Company: RVRC
Filing Date: 2025-08-13
Form Type: S-1/A
Source: 0001213900-25-075747
Chunk: 142

Company: Revium Rx.
Filing Date: 2025-08-13
Form: S-1/A
Chunk 142
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 waivers, protocol assistance
(as a type of scientific advice specific for orphan medicinal products) and the possibility to apply for a centralized EU marketing authorization.
Marketing authorization for an orphan medicinal product benefits from a ten-year period of market exclusivity. During this period of
market exclusivity, the European Commission, national competent authorities of the EU member states may only grant marketing authorization
to a “similar medicinal product” for the same therapeutic indication if: (i) a second applicant can establish that its
medicinal product, although similar to the authorized product, is safer, more effective or otherwise clinically superior; (ii) the
marketing authorization holder for the authorized product consents to a second orphan medicinal product application; or (iii) the
marketing authorization holder for the authorized product cannot supply enough orphan medicinal product. A “similar medicinal product”
is defined as a medicinal product containing a similar active substance or substances as contained in an authorized orphan medicinal
product, and which is intended for the same therapeutic indication. The period of marketing protection for the authorized therapeutic
indication may, however, be reduced to six years if, at the end of the fifth year, it is established that the product no longer
meets the criteria for orphan drug 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