Company: RVRC
Filing Date: 2025-10-03
Form Type: S-1/A
Source: 0001213900-25-096094
Chunk: 148

Company: Revium Rx.
Filing Date: 2025-10-03
Form: S-1/A
Chunk 148
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Passport designation and a Target Development Profile, and provides applicants with access to a toolkit to support all stages of the design,
development and approvals process. The major benefit of the ILAP scheme is that it provides applicants with opportunities for enhanced
regulatory and stakeholder input during the development of their medicinal products.

Marketing Authorization

To obtain a marketing authorization for a medicinal
product under the EU regulatory system, an applicant must submit an MAA, either under a centralized procedure administered by the EMA
or one of the procedures administered by competent authorities in EU member states (decentralized procedure, national procedure, or mutual
recognition procedure). A marketing authorization may be granted only to an applicant established in the EU.

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Regulation (EC) No 1901/2006 provides that
prior to obtaining a marketing authorization in the EU, an applicant must demonstrate compliance with all measures included in an EMA-approved
Pediatric Investigation Plan (“PIP”), covering all subsets of the pediatric population, unless the EMA has granted a product-specific
waiver, class waiver or a deferral for one or more of the measures included in the PIP. The Pediatric Committee of the EMA (“PDCO”),
may grant deferrals for some medicines, allowing a company to delay development of the medicine for children until there is enough information
to demonstrate its effectiveness and safety in adults. The PDCO may also grant waivers when development of a medicine for children is
not needed or is not appropriate, such as for diseases that only affect the elderly population. An application for marketing authorization
or a variation or a variation or a line-extension which is accompanied by the pediatric clinical trials conducted in accordance with
the PIP (even where such results are negative) are eligible for a six months extension of their supplementary protection certificate.
In the case of orphan medicinal products, a two-year extension of the orphan market exclusivity may be available. This pediatric reward
is not automatically available and is subject to the EMA or the relevant national competent authorities confirming compliance with the
agreed PIP that may require an opinion to be given by the EMA’s Pediatric Committee.

The centralized procedure provides for the grant
of a single marketing authorization by the European Commission that is valid for all EU member states, as well as the additional member
states of the EEA (Norway, Iceland and Liechtenstein). The centralized procedure is optional for products containing a new active substance
which was not authorized in the EU on