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2. Early access

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  3. Regulatory Affairs
  4. Regulatory procedures - Marketing-Authorisations and their lifecycle management
  5. 2. Early access
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2. Early access

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7. References

1. The EMA webpage on Compassionate Use http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000293.jsp&mid=WC0b01ac05809f843c

2. Taken from Questions and answers on the compassionate use of medicines in the European Union http://www.ema.europa.eu/docs/en_GB/document_library/Other/2010/01/WC500069898.pdf

3. HMA Subgroup on Timely Access
Mapping of national frameworks for Early Access Programmes

4. New Early Access and Off-Label Use Rules in France, Léna Beley et al., July 6, 2021, Posted in Compassionate Use, European Union, Healthcare system, Medicinal Products, Pharmaceutical companies

1. Introduction
3. Off-label use
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Table of contents
  • 1. Special procedures - recap
  • 2. Early access programmes (managed access)
    • 2.1. Access between regulatory approval and availability and patient access
  • 3. Compassionate use
    • 3.1. Applicable Medicines
    • 3.2. Initiation and oversight of compassionate use programmes
    • 3.3. Patient access
    • 3.4. The role of the European Medicines Agency
    • 3.5. Compassionate use versus clinical trials
  • 4. Named patient basis access
  • 5. EU Expanded access (programmes) (Clinical trials)
  • 6. Comparisons
  • 7. References
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    • Regulatory procedures - Marketing-Authorisations and their lifecycle management
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    Lesson 4: Use of medicines outside of or without a marketing authorisation
    2. Early access

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