modified product may require a recall or to stop selling or distributing
the marketed product as modified and may lead to significant enforcement actions.

In the European Economic Area, or the EEA, any
medical devices will need to comply with the Essential Requirements set forth in Medical Device Regulation. Compliance with these requirements
is a prerequisite to be able to affix the CE mark to a product, without which a product cannot be marketed or sold in the EEA. To demonstrate
compliance with the Essential Requirements and obtain the right to affix the CE mark, we must undergo a conformity assessment procedure,
which varies according to the type of medical device and its classification. The conformity assessment procedure requires the intervention
of a Notified Body, which is an