Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 52

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 52
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 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 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,