Module 6

03/10/2024

Clause 3 Obligations

• Completed complaint case example (AUTH/2988/10/17)

The Organisation for Professionals in Regulatory Affairs

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Clause 6 Information, Claims, Comparisons and Disparagement

• Information, claims and comparisons must:

• be accurate, balanced, fair, objective and unambiguous, based on an up-to-date evaluation of all the evidence and must not mislead • be capable of substantiation and substantiation provided on request • when data from a clinical trial is used, companies must ensure that where necessary that trial has been registered and the results disclosed in accordance with Clause 4.6.

The Organisation for Professionals in Regulatory Affairs

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