N De Mario & Mario Limited also provide Early Access Programs (EAP) which is compliant, ethical, and controlled access to investigational medicine outside the clinical trial space and before commercial launch.

We only offer this program if it has been requested by a doctor or a physician for their clients with life-threatening diseases having no other treatment options available. There are several chronic, debilitating conditions that fall into the criteria of having access to EAP’s.

The process of providing this program takes early planning months prior to expected demand to decide whether an EAP should be implemented. Medicines with a positive scientific opinion could be made available to patients 12 to 18 months before formal marketing authorisation.

We consider all implications with physicians before deciding to begin the program by deliberating a plan so that the benefits outweigh the risks. A solid understanding of the process and potential barriers involved is crucial alongside knowledge of local regulations across different countries.

If faced with these unfortunate circumstances, please speak to your physician or healthcare professional and ask them to contact us so that we can discuss the appropriate options which are available.


To discuss Early Access Programs, please contact +44 (0) 208 732 5427

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