On 7 March 2013, the European Commission adopted a black triangle as the symbol to be placed on the patient information leaflets and the Summary of Product Characteristics (“SmPC”) of medicinal products “subject to additional monitoring” in the European Union (“EU”).
The history of the black triangle
The requirement to include a black symbol in information related to certain types of medicinal products was introduced as part of the new EU pharmacovigilance rules that became applicable in July 2012. The newly established Pharmacovigilance Risk Assessment Committee (“PRAC”) of the European Medicines Agency was expected to recommend a black symbol to the European Commission not later than 2 January 2012. After some delay, the PRAC recommended the black triangle on 3 October 2012. Following this recommendation and a public consultation, the European Commission has adopted an Implementing Regulation introducing the black triangle.
What is the black triangle? What is its purpose?
The black symbol chosen by the European Commission is in the form of an inverted black triangle “▼”. The purpose of the black triangle is to attract the attention of patients and healthcare professionals to the fact that the medicinal product is subject to additional monitoring in the EU.
The black triangle must be accompanied by a text encouraging patients and healthcare professionals to report any unexpected adverse events experienced in the treatment with these products.
Which medicinal products are affected?
The requirement to place the black triangle on the patient information leaflet and SmPC applies to medicinal products that are subject to additional monitoring in the EU. These are:
- medicinal products that contain a new active substance which was not contained in any medicinal product authorised to be placed on the market in the EU prior to 1 January 2011;
- any biological medicinal product authorised to be placed on the market in the EU after 1 January 2011;
- medicinal products subject to a conditional marketing authorisation or subject to restrictions and conditions ensuring their safe and effective use.
The requirement will mainly affect highly innovative medicinal products and recently authorised and future biological medicinal products including vaccines and medicinal products that contain human or animal-derived materials. The requirement will also apply to recently authorised and future medicinal products developed by recombinant DNA technology, controlled expression of genes coding or hybridoma and monoclonal antibody methods, including biosimilars.
What are the practical implications?
In practice, marketing authorisation holders for medicinal products subject to additional monitoring will be required to add the black triangle to patient information leaflets and the SmPCs for their products through variations of related marketing authorisations. This variation should be implemented before 1 September 2013.
However, medicinal products that have been produced, packaged and labelled before 1 January 2014 and that do not include the black triangle in related patient information leaflets may continue to be placed on the EU market.