Company: SXTPW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003343
Chunk: 61

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 61
---

treatment of other diseases and products that are highly innovative or for which a centralized process is in the interest of patients,
the centralized procedure may be optional.

Under the centralized procedure, the Committee
for Medicinal Products for Human Use (the “CHMP”), established at the European Medicines Agency (“EMA”), is responsible
for conducting the initial assessment of a product. The CHMP is also responsible for several post-authorization and maintenance activities,
such as the assessment of modifications or extensions to an existing marketing authorization. Under the centralized procedure in the
European Union, the maximum timeframe for the evaluation of an MAA is 210 days, excluding clock stops, when additional information or
written or oral explanation is to be provided by the applicant in response to questions of the CHMP. Accelerated evaluation might be
granted by the CHMP in exceptional cases, when a medicinal product is of major interest from the point of view of public health and in
particular from the viewpoint of therapeutic innovation. In this circumstance, the EMA ensures that the opinion of the CHMP is given
within 150 days.

The decentralized procedure is available to applicants
who wish to market a product in various E.U. member states where such a product has not previously received marketing approval in any
E.U. member states. The decentralized procedure provides for approval by one or more other, or concerned, member states of an assessment
of an application performed by one member state designated by the applicant, known as the reference member state. Under this procedure,
an applicant submits an application based on identical dossiers and related materials, including a draft summary of product characteristics,
and draft labeling and package leaflet, to the reference member state and concerned member states. The reference member state prepares
a draft assessment report and drafts of the related materials within 210 days after receipt of a valid application. Within 90 days of
receiving the reference member state’s assessment report and related materials, each concerned member state must decide whether
to approve the assessment report and related materials.

If a member state cannot approve the assessment
report and related materials on the grounds of potential serious risk to public health, the disputed points are subject to a dispute
resolution mechanism and may eventually be referred to the European Commission, whose decision is binding on all member states.

31

Clinical Trial Approval 

Requirements for the conduct of clinical trials
in the European Union including Good Clinical Practice, are set forth in the Clinical Trials Directive 2001/20/EC and the GCP Directive