Charity testing programs
Compassionate Use Programs (CUP) are providing access to the medicines in a pre-approval phase to a group of patients in a selected clinic or hospital which treats patients with a serious debilitating disease, or where patients whose disease is considered to be life-threatening and who cannot be treated satisfactorily by an authorized medicinal product receive care. In such programs products are provided to the patients on non-commercial basis.
Physicians also are not subjects of remuniration for taking part in a program, but have additional option to introduce to their patients to cure seriouse disease.
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
Not all of the countries have programs to allow cohorts of patients rather than individuals, to benefit from early access. Reach out to us for regulatory overview.