Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 80

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 3
Chunk 80
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, the
United Kingdom left the European Union on January 31, 2020, commonly referred to as Brexit. Pursuant to the formal withdrawal arrangements
agreed to by the United Kingdom and the European Union, the United Kingdom was subject to a transition period until December 31, 2020,
or the Transition Period, during which European Union rules continued to apply. A trade and cooperation agreement that outlines the future
and trading relationship between the United Kingdom and the European Union was agreed to in December 2020.

Since a significant proportion of the regulatory
framework in the United Kingdom applicable to our business and our product candidates is derived from European Union directives and regulations,
Brexit has had, and will continue to have, a material impact on the regulatory regime with respect to the development, manufacture, importation,
approval and commercialization of our product candidates in the United Kingdom. For example, Great Britain is no longer covered by the
centralized procedures for obtaining European Union-wide marketing authorizations from the EMA, and a separate marketing authorization
will be required to market our product candidates, including MEAI in Great Britain. It is currently unclear whether the Medicines &
Healthcare products Regulatory Agency in the United Kingdom is sufficiently prepared to handle the increased volume of marketing authorization
applications that it is likely to receive. Any delay in obtaining, or an inability to obtain, any marketing approvals, as a result of
Brexit or otherwise, would delay or prevent us from commercializing our product candidates in the United Kingdom and limit our ability
to generate revenue and achieve and sustain profitability. We could face significant additional expenses to obtain regulatory approval
for our products in the United Kingdom.

If we fail to comply with environmental, health and safety laws
and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success
of our business.

Our research, development and manufacturing activities
and our third party manufacturers’ and suppliers’ activities involve the controlled storage, use and disposal of hazardous
materials, including the components of our product candidates and other hazardous compounds. We and our manufacturers and suppliers are
subject to laws and regulations governing the use, manufacture, storage, handling and disposal of these hazardous materials. In some cases,
these hazardous materials and various wastes resulting from their use are stored at our and our manufacturers’ facilities pending
their use and disposal. We cannot eliminate the risk of contamination, which could cause an interruption of our commercialization efforts,
research and development efforts and business operations, environmental damage