Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 193

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 193
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 European Union Member States in which an application for authorization of a clinical trial
has been submitted (Concerned Member States). Part II is assessed separately by each Concerned Member State. Strict deadlines have been
established for the assessment of clinical trial applications. The role of the relevant ethics committees in the assessment procedure
will continue to be governed by the national law of the Concerned Member State. However, overall related timelines will be defined by
the Clinical Trials Regulation.

As in the United States, similar
requirements for posting clinical trial information are present in the European Union (EudraCT) website: https://eudract.ema.europa.eu/
and other countries.

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PRIME Designation in the European Union

In March 2016, the EMA launched
an initiative to facilitate development of product candidates in indications, often rare, for which few or no therapies currently exist.
The PRIority MEdicines, or PRIME, scheme is intended to encourage drug development in areas of unmet medical need and provides accelerated
assessment of products representing substantial innovation reviewed under the centralized procedure. Products from small- and medium-sized
enterprises, or SMEs, may qualify for earlier entry into the PRIME scheme than larger companies. Many benefits accrue to sponsors of product
candidates with PRIME designation, including but not limited to, early and proactive regulatory dialogue with the EMA, frequent discussions
on clinical trial designs and other development program elements, and accelerated marketing authorization application assessment once
a dossier has been submitted. Importantly, a dedicated Agency contact and rapporteur from the Committee for Human Medicinal Products,
or CHMP, or Committee for Advanced Therapies, or CAT, are appointed early in PRIME scheme facilitating increased understanding of the
product at EMA’s Committee level. A kick-off meeting initiates these relationships and includes a team of multidisciplinary experts
at the EMA to provide guidance on the overall development and regulatory strategies.

Marketing Authorization

To obtain a marketing authorization
for a product under European Union regulatory systems, an applicant must submit an MAA either under a centralized procedure administered
by the EMA, or one of the procedures administered by competent authorities in the European Union Member States (decentralized procedure,
national procedure or mutual recognition procedure). A marketing authorization may be granted only to an applicant established in the
European Union. Regulation (EC) No 1901/2006 provides that prior to obtaining a marketing authorization in the European Union, applicants
have