Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 201

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 201
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 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, the proposed orphan drug will be of significant benefit to patients.

| 99 |

Orphan drug designation is
not a marketing authorization. It is a designation that provides a number of benefits, including fee reductions, regulatory assistance,
and the possibility to apply for a centralized European Union marketing authorization, as well as ten years of market exclusivity following
a marketing authorization. During this market exclusivity period, neither the EMA, the European Commission nor the member states can accept
an application or grant a marketing authorization for a similar medicinal product. A “similar medicinal product” is defined
as a medicinal product containing a similar active substance or substances as those contained in an authorized orphan medicinal product
and that is intended for the same therapeutic indication. The market exclusivity period for the authorized therapeutic indication may
be reduced to six years if, at the end of the fifth year, it is established that the orphan designation criteria are no