OUR SERVICES
UNLICENSED MEDICINE SUPPLY
Unlicensed medicines are pharmaceutical products that are not available for routine commercial distribution in a specific country. This may occur because regulatory approval is still pending, the product is authorised elsewhere but not locally, or it is supplied under defined early access or exceptional use frameworks.
The use of unlicensed medicines does not imply a lack of quality, safety or clinical value, but reflects differences in regulatory status, market availability or timing across jurisdictions.
We support manufacturers and healthcare systems in facilitating access to medicines prior to local marketing authorisation. This includes supply under early access and named patient frameworks, enabling timely treatment while regulatory and commercial processes are still ongoing.
Where shortages of licensed medicines impact patient care, we coordinate alternative sourcing solutions through compliant unlicensed supply routes. Our focus is on maintaining treatment continuity while aligning with national regulatory requirements and hospital pharmacy protocols.
For medicines that are discontinued, withdrawn or no longer commercially supplied in certain markets, we assist in securing ongoing access where clinical need persists. This supports long-term patients who depend on established therapies that may no longer be available through standard channels.
Across all unlicensed supply activities, Unipharma manages sourcing, documentation, logistics and coordination with authorised partners to ensure traceability, quality oversight and regulatory accountability. Each supply pathway is assessed individually to align with local requirements and clinical context.
Our approach to unlicensed medicine supply is grounded in controlled execution rather than volume trading. By combining regulatory awareness, operational discipline and international reach, we help healthcare systems and partners address access challenges across the full product lifecycle.
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