Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 199

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 199
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 has been Obtained

In case an authorization for
a medicinal product in the European Union is obtained, the holder of the marketing authorization is required to comply with a range of
requirements applicable to the manufacturing, marketing, promotion and sale of medicinal products. These include:

| • | Compliance with the European Union’s stringent pharmacovigilance or safety reporting rules must      
 be ensured. These rules can impose post-authorization studies and additional monitoring obligations. |

| • | The manufacturing of authorized medicinal products, for which a separate manufacturer’s license                                                    
 is mandatory, must also be conducted in strict compliance with the applicable European Union laws, regulations and guidance, including             
 Directive 2001/83/EC, Directive 2003/94/EC, Regulation (EC) No 726/2004 and the European Commission Guidelines for Good Manufacturing              
 Practice. These requirements include compliance with European Union cGMP standards when manufacturing medicinal products and active pharmaceutical 
 ingredients, including the manufacture of active pharmaceutical ingredients outside of the European Union with the intention to import             
 the active pharmaceutical ingredients into the European Union.                                                                                     |

| • | The marketing and promotion of authorized drugs, including industry-sponsored continuing medical education                               
 and advertising directed toward the prescribers of drugs and/or the general public, are strictly regulated in the European Union notably 
 under Directive 2001/83EC, as amended, and European Union Member State laws. Direct-to-consumer advertising of prescription medicines    
 is prohibited across the European Union.                                                                                                 |

Orphan Drug Designation and Exclusivity

The European Commission, following
an evaluation by the EMA’s Committee for Orphan Medicinal Products, has designed MTX110 as an orphan medicinal product. Pursuant
to Regulation (EC) No 141/2000 and Regulation (EC) No. 847/2000, the European Commission can grant orphan medicinal product designation
to products for which the sponsor can establish that it is intended for the diagnosis, prevention or treatment of a life-threatening or
chronically debilitating condition affecting not more than five in 10,000 people in the European Union, or a life threatening, seriously
debilitating or serious and chronic condition in the European Union and that without incentives it is unlikely that sales of the drug
in the European Union would generate a sufficient return to justify the necessary investment. In addition, the sponsor must establish
that there is no other satisfactory method approved in the European Union of diagnosing, preventing or treating the condition, or if such
a method exists