Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 38

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 38
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 of products, operating restrictions and criminal prosecution.

For
instance, in the European Economic Area (the “EEA”) (comprising the 27 European Union member states plus Iceland,
Liechtenstein and Norway), medicinal products must be authorized for marketing by using either the centralized authorization procedure
or national authorization procedures.

    ●
    Centralized procedure—The
    centralized procedure provides for the grant of a single marketing authorization by the European Commission that is valid
    throughout the EEA. Pursuant to Regulation (EC) No. 726/2004, the centralized procedure is compulsory for specific products,
    including for medicines produced by certain biotechnological processes, products designated as orphan medicinal products,
    advanced therapy products (gene therapy, somatic cell therapy and tissue engineered products) and products with a new active
    substance indicated for the treatment of certain diseases, which includes products for the treatment of cancer. For medicines
    that do not fall within one of the mandatory categories, an applicant still has the option of submitting an application for
    a centralized marketing authorization to the European Medicines Agency (the “EMA”), as long as the medicine concerned
    contains a new active substance not authorized in the EEA prior to May 20, 2004, is a significant therapeutic, scientific
    or technical innovation, or if its authorization would be in the interest of public health in the EEA. If pursuing marketing
    authorization for one of our compounds for a therapeutic indication under the centralized procedure, the EMA’s Committee
    for Medicinal Products for Human Use (the “CHMP”), is responsible for conducting an initial assessment of whether
    a product meets the required quality, safety and efficacy requirements, and whether a product has a positive benefit/risk
    ratio. Under the centralized procedure the maximum timeframe for the evaluation of a marketing authorization application (the
    “MAA”), 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 MAA considerably
    beyond 210 days. Where the CHMP gives a positive opinion, it 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