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Glossary

Company Core Safety Information (CCSI)

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All relevant safety information contained in the company core data sheet prepared by the Marketing Authorization Holder and which the Marketing Authorization Holder requires to be listed in all countries where the company markets the product, except when the local regulatory authority specifically requires a modification. 

Other glossary definitions

E

European Union (EU) Legal Representative

Sponsors who are not based in the EU/EEA must appoint a legal representative based in…

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P

Pre-Market Notification (510(k))

The US Food and Drug Administration (FDA) requires a 510(k) for moderate-risk Class II medical…

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