Company: RDPTF
Filing Date: 2025-09-18
Form Type: 20-F
Source: 0001213900-25-088699
Chunk: 71

Company: Radiopharm Theranostics Ltd
Filing Date: 2025-09-18
Form: 20-F
Item: Item 3
Chunk 71
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/20/EC)
and the laws and regulations of the EU Member States implementing them. These provisions require, among other things, that the prior authorization
of an Ethics Committee and the competent Member State authority is obtained before commencing the clinical trial. In April 2014, the European
Union passed the Clinical Trials Regulation (Regulation 536/2014), which will replace the current Clinical Trials Directive. To ensure
that the rules for clinical trials are identical throughout the European Union, the EU Clinical Trials Regulation was passed as a regulation
that is directly applicable in all EU member states. All clinical trials performed in the European Union are required to be conducted
in accordance with the Clinical Trials Directive until the Clinical Trials Regulation becomes applicable. According to the current plans
of the EMA, the Clinical Trials Regulation is expected to become applicable.

After we have completed our
clinical trials, we must obtain marketing authorization before we can market our product. We may submit applications for marketing authorizations
under a centralized procedure. The centralized procedure provides for the grant of a single marketing authorization that is valid for
all European Union member states.

The European Medicines Agency,
or EMA, is a body of the European Union located in Amsterdam. The EMA is responsible for the scientific evaluation of medicines developed
by pharmaceutical companies for use in the European Union. The EMA is involved in the scientific evaluation of medicines that fall within
the scope of the centralized procedure. Like the FDA there is a harmonization between regulators and the EMA may inspect and audit the
development facilities, planned production facilities, clinical trial sites and laboratory facilities. Additionally, after the product
is approved and marketed, the EMA uses different mechanisms for assuring that firms adhere to the terms and conditions of approval described
in the application and that the product is manufactured in a consistent and controlled manner. This is done by periodic unannounced inspections
of production and quality control facilities.

If any of our drug candidates
receive marketing approval in the EEA, we expect they will benefit from 8 years of data protection and 10 years of market protection.
The periods run in parallel so effectively 8 years of data protection plus 2 years of market protection is granted. This means that a
biosimilar application referencing our safety and efficacy data held on file at the EMA cannot be filed until the end of the data protection
period of 8 years, and the biosimilar cannot be placed on the market until after a further 2 years have elapsed (8 +