Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 97

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 97
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 “CHMP”), which is the EMA’s committee that is responsible for human medicines,
established at the EMA is responsible for conducting the assessment of whether a medicine meets the required quality, safety and efficacy
requirements, and whether it has a positive benefit/risk profile. The maximum timeframe for the evaluation of a MAA is 210 days from the
receipt of a valid MAA, excluding clock stops when additional information or written or oral explanation is to be provided by the applicant
in response to questions of the CHMP. Clock stops may extend the timeframe of evaluation of a MAA considerably beyond 210 days. Where
the CHMP gives a positive opinion, it provides the opinion together with supporting documentation to the European Commission, which makes
the final decision to grant a marketing authorization. Accelerated evaluation may be granted by the CHMP in exceptional cases, when a
medicinal product is expected to be of major interest to the public health and, in particular, from the viewpoint of therapeutic innovation.
If the CHMP accepts such a request, the timeframe for assessment is 150 days (excluding clock stops), but it is possible that the CHMP
may revert to the standard review timeframe for the centralized procedure if it determines that the MAA is no longer appropriate to conduct
an accelerated assessment.

National Authorization Procedures

There are also two other possible routes to authorize
medicinal products in several EU countries, which are available for investigational medicinal products that fall outside the scope of
the centralized procedure:

●Decentralized procedure. Using the decentralized procedure, an applicant may apply for simultaneous authorization in more than one
EU country of medicinal products that have not yet been authorized in any EU country and that do not fall within the mandatory scope of
the centralized procedure.

●Mutual recognition procedure. In the mutual recognition procedure, a medicine is first authorized in one EU Member State, in accordance
with the national procedures of that country. Following this, further marketing authorizations can be sought from other EU countries in
a procedure whereby the countries concerned agree to recognize the validity of the original, national marketing authorization.

Under the above-described procedures, before granting
the marketing authorization, the EMA or the competent authorities of the Member States of the EEA make an assessment of the risk-benefit
balance of the product on the basis of scientific criteria concerning its quality, safety and efficacy.

PRIME Scheme

EMA offers a scheme that is intended to reinforce
early dialogue with, and regulatory support from, EMA in order to