Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 95

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 95
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 countries. The approval
process varies from country to country and the time may be longer or shorter than that required for FDA approval. In addition, the requirements
governing the conduct of clinical trials vary greatly from country to country.

27

European Union and United Kingdom

In the European Economic Area (“EEA”),
which is comprised of the Member States of the European Union plus Norway, Iceland and Liechtenstein, medicinal products can only be commercialized
after obtaining marketing authorization from the European Medicines Agency (“EMA”). Under EU regulatory systems, we must submit
and obtain authorization for a clinical trial application in each member state in which we intend to conduct a clinical trial. When conducting
clinical trials in the European Union, we must adhere to the provisions of the European Union Clinical Trials Directive (Directive 2001/20/EC)
and the laws and regulations of the EU Member States implementing them. These provisions require, among other things, that the prior authorization
of an Ethics Committee and the competent Member State authority is obtained before commencing the clinical trial. In 2014, the new Clinical
Trials Regulation, (EU) No 536/2014, Clinical Trials Regulation, was adopted and it became effective on January 31, 2022. The Clinical
Trials Regulation is directly applicable in all of the EU Member States, as it repealed the Clinical Trials Directive 2001/20/EC. The
extent to which ongoing clinical trials will be governed by the Clinical Trials Regulation depends on when the Clinical Trials Regulation
became applicable and on the duration of the individual clinical trial. If a clinical trial continues for more than three years from the
day on which the Clinical Trials Regulation became applicable (i.e., beyond January 30, 2025), the Clinical Trials Regulation will at
that time begin to apply to the clinical trial.

The Clinical Trials Regulation aims to simplify
and streamline the approval of clinical trials in the European Union. The main characteristics of the regulation include: a streamlined
application procedure via a single-entry point, the “EU portal” or Clinical Trial Information System (“CTIS”);
a single set of documents to be prepared and submitted for the application as well as simplified reporting procedures for clinical trial
sponsors; and a harmonized procedure for the assessment of applications for clinical trials, which is divided in two parts. Part I is
assessed by the competent authorities of all EU Member States in which an application for authorization of a clinical trial has been submitted
(Member States concerned).