Module 6

04 October 2024

14 An Agency perspective: the success and failure of a medicinal product in the EU

Classified as public by the European Medicines Agency

14

Key considerations and issues during the development phase

Early dialogue

PRIME designation

Scientific Advices

Qualification

Paediatric Investigation Plan ‘PIPs’

Orphan designation

Applicant claims

Legal Basis

15

An Agency perspective: the success and failure of a medicinal product in the EU

Classified as public by the European Medicines Agency

15

8