1. 7 Types of Marketing Authorisation Applications

(This section is organised in the form of a book, please follow the blue arrows to navigate through the book or by following the navigation panel on the right side of the page.)

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