Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 198

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 198
---
ovigilance data. Conditional marketing authorizations are valid for one year, and may be
renewed annually, if the risk-benefit balance remains positive, and after an assessment of the need for additional or modified conditions
and/or specific obligations. The timelines for the centralized procedure described above also apply with respect to the review by the
CHMP of applications for a conditional marketing authorization.

The European Union medicines
rules expressly permit the European Union Member States to adopt national legislation prohibiting or restricting the sale, supply or use
of any medicinal product containing, consisting of or derived from a specific type of human or animal cell, such as embryonic stem cells.
While the products we have in development do not make use of embryonic stem cells, it is possible that the national laws in certain European
Union Member States may prohibit or restrict us from commercializing our products, even if they have been granted a European Union marketing
authorization.

Unlike the centralized authorization
procedure, the decentralized marketing authorization procedure requires a separate application to, and leads to separate approval by,
the competent authorities of each European Union Member State in which the product is to be marketed. This application is identical to
the application that would be submitted to the EMA for authorization through the centralized procedure. The reference European Union Member
State prepares a draft assessment and drafts of the related materials within 120 days after receipt of a valid application. The resulting
assessment report is submitted to the concerned European Union Member States who, within 90 days of receipt, must decide whether to approve
the assessment report and related materials. If a concerned European Union Member State cannot approve the assessment report and related
materials due to concerns relating to a potential serious risk to public health, disputed elements may be referred to the European Commission,
whose decision is binding on all European Union Member States.

The mutual recognition procedure
similarly is based on the acceptance by the competent authorities of the European Union Member States of the marketing authorization of
a medicinal product by the competent authorities of other European Union Member States. The holder of a national marketing authorization
may submit an application to the competent authority of a European Union Member State requesting that this authority recognize the marketing
authorization delivered by the competent authority of another European Union Member State.

In April 2023 the European
Commission issued a proposal that will revise and replace the existing general pharmaceutical legislation. If adopted and implemented
as currently proposed, these revisions will significantly change several aspects of drug development and approval in the European Union.

Regulatory Data Protection in the European Union