Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 204

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 204
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 some amendments to reflect procedural and other requirements with respect to marketing authorizations
and other regulatory provisions.

The Medicines and Healthcare
products Regulatory Agency, or MHRA, is responsible for regulating the United Kingdom medicinal products market (Great Britain and Northern
Ireland). In order to market medicines in the United Kingdom, manufacturers must hold a United Kingdom authorization. On January 1, 2021,
all European Union marketing authorizations were converted to United Kingdom marketing authorizations subject to a manufacturer opt-out.
The United Kingdom has introduced a separate UK-specific processes for regulatory submissions and medicinal product MA, and MHRA guidance
states that the United Kingdom will have the power to take into account marketing authorizations made under the European Union decentralized
and mutual recognition procedures. On January 1, 2024, the MHRA launched the International Recognition Procedure, or IRP, which provides
for an expedited authorization procedure for products that have received positive marketing authorization decisions from trusted partner
agencies, such as the EMA or the FDA. There are two available routes for assessment and recognition under the IRP:

| · | Recognition Route A – 60 days from validation of submission |

| o | Application must be based on a Reference Regulatory, or RR, MA within the previous two years |

| o | Any significant differences from the quality dossier approved by the RR requires assessment under Recognition 
 Route B                                                                                                       |

| o | Evidence of GMP compliance for manufacturing sites should be provided with submission |

| o | None of the Recognition Route B criteria are met |

| · | Recognition Route B – 110 days from validation of 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