Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 196

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 196
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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 pharmacovigilance data. Conditional marketing authorizations are valid for one year, and may be
renewed annually, if the risk-benefit balance remains positive, and after an assessment of the need for additional or modified conditions
and/or specific obligations. The timelines for the centralized procedure described above also apply with respect to the review by the
CHMP of applications for a conditional marketing authorization.

The European Union medicines
rules expressly permit the European Union Member States to adopt national legislation prohibiting or restricting the sale, supply or use
of any medicinal product containing, consisting of or derived from a specific type of human or animal cell, such as embryonic stem cells.
While the products we have in development do not make use of embryonic stem cells, it is possible that the national laws in certain European
Union Member States may prohibit or restrict us from commercializing our products, even if they have been granted a European Union marketing
authorization.

Unlike the centralized authorization
procedure, the decentralized marketing authorization procedure requires a separate application to, and leads to separate approval by,
the competent authorities of each European Union Member State in which the product is to be marketed. This application is identical to
the application that would be submitted to the EMA for authorization through the centralized procedure. The reference European Union Member
State prepares a draft assessment and drafts of the related materials within 120 days after receipt of a valid application. The resulting
assessment report is submitted to the concerned European Union Member States who, within 90 days of receipt, must decide whether to approve
the assessment report and related materials. If a concerned European Union Member State