Medical Supply Distribution FAQs
What are exempt, unauthorised or unlicensed medicines?
Unlicensed medicines in any one country are products that have not been granted a marketing authorisation by that country's regulatory authorities. It does not mean that the product cannot be prescribed. In most cases such unauthorised medicinal products will have gone through a marketing authorisation process in another jurisdiction and may have an unauthorised status in your country simply because the product is pending assessment by your national authorisation body, or because the product manufacturer has not applied for marketing authorisation in your country. This unauthorised status is in no way a measure of a product’s safety or efficacy.
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, 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.
Further information on wholesale medical supplies in Ireland and across Europe.
We have movedEffective 1st November 2011 Medisource will operate from our new premises at Unit 24-26 Bullford Business Campus, Kilcoole, Co. Wicklow.
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