Company: RVRC
Filing Date: 2025-10-03
Form Type: S-1/A
Source: 0001213900-25-096094
Chunk: 149

Company: Revium Rx.
Filing Date: 2025-10-03
Form: S-1/A
Chunk 149
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 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 marketing
in a member state of the EEA, this national authorization can be recognized in other member states through the mutual recognition procedure.
If the product has not received a national authorization in any member state at the time of application, it can be approved simultaneously
in two or more member states through the decentralized procedure.

Following its departure from the EU, the UK has
introduced changes to its national licensing procedures, including procedures to prioritize access to new medicines that will benefit
patients, ILAP (described above) and new routes of evaluation for novel products and biotechn