Company: RDPTF
Filing Date: 2025-09-18
Form Type: 20-F
Source: 0001213900-25-088699
Chunk: 73

Company: Radiopharm Theranostics Ltd
Filing Date: 2025-09-18
Form: 20-F
Item: Item 3
Chunk 73
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EC on GCP, a system for the approval of clinical
trials in the European Union has been implemented through national legislation of the member states. Under this system, an applicant
must obtain approval from the national competent authority, or NCA, of a European Union member state in which the clinical trial is
to be conducted or in multiple member states if the clinical trial is to be conducted in a number of member states. Furthermore, the
applicant may only start a clinical trial at a specific study site after the independent ethics committee, or EC, has issued a
favorable opinion in relation to the clinical trial. The clinical trial application must be accompanied by an investigational
medicinal product dossier with supporting information prescribed by Directive 2001/20/EC and Directive 2005/28/EC and corresponding
national laws of the member states and further detailed in applicable guidance documents. Under the current regime all suspected
unexpected serious adverse reactions to the investigated drug that occur during the clinical trial have to be reported to the NCA
and ECs of the member state where they occurred.

In April 2014, the European
Union adopted a new Clinical Trials Regulation (EU) No 536/2014, which is set to replace the current Clinical Trials Directive 2001/20/EC.
It will overhaul the current system of approvals for clinical trials in the European Union. Specifically, the new legislation, which will
be directly applicable in all EU member states (meaning that no national implementing legislation in each European Union member state
is required), aims at simplifying and streamlining the approval of clinical trials in the European Union. For instance, the new Clinical
Trials Regulation provides for a streamlined application procedure via a single-entry point and strictly defined deadlines for the assessment
of clinical trial applications. The new Clinical Trials Regulation became effective on January 31, 2022.

Marketing Authorization

To obtain a marketing authorization
for a product in the European Economic Area (comprised of the EU member states plus Norway, Iceland and Liechtenstein), or EEA, an
applicant must submit a MAA, either under a centralized procedure administered by the EMA or one of the procedures administered by competent
authorities in the EEA member states (decentralized procedure, national procedure, or mutual recognition procedure). A marketing authorization
may be granted only to an applicant established in the EEA.

The centralized procedure
provides for the grant of a single marketing authorization by the European Commission that is valid throughout the