Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 155

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 4
Chunk 155
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 employees
and physical control of controlled substances through storage in approved vaults, safes and cages, and through use of alarm systems and
surveillance cameras. An application for a manufacturing registration as a bulk manufacturer (not a dosage form manufacturer or a repacker/relabeler)
for a Schedule I or II substance must be published in the Federal Register, and is open for 30 days to permit interested persons to submit
comments, objections or requests for a hearing. A copy of the notice of the Federal Register publication is forwarded by DEA to all those
registered, or applicants for registration, as bulk manufacturers of that substance. Once registered, manufacturing facilities must maintain
records documenting the manufacture, receipt and distribution of all controlled substances. Manufacturers must submit periodic reports
to the DEA of the distribution of Schedule I and II controlled substances, Schedule III narcotic substances, and other designated substances.
Registrants must also report any controlled substance thefts or significant losses, and must obtain authorization to destroy or dispose
of controlled substances. As with applications for registration as a bulk manufacturer, an application for an importer registration for
a Schedule I or II substance must also be published in the Federal Register, which remains open for 30 days for comments. Imports of Schedule
I and II controlled substances for commercial purposes are generally restricted to substances not already available from domestic supplier
or where there is not adequate competition among domestic suppliers. In addition to an importer or exporter registration, importers and
exporters must obtain a permit for every import or export of a Schedule I and II substance or Schedule III, IV and V narcotic, and submit
import or export declarations for Schedule III, IV and V non-narcotics. In some cases, Schedule III non-narcotic substances may be subject
to the import/export permit requirement, if necessary to ensure that the United States complies with its obligations under international
drug control treaties.

For drugs manufactured in the United States, the
DEA establishes annually an aggregate quota for the amount of substances within Schedules I and II that may be manufactured or produced
in the United States based on the DEA’s estimate of the quantity needed to meet legitimate medical, scientific, research and industrial
needs. This limited aggregate amount of cannabis that the DEA allows to be produced in the United States each year is allocated among
individual companies, which, in turn, must annually apply to the DEA for individual manufacturing and procurement quotas. The quotas apply
equally to the manufacturing of the API and production of dosage forms. The DEA may