Module 18 2021

05/02/2021

EU Medicinal Competent Authorities

• MPA (Sweden) • DES Expertise

• Simple process and work to a timetable • Website recently updated and very detailed • Need advance Notification • Very good experience, especially in the pre-submission meetings

The Organisation for Professionals in Regulatory Affairs

21

EU Medicinal Competent Authorities

• MEB (The Netherlands) • Structured approach • Will give a timetable – but are unlikely to go faster

• Emphasis on actual clinical data • Good Relationship with the Team • Need advance notification

The Organisation for Professionals in Regulatory Affairs

22

11