This course introduces the Marketing Authorisation (MA) application form and the Electronic Application Form (eAF) used in pharmaceutical regulatory submissions. It provides a practical overview of the purpose and structure of MA applications within the European regulatory framework.
Participants will learn about the different types of MA applications, the key legal acts and guidelines applicable to MA preparation, and the formal requirements for completing the application form correctly and consistently.
The course also explains the required annexes, declarations, and supporting statements submitted with the application, together with the basic principles, structure, and use of the Electronic Application Form (eAF) in regulatory submissions.
