Module 6

04/10/2024

Summary - Key PL/PIL Attributes

• A user-friendly document, consistent with the SmPC, designed to provide patients with essential information about a medicinal product, including its use, benefits, and risks.

Definition and Purpose

• Primarily aimed at patients and caregivers, ensuring they understand how to safely and effectively use the medication.

Target Audience

• Includes important data such as dosage instructions, potential side effects, and interactions with other medications, presented in clear and accessible language. • Required for regulatory compliance, the PIL must be approved as part of the MA alongside the product to ensure that patients receive accurate and necessary information. • Serves as a legal document that supports the safety and efficacy claims made by the manufacturer, protecting both the patient and the company. • Acts as a crucial resource for patients, enhancing their understanding of the medication and empowering them to engage actively in their healthcare decisions.

Content Detail

Regulatory Importance

Legal Importance

Communication Importance

The Organisation for Professionals in Regulatory Affairs

31

Educational materials for prescribers and patients

Educational materials extracted from eMC September 2024

The Organisation for Professionals in Regulatory Affairs

32

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