Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 39

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 39
---

    a medicinal product is expected to be of major public health interest, particularly from the point of view of therapeutic
    innovation. The timeframe for the evaluation of a MAA under the accelerated assessment procedure is 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 the application is no longer appropriate to conduct an accelerated assessment.

    ●
    National authorization
    procedures—There are also two other possible routes to authorize products for therapeutic indications in several countries,
    which are available for products that fall outside the scope of the centralized procedure:

    ●
    Decentralized procedure—Using
    the decentralized procedure, an applicant may apply for simultaneous authorization in more than one EEA member state for a
    medicinal product that has not yet been authorized in any EEA member state and that does not fall within the mandatory scope
    of the centralized procedure.

    ●
    Mutual recognition
    procedure—In the mutual recognition procedure, a medicine is first authorized in one EEA member state, in accordance
    with the national procedures of that country. Following this, additional marketing authorizations can be sought from other
    EEA member states in a procedure whereby the countries concerned recognize the validity of the original, national marketing
    authorization.

In
both cases, as with the centralized procedure, the competent authorities of the EEA member states assess the risk-benefit balance
of the product on the basis of scientific criteria concerning its quality, safety and efficacy before granting the marketing authorization.

22 

In
the EEA, new products for therapeutic indications that are authorized for marketing (so called “references products”)
qualify for eight years of data exclusivity and an additional two years of market exclusivity upon marketing authorization. The
data exclusivity period prevents generic or biosimilar applicants from referencing the preclinical and clinical trial data contained
in the dossier of the reference product when applying for a generic or biosimilar marketing authorization in the EEA during a
period of eight years from the date on which the reference product was first authorized in the EEA. The additional two-year period
of market exclusivity period prevents a successful generic or biosimilar applicant from commercializing its product in the EEA
until ten years have elapsed from the initial authorization of the reference product in the European Union. The overall ten-year
period can be extended to a maximum of eleven years if, during the first eight years of those ten