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Glossary

EU Reference Date

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For medicinal products containing the same active substance or the same combination of active substances, the date of the first marketing authorization in the EU of a medicinal product containing that active substance or that combination of active substances; or if this date cannot be ascertained, the earliest of the known dates of the marketing authorizations for a medicinal product containing that active substance or that combination of active substances. 

Other glossary definitions

P

Protocol Assistance (PA)

Protocol assistance is the special form of scientific advice available for companies developing designated orphan…

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U

Unanticipated Serious Adverse Device Effect (USADE)

A Serious Adverse Device Effect which by its nature, incidence, severity, or outcome has not…

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