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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.

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C

Common Technical Document (CTD)

The structure and format of applications to be submitted to regulatory authorities in the USA,…

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N

Name Patient Use

Supply of a medicinal product which is excluded by a Member State from the provisions…

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