Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 53

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 53
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 the products, manufacturing or ourselves; or |

| • | seize or detain products, refuse to permit the import or export of products or require a product recall. |

In the EU, the EMA may require
an equivalent risk management plan, or RMP. Non-compliance with European Union requirements regarding safety monitoring or pharmacovigilance
can also result in significant financial penalties. Similarly, failure to comply with the European Union’s requirements regarding
the protection of personal information can also lead to significant penalties and sanctions.

The occurrence of any of these
events or penalties described above may inhibit our ability to generate revenue from product candidates that are commercialized by any
of our licensing partners.

The FDA’s, EMA’s,
MHRA’s, and other comparable foreign regulatory authorities’ policies may change and additional government regulations may
be enacted that could prevent, limit or delay regulatory approval of our product candidates. If we are slow or unable to adapt to changes
in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we
may lose any marketing approval that we may have obtained, which would adversely affect our business, prospects and ability to achieve
or sustain profitability.

Obtaining and maintaining regulatory approval of any of our other product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions.

Obtaining and maintaining
regulatory approval of our other product candidates in one jurisdiction does not guarantee that we will be able to obtain or maintain
regulatory approval in any other jurisdiction, while a failure or delay in obtaining regulatory approval in one jurisdiction may have
a negative effect on the regulatory approval process in others. For example, even if the FDA grants marketing approval of a product candidate,
similar foreign regulatory authorities must also approve the manufacturing, marketing and promotion of the product candidate in those
countries. Approval and licensure procedures vary among jurisdictions and can involve requirements and administrative review periods different
from, and greater than, those in the United States, including additional nonclinical studies or clinical trials as clinical trials conducted
in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions. In many jurisdictions outside the United States,
a product candidate must be approved for reimbursement before it can be approved for sale in that jurisdiction. In some cases, the price
that we intend to charge for our products is also subject to approval.

We may also submit marketing
applications in other countries. Regulatory authorities in jurisdictions outside of the United States have requirements