Company: RDPTF
Filing Date: 2025-09-18
Form Type: 20-F
Source: 0001213900-25-088699
Chunk: 78

Company: Radiopharm Theranostics Ltd
Filing Date: 2025-09-18
Form: 20-F
Item: Item 3
Chunk 78
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 compliance with
the EMA’s cGMP requirements and comparable requirements of other regulatory bodies in the European Union, which mandate the methods,
facilities and controls used in manufacturing, processing and packing of products to assure their safety and identity.

Finally, the marketing
and promotion of authorized products, including industry-sponsored continuing medical education and advertising directed toward the
prescribers of products, are strictly regulated in the European Union under Directive 2001/83/EC, as amended. The advertising of
prescription-only medicines to the general public is not permitted in the European Union, or in the UK under the Human Medicines
Regulations 2021. Although general requirements for advertising and promotion of medicinal products are established under EU
Directive 2001/83/EC as amended, the details are governed by regulations in each European Union member state (as well as Iceland,
Norway and Liechtenstein) and can differ from one country to another.

United Kingdom

The United Kingdom (UK) left
the European Union in 2021 and will declare its independent processes to approve clinical research and marketing authorizations. Since
the regulatory framework in the UK covering quality, safety and efficacy of pharmaceutical products, clinical trials, marketing authorization,
commercial sales and distribution of pharmaceutical products is derived from EU Directives and Regulations, Brexit could materially impact
the future regulatory regime which applies to products and the approval of drug candidates in the UK, as UK legislation now has the potential
to diverge from EU legislation. It remains to be seen how Brexit will impact regulatory requirements for drug candidates and products
in the UK in the long-term. The MHRA has published detailed guidance for industry and organizations to follow from January 1, 2021, which
will be updated as the UK’s regulatory position on medicinal products evolves over time. How precisely clinical research within
the UK will be performed and how approval for drugs will be organized is subject to ongoing discussions.

The UK will no longer be covered
by centralized marketing authorizations (under the Northern Irish Protocol, centralized marketing authorizations will continue to be recognized
in Northern Ireland). All medicinal products with a current centralized marketing authorization were automatically converted to Great
Britain marketing authorizations on January 1, 2021. For a period of two years from January 1, 2021, the MHRA may rely on a decision taken
by the European Commission on the approval of a new marketing authorization in the centralized procedure, in order to more quickly grant
a new Great Britain marketing authorization.