Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 197

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 197
---
, 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.

The European Commission may
also grant a so-called “conditional marketing authorization” prior to obtaining the comprehensive clinical data required for
an application for a full marketing authorization. Such conditional marketing authorizations may be granted for product candidates (including
medicines designated as orphan medicinal products), if (i) the risk-benefit balance of the product candidate is positive, (ii) it is likely
that the applicant will be in a position to provide the required comprehensive clinical trial data, (iii) the product fulfills an unmet
medical need and (iv) the benefit to public health of the immediate availability on the market of the medicinal product concerned outweighs
the risk inherent in the fact that additional data are still required. A conditional marketing authorization may contain specific obligations
to be fulfilled by the marketing authorization holder, including obligations with respect to the completion of ongoing or new studies,
and with respect to the collection of pharmac