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Access to unregistered drugs

Access to unregistered drugs

Health Logistics has in-depth expertise in running and organizing the patient access to the medications that are:

  • Registered in the third-country;
  • In the clinical trial phase in the third-country;
  • In pre-registration post trial phase;

Early Access Programs (EAP)

Compassionate Use Programs (CAP)

Named Patient Programs (NPP)

 Individual national  laws, may differ from one country to another, and some countries have more significant barriers to MAPs than others. Pharmaceutical manufacturers should always consider the degree of administrative effort required to initiate the program (eg, timing required to assess the application and patient volume restrictions), and the feasibility of establishing an initial price for the product through the EAP.

Health Logistics is assisting in getting through the complex regulatory process in a structured 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

MAP is an opportunity for the pharmaceutical manufactureres to establish the relationship with the physicians as early adopters of the novel treatment by forming a degree of good will with patient groups. This can be considered as an effecient way of market penetration and product launch, ultimately allowing more patients to benefit.