Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 200

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 200
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 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 has been Obtained

In case an authorization for
a medicinal product in the European Union is obtained, the holder of the marketing authorization is required to comply with a range of
requirements applicable to the manufacturing, marketing, promotion and sale of medicinal products. These include:

| • | Compliance with the European Union’s stringent pharmacovigilance or safety reporting rules must      
 be ensured. These rules can impose post-authorization studies and additional monitoring obligations. |

| • | The manufacturing of authorized medicinal products, for which a separate manufacturer’s license                                                    
 is mandatory, must also be conducted in strict compliance with the applicable European Union laws, regulations and guidance, including             
 Directive 2001/83/EC, Directive 2003/94/EC, Regulation (EC) No 726/2004 and the European Commission Guidelines for Good Manufacturing              
 Practice. These requirements include compliance with European Union cGMP standards when manufacturing