Company: RVRC
Filing Date: 2025-12-12
Form Type: S-1/A
Source: 0001213900-25-121070
Chunk: 146

Company: Revium Rx.
Filing Date: 2025-12-12
Form: S-1/A
Chunk 146
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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 May 20, 2004, or for products that constitute a significant therapeutic, scientific or technical
innovation or which are in the interest of public health in the EU. An applicant for the centralized MA must demonstrate the quality,
safety and efficacy of their products to the EMA for an opinion to be adopted regarding the approvability of the MAA. The European Commission
grants or refuses marketing authorization in light of the opinion delivered by the EMA.

Under the centralized procedure, the CHMP established
within the EMA is responsible for conducting an initial assessment of a medicinal product. The maximum timeframe for the evaluation of
an MAA is 210 days, excluding clock stops when additional information or written or oral explanation is to be provided by the applicant
in response to questions of the CHMP. Clock stops may extend the timeframe of evaluation of an MAA considerably beyond 210 days.
Where the CHMP gives a positive opinion, the EMA provides the opinion together with supporting documentation to the European Commission,
who make the final decision to grant a marketing authorization, which is issued ordinarily within 67 days of receipt of the EMA’s
recommendation. Accelerated evaluation may be granted by the CHMP in exceptional cases, when a medicinal product is of major interest
from the point of view of public health and, in particular, from the viewpoint of therapeutic innovation. If the CHMP accepts such a
request, the time limit of 210 days will be reduced to 150 days (excluding clock stops), but it is possible that the CHMP may
revert to the standard time limit for the centralized procedure if it determines that it is no longer appropriate to conduct an accelerated
assessment.

National marketing authorizations, which are
issued by the national competent authorities of the member states of the EEA and only cover their respective territory, are available
for products not falling within the mandatory scope of the centralized procedure. Where a medicinal product has already been authorized
for