Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 194

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 194
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 to demonstrate compliance with all measures included in an EMA-approved Paediatric Investigation Plan, or PIP, covering all subsets
of the pediatric population, unless the EMA has granted (1) a product-specific waiver, (2) a class waiver or (3) a deferral for one or
more of the measures included in the PIP.

The centralized procedure provides for the grant
of a single marketing authorization by the European Commission that is valid across the European Economic Area (i.e., the European Union
as well as Iceland, Liechtenstein and Norway). Pursuant to Regulation (EC) No 726/2004, the centralized procedure is compulsory for specific
products, including for medicines produced by certain biotechnological processes, products designated as orphan medicinal products, advanced
therapy medicinal products and products with a new active substance indicated for the treatment of certain diseases, including products
for the treatment of cancer. 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