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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

e

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

Electronic or paper filing system which must contains all study documents and at least essential…

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P

Pharmaceutical Establishment License (PEL)

Whilst marketing approval is granted for a given product, the company applying for marketing license…

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