Company: RDPTF
Filing Date: 2025-09-18
Form Type: 20-F
Source: 0001213900-25-088699
Chunk: 77

Company: Radiopharm Theranostics Ltd
Filing Date: 2025-09-18
Form: 20-F
Item: Item 3
Chunk 77
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 trials.

Periods of Authorization and Renewals

A marketing authorization
is valid for five years, in principle, and it may be renewed after five years on the basis of a re-evaluation of the risk benefit balance
by the EMA or by the competent authority of the authorizing member state. To that end, the marketing authorization holder must provide
the EMA or the competent authority with a consolidated version of the file in respect of quality, safety and efficacy, including all variations
introduced since the marketing authorization was granted, at least nine months before the marketing authorization ceases to be valid.
Once renewed, the marketing authorization is valid for an unlimited period, unless the European Commission or the competent authority
decides, on justified grounds relating to pharmacovigilance, to proceed with one additional five-year renewal period. Any authorization
that is not followed by the placement of the product on the EEA market (in the case of the centralized procedure) or on the market of
the authorizing member state within three years after authorization ceases to be valid.

Regulatory Requirements After Marketing Authorization

Following approval, the holder
of the marketing authorization is required to comply with a range of requirements applicable to the manufacturing, marketing, promotion
and sale of the medicinal product.

These include compliance with
the European Union’s stringent pharmacovigilance or safety reporting rules, pursuant to which post-authorization studies and additional
monitoring obligations can be imposed. The holder of a marketing authorization must establish and maintain a pharmacovigilance system
and appoint an individual qualified person for pharmacovigilance, who is responsible for oversight of that system. Key obligations include
expedited reporting of suspected serious adverse reactions and submission of periodic safety update reports, or PSURs.

In addition, all new MAAs
must include a risk management plan, or RMP, describing the risk management system that the company will put in place and documenting
measures to prevent or minimize the risks associated with the product. The regulatory authorities may also impose specific obligations
as a condition of the marketing authorization. Such risk-minimization measures or post-authorization obligations may include additional
safety monitoring, more frequent submission of PSURs, or the conduct of additional clinical trials or post-authorization safety studies.
RMPs and PSURs are routinely available to third parties requesting access, subject to limited redactions.

Furthermore, the manufacturing
of authorized products, for which a separate manufacturer’s license is mandatory, must also be conducted in strict