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7. Types of Marketing Authorisation Applications

1. 7 Types of Marketing Authorisation Applications

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There is not simply one type of marketing authorisation application in Europe, the list below shows what types of application are available. 

Types of applications for a Marketing Authorisation of a medicine

  • Full (Stand-alone) application
  • Generic application
  • Hybrid application
  • Similar biological product (biosimilar) application
  • Well established use application
  • Fixed combination application
  • ‘Informed consent’ application
  • Mixed application

Legal basis: Articles 8(3) and 10, 10a, 10b, or 10c of Directive 2001/83 (EC) and Article 6 of Regulation (EC) 726/2004