Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 101

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 101
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 Key obligations include expedited reporting of
suspected serious adverse reactions and submission of periodic safety update reports (“PSURs”).

In addition, all new MAAs must include a risk management
plan, or RMP, describing the risk management system that the company will put in place and documenting measures to prevent or minimize
the risks associated with the product. The regulatory authorities may also impose specific obligations as a condition of the marketing
authorization. Such risk-minimization measures or post-authorization obligations may include additional safety monitoring, more frequent
submission of PSURs, or the conduct of additional clinical trials or post-authorization safety studies. RMPs and PSURs are routinely available
to third parties requesting access, subject to limited redactions.

Furthermore, the manufacturing of authorized products,
for which a separate manufacturer’s license is mandatory, must also be conducted in strict compliance with applicable cGMP requirements,
which mandate the methods, facilities and controls used in manufacturing, processing and packing of products to assure their safety and
identity.

Finally, the marketing and promotion of authorized
products, including industry-sponsored continuing medical education and advertising directed toward the prescribers of products, are strictly
regulated in the European Union under Directive 2001/83/EC, as amended. The advertising of prescription-only medicines to the general
public is not permitted in the European Union, or in the United Kingdom under the Human Medicines Regulations 2021. Although general requirements
for advertising and promotion of medicinal products are established under EU Directive 2001/83/EC as amended, the details are governed
by regulations in each European Union member state (as well as Iceland, Norway and Liechtenstein) and can differ from one country to another.

United Kingdom

As of January 1, 2021, European Union law no longer
directly applies in the United Kingdom. The United Kingdom has adopted existing European Union medicines regulation as standalone United
Kingdom legislation with some amendments to reflect procedural and other requirements with respect to marketing authorizations and other
regulatory provisions.

31

The MHRA, is responsible for regulating the United
Kingdom medicinal products market (Great Britain and Northern Ireland). An MHRA authorization must be obtained for each medicine to be
marketed in the regions that comprise the United Kingdom. On January 1, 2021, all European Union marketing authorizations were converted
to United Kingdom marketing authorizations subject to a manufacturer opt-out. The United Kingdom has introduced separate, specific processes
for regulatory submissions and medicinal