Module 3 2019

Working with the Regulators

Understand our remit…………………….

• The Marketing Authorisation Holder is responsible for the quality of the product.

• Regulators are NOT here to TELL you what to do! • Regulators ARE here to ADVISE* and HELP you.

* Scientific advice:

• formal scientific (CHMP and / or national) advice (fee payable)

• regulatory advice (no charge in the UK)

The Organisation for Professionals in Regulatory Affairs