The basic principles of promotion of medicines

You may create a wide variety of assets in your role, including non promotional and promotional material. In this training we are mainly focused on promotional material although we will also cover materials for patients and the public. Most the principles covered will also apply to non-promotional assets.

We will start by looking in some detail at the requirements for promotional claims. First here are a few basics to remind you of – click on each for more information.

Timing

No product can be promoted in a country before the marketing authorization is granted in that country.

 

Marketing Authorization

Promotional information and claims must be in line with the terms of the marketing authorization (i.e. information in the summary of product characteristics (SmPC) or US PI).

 

Safety

The word ‘safe’ must not be used in promotional material without qualification. It should not be stated that a product is ‘safe’ or has ‘proven safety’ etc.

 

Exaggerated claims

Avoid exaggerated descriptions, such as ‘the best’, the ‘strongest’ etc. – these can be difficult to substantiate

 

All embracing claims

Avoid ‘all embracing’ or ‘sweeping’ claims – they are very difficult to substantiate and should be qualified. Here is an example of an all-embracing claim for ticagrelor: without any information about what exactly ‘long term proof’ refers to in the Pegasus trial it is too broad to be able to substantiate