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Information for International Pharma Companies

Register sales in Europe with FDA approved medicines, without having a current EU license

 

There is an exemption within EU legislation that permits the supply of unlicensed medicines under specific circumstances. Such medicines have also been called Named Patient medicines, Unlicensed medicines, Unauthorised medicines, Specials, Pre-Approval, Off- Protocol or Off-Label medicines. Exempt Medicinal Product is the most accurate and up to date terminology for the majority of these medicines.

The exempt medicinal program differs from a formal compassionate use program which is a mechanism for getting an unapproved but promising new treatment to patients who would otherwise be unable to receive it. 

European sales revenues can be generated from FDA approved products ahead of the formal licensing process in Europe. 

 

Medisource are specialists in providing exempt medicines onto European markets.

• Medisource are fully GDP compliant and can sell your FDA approved product onto European markets within the restrictive legislative framework.
• We can supply the EU market with your product without any overlabelling or administrative input from your company.
• Medisource provide a Pharmacovigilance service to keep the company fully informed of any events that arise.
• Valuable marketing and safety information collected by Medisource during the supply of your product on an exempt medicine basis can be reported back to the company to assist in decision making in relation to European licensing strategy.

 

Further information on Medisource pharmaceutical supplies.