Company: RVRC
Filing Date: 2025-08-13
Form Type: S-1/A
Source: 0001213900-25-075747
Chunk: 143

Company: Revium Rx.
Filing Date: 2025-08-13
Form: S-1/A
Chunk 143
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 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
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 being promoted to persons qualified to prescribe or supply them, no gifts, pecuniary
advantages or benefits in kind may be supplied, offered or promised to such persons unless they are inexpensive and relevant to the practice
of medicine or pharmacy.

Pursuant to national laws, industry codes
or professional codes of conduct payments made to physicians in certain EU member states and the UK must be publicly disclosed. Moreover,
agreements with physicians often must be the subject of prior notification and approval by the physician’s employer, his or her
competent professional organization and/or the regulatory authorities of the individual EU member states, or the UK (as applicable).
Failure to comply with these requirements could result in reputational risk, public re