Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 102

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 102
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 product marketing authorization, and MHRA guidance states that the United Kingdom will have the
power to take into account marketing authorizations made under the European Union decentralized and mutual recognition procedures. On
January 1, 2024, the MHRA launched the International Recognition Procedure (“IRP”), which provides for an expedited authorization
procedure for products that have received positive marketing authorization decisions from trusted partner agencies, such as the EMA or
the FDA. There are two available routes for assessment and recognition under the IRP:

●Recognition Route A - 60 days from validation of submission

oApplication must be based on a Reference Regulatory (“RR”), marketing authorization within the previous two years

oAny significant differences from the quality dossier approved by the RR marketing authorization requires assessment under Recognition
Route

oEvidence of cGMP compliance for manufacturing sites should be provided with submission

oNone of the Recognition Route B criteria are met

●Recognition Route B - 110 days from validation of submission with one planned clock stop (up to 60 days) at day 70 to allow applicant
to respond to issues identified during review

oApplication must be based on a RR marketing authorization within the previous 10 years

oCriteria requiring Recognition Route B include, among other things:

The RR marketing authorization granted a conditional or exceptional
circumstances marketing authorization

Additional manufacturing sites included in the application
were not assessed by the RR marketing authorization or a manufacturing site is not cGMP certified

There are substantial changes to the manufacturing process
compared to the process approved by the RR marketing authorization

Certain product types (e.g., advanced therapy medicinal products,
orphan medicines, over-the-counter medicines)

A RMP was not assessed under the RR marketing authorization

The RR marketing authorization required one or more post-authorization
safety studies for the product

A companion diagnostic is necessary for correct use of the
product

United Kingdom medicines legislation is subject
to future regulatory change under the Medicines and Medical Devices Act 2021. This act sets out a framework for the adoption of medicines
regulation.

Different rules apply in Northern Ireland following
implementation of the Northern Ireland Protocol, under which European Union central marketing applications continue to apply there. However,
in March 2023, the United Kingdom government and the European Commission reached agreement on a regulatory framework to replace the Northern
Ireland Protocol, referred to as the Windsor Framework. Effective as of January 1, 2025, the Windsor Framework introduced new rules for
the regulation of pharmaceutical products in