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Glossary

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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

C

Comparative Effectiveness Analysis (CEA)

A systematic evaluation of the evidence on the outcomes of different drugs or other options…

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C

Critical Quality Attribute (CQA)

A physical, chemical, biological or microbiological property or characteristic that should be within an appropriate…

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