A new symbol makes it easier to identify risk minimisation materials

Fimea instructs marketing authorisation holders to introduce a new symbol for additional risk minimisation materials and direct healthcare professional communications intended for healthcare professionals.   

The purpose of the medicine safety information symbol is to make it easier to distinguish risk minimisation materials from other types of communications, such as marketing materials. The new symbol is being introduced gradually and will be added to doctor’s guides and other materials as they are updated and prepared.  

A recent study shows that healthcare professionals have difficulty identifying risk minimisation materials

The need for clearly distinguishable materials is also supported by research conducted by the University of Helsinki and published in August 2025. According to the survey, healthcare professionals have difficulty identifying the official risk minimisation materials published by marketing authorisation holders. 

– The challenge is that many healthcare professionals do not recognise these materials which are prepared in cooperation with the authorities. This increases the risk that an important message regarding pharmacovigilance is missed and lost among all the other materials, doctoral researcher Andreas Sandberg says in an interview with the Sic! online magazine.

According to the study, it is important to make risk minimisation materials and direct healthcare professional communications stand out with the addition of visual cues such as symbols.   

The pharmaceutical industry has also called for the introduction of a symbol that would make it easier to distinguish between different materials.

The purpose of medication risk management is to support safe treatment 

Additional risk minimisation materials and direct healthcare professional communications are part of the risk management of medicines. The purpose of these materials is to reduce the risks associated with the use of medicines and to ensure safe and effective treatment. 

They are particularly important when the medicinal product is associated with significant risks or requires further guidance on how it should be used. 
Fimea publishes additional risk minimisation materials on its website.

Read more

Different versions of the medicine safety information symbol (pdf)

Sandberg, H.A. et al. Awareness and Experience of Direct Healthcare Professional Communication and Risk Management Plan Educational Material among Healthcare Professionals in Finland (springer.com).

Additional risk minimisation material for medicinal product