Company: RDPTF
Filing Date: 2025-09-18
Form Type: 20-F
Source: 0001213900-25-088699
Chunk: 74

Company: Radiopharm Theranostics Ltd
Filing Date: 2025-09-18
Form: 20-F
Item: Item 3
Chunk 74
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 EEA. For those products
for which the use of the centralized procedure is not mandatory, applicants may elect to use the centralized procedure where either the
product contains a new active substance indicated for the treatment of diseases other than those on the mandatory list, or where the applicant
can show that the product constitutes a significant therapeutic, scientific or technical innovation, or for which a centralized process
is in the interest of public health.

Under the centralized procedure,
the Committee for Medicinal Products for Human use, or the CHMP, which is the EMA’s committee that is responsible for human medicines,
established at the EMA is responsible for conducting the assessment of whether a medicine meets the required quality, safety and efficacy
requirements, and whether it has a positive risk/benefit/risk profile. Under the centralized procedure, the maximum timeframe for the
evaluation of a MAA is 210 days from the receipt of a valid MAA, 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. 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. Accelerated evaluation may 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. If the CHMP accepts such a request, the timeframe of 210 days for assessment will be reduced
to 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.

PRIME Scheme

EMA now offers a scheme
that is intended to reinforce early dialogue with, and regulatory support from, EMA in order to stimulate innovation, optimize
development and enable accelerated assessment of PRIority MEdicines, or PRIME. It is intended to build upon the scientific advice
scheme and accelerated assessment procedure offered by EMA. The scheme is voluntary and eligibility criteria must be met for a
medicine to qualify for PRIME.

The PRIME scheme is open to
medicines under development and for which the applicant intends to apply for an initial marketing authorization application through the
centralized procedure. Eligible products must target