Company: RVRC
Filing Date: 2025-10-03
Form Type: S-1/A
Source: 0001213900-25-096094
Chunk: 152

Company: Revium Rx.
Filing Date: 2025-10-03
Form: S-1/A
Chunk 152
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 competent authority of the authorizing member state, or the MHRA. To that end, the marketing authorization holder must provide
the EMA, the relevant national competent authority, or the MHRA with a consolidated version of the file in respect of quality, safety
and efficacy, including all variations introduced since the marketing authorization was granted, at least six months before the marketing
authorization expiry date. Once renewed, the marketing authorization is valid for an unlimited period, unless the European Commission,
the relevant national competent authority, or the MHRA decides, on justified grounds relating to pharmacovigilance, to proceed with one
additional five-year renewal period. Any marketing authorization ceases to be valid if it is not followed by the placement of the medicinal
product on the EU market (in the case of the centralized procedure), on the market of the authorizing member state (in the case of a national
procedure), or the UK market (as applicable), within three years after grant of such an authorization.

Regulatory Requirements After Marketing Authorization

Following approval, the holder of the marketing
authorization is required to comply with a range of requirements applicable to the manufacturing, marketing, promotion and sale of the
medicinal product, and must adhere in strict compliance with the applicable EU laws, regulations and guidance. These include compliance
with stringent pharmacovigilance rules, pursuant to which post-authorization studies and additional monitoring obligations can be imposed.
In addition, manufacture and control must also be conducted in strict compliance with cGMP requirements and comparable requirements of
other regulatory bodies in the EU and UK. cGMP requirements apply to the methods, facilities and controls used in manufacturing,
processing and packing of drugs against the quality standards appropriate to the intended use of a medicinal product and as required by
the marketing authorization, clinical trial authorization or product specification.

<div align='center'>95</div>

Much like the federal healthcare program anti-kickback
law in the United States, the provision of benefits or advantages to physicians to induce or encourage the prescription, recommendation,
endorsement, purchase, supply, order or use of medicinal products is also prohibited in the EU and the UK. The provision of benefits or
advantages to induce or reward improper performance generally is governed by the national anti-bribery laws of EU member states and the
Bribery Act 2010 in the UK. Infringement of these laws could result in substantial fines and imprisonment. Applicable law in Europe further
provides that, where medicinal products are