Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2556

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2556
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 or tissue-engineered medicines) and medicinal products containing a new active
    substance indicated for the treatment of HIV, AIDS, cancer, neurodegenerative disorders, diabetes, auto-immune and other immune dysfunctions
    and viral diseases. The centralized procedure is optional for products containing a new active substance not yet authorized in the
    EEA, or for products that constitute a significant therapeutic, scientific or technical innovation or which are in the interest of
    public health in the European Union. Under the centralized procedure the maximum timeframe for the evaluation of a MA application
    by the EMA is 210 days, excluding clock stops, when additional written or oral information is to be provided by the applicant in
    response to questions asked by the CHMP. Clock stops may extend the timeframe 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