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Glossary

eTMF/ TMF: electronic Trial Master File / Trial Master File

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Electronic or paper filing system which must contains all study documents and at least essential documents as described in ICH E6.

Other glossary definitions

M

Market Exclusivity

The 10-year period after the marketing authorisation of an orphan medicine when similar medicines for…

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T

Tissue Engineered Product (TEP)

A human tissue-engineered product (hTEP) means any autologous or allogeneic product which: contains, consists of,…

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