Company: RVRC
Filing Date: 2025-08-13
Form Type: S-1/A
Source: 0001213900-25-075747
Chunk: 140

Company: Revium Rx.
Filing Date: 2025-08-13
Form: S-1/A
Chunk 140
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 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 biotechnological products. Notwithstanding that
there is no wholesale recognition of EU pharmaceutical legislation under the TCA, and that EU marketing authorizations do not automatically
provide a valid basis for the commercialization of medicinal products in Great Britain from January 1, 2024, applicants will be
able to request the MHRA to recognize marketing authorizations granted in foreign jurisdictions (including the EU) under a new International
Recognition Procedure.

Patent Term Extensions in the EU and Other Jurisdictions

The EU also provides for patent term extension
through SPCs which aim to offset the loss of patent protection for pharmaceutical products arising from the lengthy testing and clinical
trials required to obtain an MA. The rules and requirements for obtaining a SPC are