Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 196

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 196
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. For products with a new active substance indicated for the treatment of other diseases and products that
are highly innovative or for which a centralized process is in the interest of patients, the centralized procedure may be optional. The
centralized procedure may at the request of the applicant also be used in certain other cases.

Under the centralized procedure,
the CHMP is also responsible for several post-authorization and maintenance activities, such as the assessment of modifications or extensions
to an existing marketing authorization. Under the centralized procedure in the European Union., the maximum timeframe for the evaluation
of an MAA is 210 days, excluding clock stops, when additional information or written or oral explanation is to be provided by the
applicant in response to questions of the CHMP. Accelerated evaluation might be granted by the CHMP in exceptional cases, when a medicinal
product is of major interest from the point of view of public health and in particular from the viewpoint of therapeutic innovation. If
the CHMP accepts such request, the time limit of 210 days will be reduced to 150 days, but it is possible that the CHMP can revert to
the standard time limit for the centralized procedure if it considers that it is no longer appropriate to conduct an accelerated assessment.
At the end of this period, the CHMP provides a scientific opinion on whether or not a marketing authorization should be granted in relation
to a medicinal product. Within 15 calendar days of receipt of a final opinion from the CHMP, the European Commission must prepare a draft
decision concerning an application for marketing authorization. This draft decision must take the opinion and any relevant provisions
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