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Glossary

Name Patient Use

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Supply of a medicinal product which is excluded by a Member State from the provisions of Directive 2001/83/EC, in accordance with the legislation in force and to fulfill special needs, in response to a bona fide unsolicited order, formulated in accordance with the specifications of authorized healthcare professional and for use by an individual patient under his direct personal responsibility [based on DIR 2001/83/EC Art 5(1)]. 

Other glossary definitions

I

ISO 13485

ISO 13485 is a Quality Management System (QMS) standard designed specifically for medical devices, and…

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F

Food and Drug Administration (FDA or USFDA)

The FDA is a Federal agency within US Department of Health and Human Services, which…

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