Company: RVRC
Filing Date: 2025-12-12
Form Type: S-1/A
Source: 0001213900-25-121070
Chunk: 149

Company: Revium Rx.
Filing Date: 2025-12-12
Form: S-1/A
Chunk 149
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 designation because, for example, the product is sufficiently profitable not to justify market exclusivity.
Orphan medicinal product designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval
process. Following the UK’s exit from the EU, the MHRA continues to apply the same orphan market exclusivity framework as the EU.

Periods of Authorization and Renewals

A marketing authorization is valid for five years,
in principle, and it may be renewed indefinitely after five years on the basis of a reevaluation of the risk-benefit balance by
the EMA, the 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.

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Much like the federal healthcare program anti-kickback