Module 6

03/10/2024

Clause 11 Marketing Authorisation and Temporary Supply Authorisation

• Unlicensed medicines must not be promoted

• Promotion must be in accordance with marketing authorisation and must not be inconsistent with summary of product characteristics (SmPC)

• Some countries only allow promotion based on SmPC

• A medicine with a temporary supply authorisation must not be promoted unless it is part of a campaign that has been approved by the health ministers e.g. initial COVID-19 vaccines

Points to remember

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• Compassionate use, international conferences (UK attendees?), press releases of positive Opinions (but not yet MA)

The Organisation for Professionals in Regulatory Affairs

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Clause 11 Marketing Authorisation and Temporary Supply Authorisation

• Completed complaint case example (AUTH/3746/2/23)

The Organisation for Professionals in Regulatory Affairs

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