Definition

A communication sent directly to healthcare professionals to inform them of important safety information that may affect how they prescribe or use a medicine.

Example

A DHPC is sent to cardiologists informing them of a newly identified risk of QT prolongation, with recommendations for ECG monitoring and contraindicated combinations.

Regulatory source

EU GVP Module XV

Common mistakes

Sending DHPCs without regulatory agreement on content, or using inappropriate distribution channels.

Inspector question

Describe your DHPC development and approval process. How do you ensure appropriate distribution?

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