Company: RVRC
Filing Date: 2025-12-12
Form Type: S-1/A
Source: 0001213900-25-121070
Chunk: 143

Company: Revium Rx.
Filing Date: 2025-12-12
Form: S-1/A
Chunk 143
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 application must be accompanied by an investigational medicinal product dossier with
supporting information prescribed by the CTR and corresponding national laws of the member states. All suspected unexpected serious adverse
reactions to the investigational medicinal product that occur during the clinical trial have to be reported to the national competent
authorities and research ethics committees of the member state where they occurred.

Pursuant to the CTR, a sponsor must submit a
single application for a new clinical trial authorization through a centralized EU clinical trials portal called the Clinical Trials
Information System (“CTIS”). One 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