Module 18 2021

05/02/2021

EU Medicinal Competent Authorities

• HPRA (Ireland) • Structured approach • Will give a timetable • Good Relationship with the Team • Need advance notification

The Organisation for Professionals in Regulatory Affairs

23

EU Medicinal Competent Authorities

• The European Medicines Agency • Administration agency funded by fees plus Commission • Manages centralized MAs and European scientific advice • NB Consultations on blood products and some chemical molecules – guidance published on EMEA website • No Assessors – ‘contracts’ to Member States for assessment • Outcome of consultations is seen by all EU CAs • Expensive but SME can apply for a reduction in fees

The Organisation for Professionals in Regulatory Affairs

24

12