Company: RVRC
Filing Date: 2025-08-13
Form Type: S-1/A
Source: 0001213900-25-075747
Chunk: 137

Company: Revium Rx.
Filing Date: 2025-08-13
Form: S-1/A
Chunk 137
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introduces enhanced transparency requirements such as mandatory submission of a summary of the clinical trial results to the CTIS.

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The UK formally left the EU on January 31,
2020, under the terms of the Agreement on the withdrawal of the UK of Great Britain and Northern Ireland from the EU and the European
Atomic Energy Community (the EU-UK Withdrawal Agreement). Despite this, EU law continued to apply in the UK until the expiry of the transition
period on 31 December 2020. Following the UK’s departure from the EU, the UK and the EU entered into a trade and cooperation
agreement (“TCA”), which includes specific provisions concerning pharmaceuticals (such as the mutual recognition of cGMP
inspections of manufacturing facilities for medicinal products and cGMP documents issued), but which does not provide for wholesale mutual
recognition of UK and EU pharmaceutical regulations. At the point that the transition period expired, the Northern Ireland Protocol,
which is contained in the EU-UK Withdrawal Agreement, took effect. The Northern Ireland Protocol makes certain provisions of EU law,
including several concerning medicinal products, applicable in Northern Ireland. This position has recently been revised via the Windsor
Framework. Under the Windsor Framework, from January 1, 2025, all new medicinal products for the UK market will be authorized by
the UK’s Medicines and Healthcare products Regulatory Agency (“MHRA”) (see further below).

In the UK, clinical trials of medicinal products
are primarily governed by the Medicines for Human Use (Clinical Trials) Regulations 2004, as amended (the UK Regulations). The UK
Regulations sought to implement the CTD while the UK was a member state of the EU. Since the CTR was not in force in the EU at the time
when the UK exited the EU, it was not retained in UK law on exit day under the terms of the European Union (Withdrawal) Act 2018. Following
a public consultation which was conducted in early 2022, the UK authorities are in the process of developing legislation which seeks
to improve and strengthen the clinical trials regulatory regime in the UK. The extent to which the regulation of clinical trials in the
UK will mirror the CTR is unknown at present.

Accelerated Assessment Pathways

The EU’s Priority Medicines (“PRIME”)
scheme is intended to encourage drug development in areas of unmet medical need and facilitates accelerated assessment of medicinal products
representing substantial innovation reviewed under