Basic principles of the self-regulatory codes

The basic principles of the regulatory codes are to ensure that promotion of medicines is conducted in an ethical manner and that any information is clear, accurate, balanced, fair and objective. 

Substantiation is the verification of claims or statements made in promotional materials. This verification is usually by citing references, which in most countries must be provided to healthcare professionals and sometimes to competitors when requested. 

In general terms, substantiation by referencing is required in promotion in the following circumstances  

It is not normally necessary to substantiate claims that are within the terms of the licence. The type of data allowed to substantiate statements varies from country to country. They are  

Published data, e.g. from journals in the public domain 

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