Module 6

03/10/2024

Clause 14 Information, Claims and Comparisons

• Comparisons permitted in promotional material provided they are:

• accurate

• medicines for the same need/purpose and relevant features are compared

• no confusion created between medicine and the comparator

• Point to remember • Many breach of code claims come from competitors who will scrutinise your materials

The Organisation for Professionals in Regulatory Affairs

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Clause 14 Information, Claims and Comparisons

• References must be given when referring to published studies

• References to data on file - relevant part of this data must be provided on request • No exaggerated or all-embracing claims – no use of superlatives (superior, best etc) unless can be substantiated as a clear fact

The Organisation for Professionals in Regulatory Affairs

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