Named Patient Program
Managed Access Program (MAP) enables physicians and patients to access effective medications that are not yet commercially available on the local market. Regulations in the CIS allow patient to access unregistered drugs that are approved outside of the country upon requests made by physicians on behalf of individuals or “named” patients. Such prelaunch access is governed by specific criteria, collection of safety data, and control of the drug distribution.
Being the only registered operator of personal data in our geographies, COREX successfully manages the full cycle of access programs, from import license submission to customs clearance and distribution. Local project managers coordinate the entire process with the sponsoring company, including representatives from medical affairs, pharmaceutical development, regulatory, supply chain, business development and finance departments.
corex process approach
- 1 PROCUREMENT OF THE DRUG Exclusive procurement through direct contracts with manufacturers.
- 2 COLLECTION OF THE DOCUMENTS Collection of prescription data, Local Ethics Committee (LEC) approval and documents submission to the Ministry of Health (MoH).
- 3 APPROVALS AND IMPORT LICENSES Obtaining necessary permissions for importation of unregistered drugs.
- 4 CUSTOMS CLEARANCE Expedited customs inspection and release.
- 5 TEMPERATURE CONTROLLED DELIVERY Expedited delivery to the Institution in appropriate temperature regimes.