Unlicensed Medicines

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For more than 100 years, FarmaMondo provides to thousands of caregivers globally, the access to pharmaceuticals that are commercially unavailable in their home countries.

We offer named patient access to new therapies when launch is delayed, and cohorts’ access to established products to replace therapies undergoing supply shortages. We address global unmet patient needs by deploying our robust distribution infrastructure and by navigating through the complex regulatory environments for the supply of unlicensed medicines.

FarmaMondo’s business services for access to unlicensed medicines cover:

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STAGGERED LAUNCH OF INNOVATIVE PRODUCTS

While market access plans of research-based pharmaceutical companies may not cover all countries equally, their patient-centric approach should allow access for patients with unmet medical needs also in non-launched countries. It may take months or even years before treatments are approved for commercial supply in certain countries. But patients cannot wait. During this lag time, FarmaMondo responds to global HCPs requests to access such medicines, and supply them via national Named Patient regulatory routes in place. FarmaMondo establishes Managed Access Programs on behalf of innovators to capture and serve named patient requests for access in non-launched markets.

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SHORTAGES OF ESTABLISHED PRODUCTS

Medicine shortages are a growing and complex global challenge. Shortages of essential drugs are becoming increasingly frequent globally, burdening health systems with additional costs and posing risks to the health of patients who fail to receive the medicines they need. More than 85% of EU hospitals report medicine shortages as an acute problem. Commonly prescribed hospital medicines undergoing shortages have significant negative impacts on patient’s care. A hospital, facing medicine shortages without having a locally-available licensed- replacement therapy, can only find a solution by utilizing unlicensed medicine routes to source and import an alternative treatment commercially available in another country. FarmaMondo serves HealthCare Providers globally with safe and uninterrupted supply of alternative to those on shortage.

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MARKET EXIT AND PRODUCT DISCONTINUATION OF SUPPLY

Market exit of a drug is a valid strategic direction for biopharmaceutical companies. Therapy discontinuation could potentially result in an unmet medical need for those patients unable to find suitable replacement therapies. The solution for pharmaceutical manufacturers to mitigate such implications for patients, is to put in place a Managed Access Program allowing patients to have access to the required medicine beyond product discontinuation at an unlicensed status.

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