Regulatory Compliance: How to accelerate your medicinal product launch in Europe

April 28, 2021
  • Launch Regulatory Compliance

Our experts at BlueReg are covering the different pathways to accelerate your medicinal product launch in Europe.

The different subjects covered are :

1. Regulatory Strategy – How to prepare the regultory launch sequence for your first medicinal product in Europe?

  • EU Marketing Authorisation (MA)
  • Regulatory Strategy Considerations
  • How to Plan the Regulatory Activities of your Medicinal Product Launch?
  • Planning of Activities for Local Market Launch is Crucial

2. Compliance with Regulatory Requirements

  • European Definition
  • Brexit Impact
  • Key Requirements to Launch a Product in the EU
  • Local Representatives
  • National Codes
  • Blue Box
  • Serialisation
  • Local Databases
  • Local Launch Date Notification
  • Promotional Materials
  • Educational Materials
  • Local Wholesale Distribution Authorization (WDA)
  • Shared Pack and Stock Keeping Unit (SKUs)

3. A tailored outsourcing regulatory platform

  • Outsourcing Platform to Support EU Local Market Launch

4. Q&A’s


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