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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

F

Field Safety Notice (FSN)

A communication to customers and/or users sent out by a manufacturer or its representative in…

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G

GDPR / General Data Protection Regulation

The General Data Protection Regulation 2016/679 or GDPR came into effect in 2018 and sets…

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