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Scientific Advice

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Advice given by a regulatory/ reimbursement authority to a manufacturer on appropriate tests and studies to be performed during product development/ application for product reimbursement, in order to avoid major objections being raised during evaluation of the marketing authorisation application/ reimbursement application.

Other glossary definitions


Paediatric Investigation Plan (PIP)

A paediatric investigation plan (PIP) is a development plan aimed at ensuring that the necessary…

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Somatic-Cell Therapy medicinal Products (sCTP)

These contain cells or tissues that have been manipulated to change their biological characteristics or…

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