Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 195

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 195
---

of European Union law into account. Before arriving at a final decision on an application for centralized authorization of a medicinal
product the European Commission must consult the Standing Committee on Medicinal Products for Human Use. The Standing Committee is composed
of representatives of the European Union Member States and chaired by a non-voting European Commission representative. The European Parliament
also has a related “droit de regard.” The European Parliament's role is to ensure that the European Commission has not exceeded
its powers in deciding to grant or refuse to grant a marketing authorization.

The European Commission may
grant a so-called “marketing authorization under exceptional circumstances.” Such authorization is intended for products for
which the applicant can demonstrate that it is unable to provide comprehensive data on the efficacy and safety under normal conditions
of use, because the indications for which the product in question is intended are encountered so rarely that the applicant cannot reasonably
be expected to provide comprehensive evidence, or in the present state of scientific knowledge, comprehensive information cannot be provided,
or it would be contrary to generally accepted principles of medical ethics to collect such information. Consequently, marketing authorization
under exceptional circumstances may be granted subject to certain specific obligations, which may include the following:

| • | the applicant must complete an identified program of studies within a time period specified by the competent 
 authority, the results of which form the basis of a reassessment of the benefit/risk profile;                |

| • | the medicinal product in question may be supplied on medical prescription only and may in certain cases                                  
 be administered only under strict medical supervision, possibly in a hospital and in the case of a radiopharmaceutical, by an authorized 
 person; and                                                                                                                              |

| 97 |

| • | the package leaflet and any medical information must draw the attention of the medical practitioner to                                    
 the fact that the particulars available concerning the medicinal product in question are as yet inadequate in certain specified respects. |

A marketing authorization
under exceptional circumstances is subject to annual review to reassess the risk-benefit balance in an annual reassessment procedure.
Continuation of the authorization is linked to the annual reassessment and a negative assessment could potentially result in the marketing
authorization being suspended or revoked. The renewal of a marketing authorization of a medicinal product under exceptional circumstances,
however, follows the same rules as a “normal” marketing authorization. Thus, a marketing authorization under exceptional circumstances
is granted for an initial five years, after which the authorization will become valid indefinitely, unless the EMA decides that safety
grounds merit one additional five-year renewal