Importation on vital indications of access to unregistered drugs
Named Patient Programs include broad range of options for pre-approval access to drugs in response to requests by physicians on behalf of specific, or “named”, patients before those medicines are licensed in the patient’s home country:
- Medicinal Products Bypassing Clinical Research;
- Medicinal Products Registered in Third-Country;
- Medicinal Products Awaiting the Market Authorization;
NPPs are limited to the requested named patient only and have all the quotas of products prescribed per the particular subjects. These programs can be initiated by the physicians and may be a subject of reimbursement of health insurance.
Health Logistics is assisting in getting through the complex set of the regulatory in a simple straightforward way by guiding you the the process:
- Connecting our clients with physicians experienced in MAPs;
- Organizing handling of patient primary data in accordance with GDPR;
- Assisting physicians in obtaining the medcial council decision;
- Streamlining import licnese obtaining;
- Organizing importation and direct-to-patient delivery
Reach out to us for regulatory overview.