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Glossary

Conditional Marketing Autorisation

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The approval of a medicine that address unmet medical needs of patients on the basis of less comprehensive data than normally required.

The available data must indicate that the medicine’s benefits outweigh its risks and the applicant should be in a position to provide the comprehensive clinical data in the future.

Other glossary definitions

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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G

Good Manufacturing Requirements (GMP)

Good Manufacturing Practice. This is a recognised standard for pharmaceutical processing and manufacture ensuring medicinal…

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