Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 143

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 143
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 for the centralized
procedure, it sends an application directly to the EMA, to be assessed by the Committee for Medicinal Products for Human Use (“CHMP”).
The CHMP is responsible for conducting the assessment of whether a medicine meets the required quality, safety, and efficacy requirements,
and whether the product has a positive risk/benefit profile. The time limit for the evaluation procedure 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). The
EMA then has fifteen days to forward its opinion to the European Commission, which will make a binding decision on the grant of an MA
within 67 days of the receipt of the CHMP opinion.

National marketing authorizations,
which are issued by the competent authorities of the Member States of the European Union 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 European Union, 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 various Member States through the decentralized procedure.

30

In the European Union, new
active substances (including both small molecules and biological medicinal products) approved on the basis of a complete and independent
data package qualify for eight years of data exclusivity upon marketing authorization and an additional two years of market exclusivity.
Data exclusivity prevents generic or biosimilar applicants from referencing the innovator’s preclinical and clinical trial data
contained in the dossier of the reference product when applying for a generic or biosimilar MA, for a period of eight years from the date
on which the reference product was first authorized in the European Union. During the additional two-year period of market exclusivity,
a generic or biosimilar MAA can be submitted, and the innovator’s data may be referenced, but no generic or biosimilar medicinal
product can be marketed until the expiration of the market exclusivity. The overall ten-year period will be extended to a maximum of eleven
years if, during the first eight years of those ten years, the MA holder obtains an authorization for one or more new therapeutic indications
which, during the scientific evaluation prior to authorization, is held to bring a significant clinical benefit in comparison with currently
approved therapies. There is no guarantee that a product will be considered