Spring Intro 2023

16/02/2023

Why Important?

Required to communicate safety profile updates via appropriate mechanisms: ● Submission of a variation to update the PI & RMP with/without DHPC

DHPC required:

DHPC may be useful:

• MA suspended, withdrawn, revoked with recall of product from market for safety reasons; • Important changes to PI (restriction of indication, new contraindication, change in dose, major warnings or precautions); • Restriction in availability which impacts product’s current use by patients and HCPs.

• Change risk/benefit , either new risk or new information impacting efficacy profile • Recommendations for treating or preventing adverse reactions ; • Details of an ongoing assessment of an important potential risk for which conclusions are not yet available

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Top Tips

• Consider the potential impact of an update to CDS/EU PI on EdTs and if a DHPC is required • Monitoring DHPC progress is really important – GVP inspections! • Robust tracking systems & oversight needed • Strict requirements and agreement needed on communication: content, format, implementation plan & dissemination method For Educational Material(s): • Should be completely separated from promotional activities and contact information of physicians or patients gathered through educational programmes should not be used for promotional activities • NCA assessment times vary widely. Average 60 days but can be up to 9 mths

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