Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 103

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 103
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 the United Kingdom. Specifically, the MHRA is responsible for approving all medicines intended
to be marketed in the United Kingdom (including Northern Ireland), and the EMA is no longer involved in approving medicines intended for
sale in Northern Ireland.

32

The Trade and Cooperation Agreement, which sets
forth a framework for partnership between the European Union and the United Kingdom, became effective as of January 1, 2021. The Trade
and Cooperation Agreement between the European Union and the United Kingdom contains an Annex in relation to medicinal products with the
objective of facilitating availability of medicines, promotion of public health and consumer protection in respect of medicinal products.
The Annex provides for mutual recognition of cGMP inspections and certificates, meaning that manufacturing facilities do not need to undergo
duplicate inspections for the two markets. The Annex establishes a Working Group on Medicinal Products to deal with matters under the
Trade and Cooperation Agreement, facilitate co-operation and for the carrying out of technical discussions. It is expected that further
bilateral discussions will continue with respect to regulatory areas not the subject of the Trade and Cooperation Agreement, including
pharmacovigilance. The Trade and Cooperation Agreement also does not include reciprocal arrangements for the recognition of batch testing
certification. However, the United Kingdom has listed approved countries, including the EEA which will enable United Kingdom importers
and wholesales to recognize certain certification and regulatory standards. The European Commission has not adopted such recognition procedures.

It is expected that the establishment of a separate
United Kingdom authorization system, albeit with transitional recognition procedures in the United Kingdom, will lead to additional regulatory
costs. In addition, additional regulatory costs may be incurred with respect to the lack of mutual recognition of batch testing and related
regulatory measures.

Data Privacy and Security in the European
Union and the United Kingdom

The collection, use, disclosure, transfer, or other
processing of personal data regarding individuals in the European Union, including personal health data, is subject to the European Union’s
GDPR, which became effective on May 25, 2018. The GDPR is wide-ranging in scope and imposes numerous requirements on companies that process
personal data, including requirements relating to processing health and other sensitive data, obtaining consent of the individuals to
whom the personal data relates, providing information to individuals regarding data processing activities, implementing safeguards to
protect the security and confidentiality of personal data, providing notification of data breaches, and taking certain measures when engaging
third-party processors. The GDPR also imposes strict rules on the transfer