Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 199

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 199
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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
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