Module 6

04/10/2024

Educational materials for prescribers and patients

• Additional risk minimisation measures that are intended to promote the safe and effective use of the medicinal product • Legal basis for centralised procedure (Art 21 of Ref (EC) No726/2004 in conjunction with Art 104 of Dir 2001/83/EC as amended

• Outlined in the RMP

• Used when PRAC considers the safety of the medicine can be enhanced by providing supplementary materials, described in Annex II of product information • Focus on one or more specific safety concerns related to use of the medicinal product to provide clear information on these specific risks and describe concisely what actions are required to prevent and minimise such risks

• Intended for HCPs and or patients and caregivers

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Educational materials for prescribers and patients cont.

• Produced and Distributed by MAH and specific to that medicinal product

• Must be approved by local HAs even if centralised procedure

• Companies must have the resources available to be ready for national implementation of the Ed Mats within the timeframe allowed (review and assessment 60 days average according to GVP) • National target audience and dissemination plan, mock-ups of the materials may be required • Ed Mats must be available for product launch – incorporate timelines in launch plans

• For prescription only medicines, educational materials must not be promotional

The Organisation for Professionals in Regulatory Affairs

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