Module 3 Presentations

14/05/2024

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

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Scientific Advice EMA • Advice given by Committee for Medicinal Products for Human Use (CHMP) on the recommendation of the Scientific Advice Working Party (SAWP) • Advice is applicable throughout the EU • Requesting EMA advice does not preclude consultation with national authorities • May/may not involve a discussion meeting (with SAWP)

National (UK)

• Advice given by relevant team via a meeting and in writing after the meeting

The Organisation for Professionals in Regulatory Affairs

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