Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 197

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 197
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 cannot approve the assessment report and related
materials due to concerns relating to a potential serious risk to public health, disputed elements may be referred to the European Commission,
whose decision is binding on all European Union Member States.

The mutual recognition procedure
similarly is based on the acceptance by the competent authorities of the European Union Member States of the marketing authorization of
a medicinal product by the competent authorities of other European Union Member States. The holder of a national marketing authorization
may submit an application to the competent authority of a European Union Member State requesting that this authority recognize the marketing
authorization delivered by the competent authority of another European Union Member State.

In April 2023 the European
Commission issued a proposal that will revise and replace the existing general pharmaceutical legislation. If adopted and implemented
as currently proposed, these revisions will significantly change several aspects of drug development and approval in the European Union.

Regulatory Data Protection in the European Union

In the European Union, innovative
medicinal products approved on the basis of a complete independent data package qualify for eight years of data exclusivity upon marketing
authorization and an additional two years of market exclusivity pursuant to Directive 2001/83/EC. Regulation (EC) No 726/2004 repeats
this entitlement for medicinal products authorized in accordance to the centralized authorization procedure. Data exclusivity prevents
applicants for authorization of generics of these innovative products from referencing the innovator’s data to assess a generic
(abridged) application for a period of eight years. During an additional two-year period of market exclusivity, a generic marketing authorization
application can be submitted and authorized, and the innovator’s data may be referenced, but no generic medicinal product can be
placed on the European Union market until the expiration of the market exclusivity. The overall ten-year period will be extended to a
maximum of 11 years if, during the first eight years of those ten years, the marketing authorization holder obtains an authorization for
one or more new therapeutic indications which, during the scientific evaluation prior to their authorization, are held to bring a significant
clinical benefit in comparison with existing therapies. Even if a compound is considered to be a new chemical entity so that the innovator
gains the prescribed period of data exclusivity, another company nevertheless could also market another version of the product if such
company obtained marketing authorization based on an MAA with a complete independent data package of pharmaceutical tests, preclinical
tests and clinical trials.

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Periods of Authorization and Renewals

A marketing authorization