Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 198

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 198
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has an initial validity for five years in principle. The marketing authorization may be renewed after five years on the basis of a re-evaluation
of the risk-benefit balance by the EMA or by the competent authority of the E.U. Member State. To this end, the marketing authorization
holder must provide the EMA or the competent authority with a consolidated version of the file in respect of quality, safety and efficacy,
including all variations introduced since the marketing authorization was granted, at least six months before the marketing authorization
ceases to be valid. The European Commission or the competent authorities of the E.U. Member States may decide, on justified grounds relating
to pharmacovigilance, to proceed with one further five-year period of marketing authorization. Once subsequently definitively renewed,
the marketing authorization shall be valid for an unlimited period. Any authorization which is not followed by the actual placing of the
medicinal product on the E.U. market (in case of centralized procedure) or on the market of the authorizing E.U. Member State within three
years after authorization ceases to be valid (the so-called sunset clause).

Pediatric Studies

Prior to obtaining a marketing
authorization in the European Union, applicants have 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 a product-specific waiver, a
class waiver, or a deferral for one or more of the measures included in the PIP. The respective requirements for all marketing authorization
procedures are set forth in Regulation (EC) No 1901/2006, which is referred to as the Paediatric Regulation. This requirement also applies
when a company wants to add a new indication, pharmaceutical form or route of administration for a medicine that is already authorized.
The Paediatric Committee of the EMA, or PDCO, may grant deferrals for some medicines, allowing a company to delay development of the medicine
in children until there is enough information to demonstrate its effectiveness and safety in adults. The PDCO may also grant waivers when
development of a medicine in children is not needed or is not appropriate, such as for diseases that only affect the elderly population.

Before a marketing authorization application can
be filed, or an existing marketing authorization can be amended, the EMA determines that companies actually comply with the agreed studies
and measures listed in each relevant PIP.

Regulatory Requirements after a Marketing Authorization