Company: RVRC
Filing Date: 2025-08-13
Form Type: S-1/A
Source: 0001213900-25-075747
Chunk: 138

Company: Revium Rx.
Filing Date: 2025-08-13
Form: S-1/A
Chunk 138
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 the centralized procedure. Eligible products must target conditions for which there
is an unmet medical need (there is no satisfactory method of diagnosis, prevention or treatment in the EEA or, if there is, the new medicine
will bring a major therapeutic advantage) and they must demonstrate the potential to address the unmet medical need by, for example,
introducing new methods of therapy or improving existing ones. Products from small- and medium-sized enterprises may qualify for earlier
entry into the PRIME scheme. Many benefits accrue to sponsors of therapeutic candidates with PRIME designation, including but not limited
to, early and proactive regulatory dialogue with the EMA, frequent discussions on clinical trial designs and other development program
elements, and accelerated MAA assessment once a dossier has been submitted. Importantly, an EMA contact and rapporteur from the Committee
for Human Medicinal Products (“CHMP”), or Committee for Advanced Therapies are appointed early in the PRIME scheme facilitating
increased understanding of the product at the EMA’s Committee level. A kick-off meeting initiates these relationships and includes
a team of multidisciplinary experts at the EMA to provide guidance on the overall development and regulatory strategies. Where, during
the course of development, a medicine no longer meets the eligibility criteria, support under the PRIME scheme may be withdrawn.

The UK’s Innovative Licensing and Access
Pathway (“ILAP”) aims to accelerate the time to market of innovative medicinal products. It is open to both commercial and
non-commercial applicants, who are based in the UK or global, and who are developing medicinal products which include products containing
new chemical entities, biological medicinal products, new indications and repurposed medicinal products. It comprises of an Innovation
Passport designation and a Target Development Profile, and provides applicants with access to a toolkit to support all stages of the
design, development and approvals process. The major benefit of the ILAP scheme is that it provides applicants with opportunities for
enhanced regulatory and stakeholder input during the development of their medicinal products.

Marketing Authorization

To obtain a marketing authorization for a
medicinal product under the EU regulatory system, an applicant must submit an MAA, either under a centralized procedure administered
by the EMA or one of the procedures administered by competent authorities in EU member states (decentralized procedure, national procedure,
or mutual recognition procedure). A marketing authorization may be granted only to an applicant established in the EU.

Regulation (EC) No 1901/2006 provides