Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 203

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 203
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 submission with one planned clock stop (up to 
 60 days) at day 70 to allow applicant to respond to issues identified during review             |

| · | Application must be based on a RR marketing authorization within the previous ten years. |

| · | Criteria requiring Recognition Route B include, among other things: |

| § | The RR granted a conditional or exceptional circumstances marketing authorization |

| § | Additional manufacturing sites included in the application were not assessed by the RR or a manufacturing 
 site is not GMP certified                                                                                 |

| § | There are substantial changes to the manufacturing process compared to the process approved by the RR |

| § | Certain product types (e.g., advanced therapy medicinal products, orphan medicines, over-the-counter medicines) |

| § | A Risk Management Plan was not assessed by the RR |

| § | The RR required one or more post-authorization safety studies for the product |

| § | A companion diagnostic is necessary for correct use of the product |

United Kingdom medicines legislation
is subject to future regulatory change under the Medicines and Medical Devices Act 2021. This act sets out a new framework for the adoption
of medicines regulation.

Different rules apply in Northern
Ireland following implementation of the Northern Ireland Protocol, under which European Union central marketing applications continue
to apply there. However, in March 2023, the United Kingdom government and the European Commission reached agreement on a regulatory
framework to replace the Northern Ireland Protocol, referred to as the Windsor Framework. The Windsor Framework is expected to apply as
of January 1, 2025 and will change the existing system under the Northern Ireland Protocol, including the regulation of pharmaceutical
products in the UK. Specifically, the MHRA will be responsible for approving all medicines intended to be marketed in the UK (i.e., Great
Britain and Northern Ireland), while the EMA will no longer be involved in approving medicines intended for sale in Northern Ireland.

| 101 |

The Trade and Cooperation Agreement, which sets
forth a framework for partnership between the European Union and the United Kingdom, became effective as of January 1, 2021. The
Trade and Cooperation Agreement between the European Union and the United Kingdom contains an Annex in relation to medicinal products
with the objective of facilitating availability of medicines, promotion of public health and consumer protection in respect of medicinal
products. The Annex provides for mutual recognition of good manufacturing practice (GMP) inspections and certificates, meaning that manufacturing
facilities do not need to undergo duplicate inspections for the two markets. The