Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 204

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 204
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 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 UK 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.

Healthcare Law and Regulation

Healthcare providers, physicians
and third-party payors play a primary role in the recommendation and prescription of drug products that are granted marketing approval.
Arrangements with third-party payors and customers are subject to broadly applicable fraud and abuse and other healthcare laws and regulations.
Such restrictions under applicable federal and state healthcare laws and regulations include the following:

| • | the federal Anti-Kickback Statute prohibits, among other things, persons from knowingly and willfully                                    
 soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the    
 referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made, in whole 
 or in part, under a federal healthcare program such as Medicare and Medicaid; A person or entity does not need to have actual knowledge  
 of the Anti-Kickback Statute or specific intent to violate it to have committed a violation;                                             |

| • | the federal civil and criminal false claims laws and civil monetary penalty laws, including the federal                                    
 False Claims Act, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, false 
 or fraudulent claims for payment to, or approval by Medicare, Medicaid, or other federal healthcare programs, knowingly making, using      
 or causing to be made or used a false record or statement material to a false or fraudulent claim or an obligation to pay or transmit      
 money to the federal government, or knowingly concealing or knowingly and improperly avoiding or decreasing