Euromed acts as a valuable bridge between MAHs and patients when they need medicines – most of times “life-saving” treatments for incurable pathologies – that cannot be available within the usual clinical or commercial setting.
- Patients need to continue the treatment, after the trials are completed, and be covered until its approval and commercialization (and Beyond) – (globally unlicensed);
- Patients from other countries require the therapy and cannot wait until the local marketing authorization is granted – (Under national registration);
- Patients necessitate the unlicensed medicine and cannot delay the treatment until (and if) the local supply is rescued – (On shortage);
Whether globally unlicensed, under national registration or on shortage we offer our full commitment to supply these medicines to hospitals, physicians and patients by helping MAHs through the hurdles of the process.
Early access programmes (EAPs) are also implemented for rare diseases. Patients with rare diseases are highly challenged by the availability and affordability of newly lunched and expensive treatments (Orphan drugs). For pharmaceutical companies developing orphan drugs, EAP is often the preferred option, instead of seeking a full-scale regulatory approval. Differences in national regulations about the implementation of EAPs pose a significant challenge to pharma companies.
That’s why you need us. The knowledge of available regulatory opportunities combined with the highest standards of compliance and ethics and supported by advanced logistic expertise makes Euromed your perfect and trusted partner.
Under these specific scenarios we offer specific supply solutions as:
- Dedicated import procedure activation under our own name
- Focal point with Hospitals and Physicians for ad-hoc medical requests
- Collection of required clearance and quality documents
- Customs Clearance management and product official release
- Outbound in-transit delivery to destination and Hospitals pre-alerting