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Compassionate Use

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The use of an unauthorised medicine outside a clinical study in individual patients under strictly controlled conditions. This helps to make medicines that are still under development available to patients.

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Voluntary Harmonization Procedure (VHP)

When a sponsor wishes to carry out a clinical trial in two or more EU…

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Anonymization Report (AR)

Part of the Policy 70 submission package. It should describe the methodology of the anonymisation…

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