What is an Unlicensed Medicine?
An unlicensed medicine is a pharmaceutical product that has not yet received approval or formal authorization from the relevant regulatory authorities in a specific country. This does not mean that the medicine is unsafe or ineffective; rather, it has not been licensed for distribution in that particular market for reasons such as:
The medicine may still be awaiting regulatory approval in that country.
It may already be approved and licensed in another country but not in the one where it’s being requested.
The medicine may be part of an early access program or intended for use in a situation where no suitable alternative treatment exists.
In many cases, unlicensed medicines are crucial for patients with urgent or unmet medical needs, particularly in treating rare diseases or during shortages of licensed medicines.
At Unipharma, we work closely with healthcare providers and regulatory authorities to ensure these medicines are delivered safely and efficiently to patients who need them.
What is a specialty medicine?
Specialty drugs are high-cost prescription medications used to treat complex, chronic conditions like cancer, rheumatoid arthritis, and multiple sclerosis.
Specialty drugs sometimes require special handling and administration (typically injection or infusion), and patients using a specialty drug may need careful oversight from a health care provider who can watch for side effects and ensure that the medication is working as intended.
Many manufacturers, through the support of Unipharma, offer patient assistance programs to help people with and without insurance get access to specialty drugs.