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Paediatric Investigation Plan (PIP)

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A paediatric investigation plan (PIP) is a development plan aimed at ensuring that the necessary data are obtained through studies in children, to support the authorisation of a medicine for children in Europe.

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Investigational New Drug (IND)

Administering an investigational drug to humans is subject to prior approval from regulatory authorities. Investigational…

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EXtended EudraVigilance Medicinal Product Dictionary (XEVMPD)

The submission of data on medicines by marketing-authorisation holders into the EVMPD is a legal…

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