Company: RVRC
Filing Date: 2025-10-03
Form Type: S-1/A
Source: 0001213900-25-096094
Chunk: 151

Company: Revium Rx.
Filing Date: 2025-10-03
Form: S-1/A
Chunk 151
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 method exists, the drug will be of significant benefit to those affected by that condition.
In the UK, the MHRA conducts an equivalent assessment, against criteria which have been tailored for the UK population.

The COMP is required to re-assess the granted
orphan designation at the time of marketing authorization grant to ensure that it continues to meet the criteria for the designation to
be maintained. Otherwise, the orphan designation can be revoked. In relation to the UK, the MHRA does not grant orphan designations during
the development of the medicinal product. Instead, the MHRA will decide whether the criteria are satisfied at the point of marketing authorization
grant. An orphan drug designation provides a number of benefits, including fee reductions, fee 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