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Glossary

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.

Other glossary definitions

P

Periodic Safety Update Report (PSUR)

The PSUR provides an evaluation of the risk-benefit balance of a medicinal product defined time…

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E

Expedited Criteria

Criteria that should be fulfilled for expedited reporting. The four minimum information required for expedited…

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