Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 205

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 205
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 companion diagnostic is necessary for correct use of the product |

United Kingdom medicines legislation
is subject to future regulatory change under the Medicines and Medical Devices Act 2021. This act sets out a new framework for the adoption
of medicines regulation.

Different rules apply in Northern
Ireland following implementation of the Northern Ireland Protocol, under which European Union central marketing applications continue
to apply there. However, in March 2023, the United Kingdom government and the European Commission reached agreement on a regulatory
framework to replace the Northern Ireland Protocol, referred to as the Windsor Framework. The Windsor Framework is expected to apply as
of January 1, 2025 and will change the existing system under the Northern Ireland Protocol, including the regulation of pharmaceutical
products in the UK. Specifically, the MHRA will be responsible for approving all medicines intended to be marketed in the UK (i.e., Great
Britain and Northern Ireland), while the EMA will no longer be involved in approving medicines intended for sale in Northern Ireland.

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The Trade and Cooperation Agreement, which sets
forth a framework for partnership between the European Union and the United Kingdom, became effective as of January 1, 2021. The
Trade and Cooperation Agreement between the European Union and the United Kingdom contains an Annex in relation to medicinal products
with the objective of facilitating availability of medicines, promotion of public health and consumer protection in respect of medicinal
products. The Annex provides for mutual recognition of good manufacturing practice (GMP) inspections and certificates, meaning that manufacturing
facilities do not need to undergo duplicate inspections for the two markets. The Annex establishes a Working Group on Medicinal Products
to deal with matters under the Trade and Cooperation Agreement, facilitate co-operation and for the carrying out of technical discussions.
It is expected that further bilateral discussions will continue with respect to regulatory areas not the subject of the Trade and Cooperation
Agreement, including pharmacovigilance. The Trade and Cooperation Agreement also does not include reciprocal arrangements for the recognition
of batch testing certification. However, the United Kingdom has listed approved countries, including the EEA which will enable UK importers
and wholesales to recognize certain certification and regulatory standards. The European Commission has not adopted such recognition procedures.

It is expected that the establishment of a separate
United Kingdom authorization system, albeit with transitional recognition procedures in the United Kingdom, will lead to additional regulatory
costs. In addition, additional regulatory costs may be incurred with respect to the lack of mutual recognition of batch testing and related
reg