Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 3451

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 3451
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 of evaluation of a MA application 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 within 67 days of receipt of the EMA’s
    recommendation. Accelerated assessment might be granted by the CHMP in exceptional cases, when a medicinal product is expected to
    be of a major public health interest, particularly from the point of view of therapeutic innovation. The timeframe for the evaluation
    of a MA application under the accelerated assessment procedure is of 150 days, excluding stop-clocks, but it is possible that the
    CHMP may revert to the standard time limit for the centralized procedure if it determines that the application is no longer appropriate
    to conduct an accelerated assessment.

    ●
    National
    MAs, which are issued by the 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 product has already been authorized
    for marketing in a Member State of the EEA, this national MA can be recognized in other Member States through the mutual recognition
    procedure. If the product has not received a national MA in any Member State at the time of application, it can be approved simultaneously
    in various Member States through the decentralized procedure. Under the decentralized procedure an identical dossier is submitted
    to the competent authorities of each of the Member States in which the MA is sought, one of which is selected by the applicant as
    the Reference Member State, or RMS. The competent authority of the RMS prepares a draft assessment report, a draft summary of the
    product characteristics, or SmPC, and a draft of the labeling and package leaflet, which are sent to the other Member States (referred
    to as the Concerned Member States, or CMSs) for their approval. If the CMSs raise no objections, based on a potential serious risk
    to public health, to the assessment, SmPC, labeling, or packaging proposed by the RMS, the product is subsequently granted a national
    MA in all the Member States (i.e., in the RMS and the CMSs).

Under
the above described procedures, before granting the MA, the EMA or the competent authorities of the Member States of the EEA make an
assessment of the risk-benefit balance of