Section: Lesson 1: Product Information Regulation | Product information and information to the public | EUPATI Open Classroom

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Section outline

Learning outcomes of this lesson:

Describe the components of product information and access to information they contain

Outline the legal mandate and review process of product information
- Select activity 1. Introduction
  
  1. Introduction Page
  
  Learners must
  
  View
- Select activity 2. Summary of Product Characteristics (SmPC)
  
  2. Summary of Product Characteristics (SmPC) Book
  
  Learners must
  
  View
- Select activity 3. Package Leaflet (PL)
  
  3. Package Leaflet (PL) Book
  
  Learners must
  
  View
- Select activity 4. Package labelling
  
  4. Package labelling Book
  
  Learners must
  
  View
- Select activity 5. European Public Assessment Report (EPAR)
  
  5. European Public Assessment Report (EPAR) Book
  
  Learners must
  
  View
- Select activity 6. National registers of authorised medicines
  
  6. National registers of authorised medicines Page
  
  Learners must
  
  View
- Select activity 7. Patients’ involvement in product information
  
  7. Patients’ involvement in product information Page
  
  Learners must
  
  View
- Select activity 8. What EMA publishes and when
  
  8. What EMA publishes and when Page
  
  Learners must
  
  View
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