Company: RVRC
Filing Date: 2025-10-03
Form Type: S-1/A
Source: 0001213900-25-096094
Chunk: 146

Company: Revium Rx.
Filing Date: 2025-10-03
Form: S-1/A
Chunk 146
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 national competent authority (from the reporting EU member state selected by the applicant)
takes the lead in validating and evaluating the application, as well as consulting and coordinating with the other concerned member states
in which the clinical trial is to be conducted. If an application is rejected, it may be amended and resubmitted through CTIS. A concerned
member state may in limited circumstances declare an “opt-out” from an approval and prevent the clinical trial from being
conducted in that member state. As of January 31, 2025, all ongoing trials approved under the CTD must comply with the CTR and information
relating to such clinical trials must be recorded in CTIS. The CTR aims to streamline and simplify the rules on safety reporting, and
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