Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 96

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 96
---
 Part II is assessed separately by each Member State concerned. Strict deadlines have been established for the
assessment of clinical trial applications. The role of the relevant ethics committees in the assessment procedure will continue to be
governed by the national law of the concerned EU Member State. However, overall related timelines will be defined by the Clinical Trials
Regulation. Use of the CTIS became mandatory for new clinical trial application submissions as of February 1, 2023.

After we have completed our clinical trials, we must obtain marketing
authorization before we can market our drug products in the European Union. We may submit Marketing Authorization Applications (“MAA”)
under the centralized procedure or one of the national authorization procedures.

The EMA is a body of the European Union located
in Amsterdam. The EMA is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European
Union. The EMA is involved in the scientific evaluation of medicines that fall within the scope of the centralized procedure. Like the
FDA, there is a harmonization between regulators and the EMA may inspect and audit the development facilities, planned production facilities,
clinical trial sites and laboratory facilities. Additionally, after the product is approved and marketed, the EMA uses various mechanisms
for assuring that firms adhere to the terms and conditions of approval described in the application and that the product is manufactured
in a consistent and controlled manner.

Centralized Procedure

The centralized procedure provides for the grant
of a single marketing authorization by the European Commission, through the EMA, that is valid throughout the EEA. This marketing authorization
process is compulsory for medicines produced by specified biotechnological processes, products designated as orphan medicinal products,
advanced-therapy medicines (such as gene-therapy, somatic cell-therapy or tissue-engineered medicines) and products with a new active
substance indicated for the treatment of specified diseases, such as HIV/AIDS, cancer, diabetes, neurodegenerative disorders or autoimmune
diseases and other immune dysfunctions and viral diseases. For those products for which the use of the centralized procedure is not mandatory,
applicants may elect to use the centralized procedure where either the product contains a new active substance indicated for the treatment
of diseases other than those on the mandatory list, or where the applicant can show that the product constitutes a significant therapeutic,
scientific or technical innovation, or for which a centralized process is in the interest of public health.

28

Under the centralized procedure, the Committee
for Medicinal Products for Human Use (the