Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 54

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 54
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 compliance with cGMP and other applicable regulations. If a previously unknown problem
with a product, such as adverse events of unanticipated severity or frequency, or a problem with the facility where the product is manufactured
is discovered, a regulatory agency may impose restrictions on that product, the manufacturing facility or the party commercializing the
product, including requiring recall or withdrawal of the product from the market or suspension of manufacturing. If our product candidates
or the manufacturing facilities for our product candidates fail to comply with applicable regulatory requirements, a regulatory agency
may:

| • | issue warning letters or untitled letters; |

| • | mandate modifications to, or the withdrawal of, marketing and promotional materials or require corrective 
 information to be provided to healthcare professionals;                                                   |

| • | require the violating party to enter into a consent decree, which can include the imposition of various              
 fines, reimbursements of inspection costs, required due dates for specific actions and penalties for non-compliance; |

| • | seek an injunction or impose civil or criminal penalties or monetary fines; |

| • | require revisions to the labeling, including limitations on approved uses or the addition of additional 
 warnings, contraindications or other safety information, including boxed warnings;                      |

| • | suspend, vary or withdraw regulatory approval; |

| 28 |

| • | require additional post-market clinical trials to assess the safety of the product; |

| • | suspend any ongoing clinical studies; |

| • | refuse to approve pending applications or supplements to applications filed by us or any licensing partner; |

| • | suspend or impose restrictions on operations, 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