Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 202

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 202
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s, the term “product” means the active ingredient or combination of active ingredients
for a medicinal product and the term “patent” means a patent protecting such a product or a new manufacturing process or application
for it. The duration of an SPC is calculated as the difference between the patent’s filing date and the date of the first marketing
authorization, minus five years, subject to a maximum term of five years.

A six month pediatric extension
of an SPC may be obtained where the patentee has carried out an agreed pediatric investigation plan, the authorized product information
includes information on the results of the studies and the product is authorized in all member states of the European Union.

| 100 |

United Kingdom Regulation

From January 1, 2021, European
Union law no longer directly applies in the United Kingdom. The United Kingdom has adopted existing European Union medicines regulation
as standalone United Kingdom legislation with 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