Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 53

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 53
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 | marketing of such product may be suspended; |

| • | a product recall or product withdrawal; |

| • | regulatory authorities may withdraw approvals of such product or may require additional warnings on the 
 label;                                                                                                  |

| • | the requirement to develop a REMS for each product or, if a strategy is already in place, to incorporate                           
 additional requirements under the REMS, or to develop a similar strategy as required by a comparable foreign regulatory authority; |

| • | the requirement to conduct additional post-market studies; and |

| • | being sued and held liable for harm caused to subjects or patients. |

Consequently, our reputation and business operations
may suffer.

Any of these events could
prevent the achievement or maintaining of market acceptance of the particular product or product candidate, if approved, and could significantly
harm our business, results of operations and prospects.

Even if we receive regulatory approval of any product candidates, we will be subject to ongoing regulatory oversight and continued regulatory review, which may result in significant additional expense and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with any of our product candidates.

Our product candidates, if
they receive regulatory approval, will be subject to the ongoing requirements of the EMA, the MHRA, the FDA and other regulatory agencies
governing the manufacture, quality control, further development, labeling, packaging, storage, distribution, safety surveillance, import,
export, advertising, promotion, recordkeeping and reporting of safety and other post-market information. These requirements include submissions
of safety and other post-marketing information and reports, establishment registration and listing, as well as continued compliance with
cGMP for product manufacturing and GCP requirements for any clinical trials that we conduct post-approval. The safety profile of any product
is closely monitored by the EMA, the MHRA, the FDA and other regulatory authorities after approval. If the EMA, the MHRA, the FDA or other
regulatory authorities become aware of new safety information after approval of any of our products or product candidates, regulatory
authorities may require labeling changes or establishment of a risk mitigation strategy or similar strategy, impose significant restrictions
on a product’s indicated uses or marketing, or impose ongoing requirements for potentially costly post-approval studies or post-market
surveillance.

In addition, manufacturers
of drug and biological products and their facilities are subject to continual review and periodic inspections by the EMA, the MHRA, the
FDA and other governmental regulatory authorities for