Hybrid or Mixed Marketing Authorisation Application in the European Union

Communication Marketing
Regulatory affairs Pharmaceutical industry
Regulatory affairs Pharmaceutical industry
March 31, 2022
  • Drug Registration
  • Lifecycle Management
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In this white paper you will learn:

 

  • Basic EU legislation for medicinal products
  • Legal basis of the application in the EU
  • Hybrid applications
  • How to present your Hybrid application
  • Timetable for Hybrid applications under Article 10(3) of Directive 2001/83/EC
  • Post authorisation
  • Conclusion, Abbreviations & Bibliography

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