Brussels, 7 March 2013
Questions and answers: New 'black symbol' for medicinal products
What is the black symbol?
The black symbol will be accompanied by wording to encourage healthcare professionals and patients to report suspected adverse reactions (side effects) to these medicinal products.
Why has it been introduced?
The EU adopted new pharmacovigilance legislation in 2010 to strengthen the existing rules and improve patient safety through better prevention, detection and assessment of adverse reactions to medicines. Under the new rules, medicinal products that are subject to additional monitoring after they have been placed on the market must be identified. Based on the recommendation of the European Medicines Agency, the Commission chose a black inverted triangle as the symbol to appear in product information, including the leaflet inside the medicine pack.
On which medicines will the black symbol be used?
The black symbol will be used to identify the following categories of medicinal products:
All products with a new active substance authorised after 1 January 2011;
biological medicinal products, such as vaccines or plasma derived products authorised after 1 January 2011; and
products for which certain additional information is required post-authorisation, or for which authorisation is subject to conditions or restrictions regarding their safe and effective use.
Are medicines that require a black symbol dangerous?
No. All centrally authorised medicinal products on the EU market have undergone rigorous tests to demonstrate their quality, safety and efficacy and to prove that their benefits outweigh their risks. Although authorised medicinal products have been extensively tested, it is important to continue to monitor their use once on the market, and look out for adverse reactions that are not listed in the product information.
The black symbol is intended to identify the medicines which are subject to more intensive post marketing monitoring (additional monitoring), so that new emerging information can be immediately shared with the regulatory authorities, medical communities, marketing authorisation holders and patients.
For new biological medicinal products and those containing new active substances, the black symbol will normally be removed after five years, once the use of the product is established.
When will the black symbol be introduced?
It will be introduced on 1 September 2013.
All new medicinal products requiring additional monitoring authorised after this date will include the black symbol in the patient information leaflet and in the information to the doctors, pharmacists, nurses and other healthcare professionals (the summary of product characteristics). For such types of medicinal products authorised prior to 1 September 2013, the black symbol will be introduced into the product information gradually.
Why was the inverted black triangle selected?
Following input from different stakeholders, the European Medicines Agency identified two main options for the black symbol – an inverted black triangle and a magnifying glass.
In October 2012, the European Medicines Agency recommended that the black symbol should be a black inverted equilateral triangle. The recommendation took into account the views of patients and healthcare professionals represented in the Patients' and Consumers' Working Party and the Healthcare Professionals' Working Group established by the European Medicines Agency.
When making the recommendation the following points were considered:
an abstract symbol that is not linked to any inherent meaning or connotation, is less likely to cause confusion, an incorrect interpretation or alarm to patients;
the inverted triangle does not clash with other symbols already established for medicinal products;
solid representation is easy to reproduce in a consistent manner.
Should I only report adverse reactions for medicines that carry the black symbol?
You are encouraged to report adverse reactions (side effects) of any medicine to your doctor, pharmacist or nurse, or you can report them directly through the national reporting system.
How can I report adverse reactions to medicines?
National authorities in Member States and the marketing authorisation holder responsible for medicinal products must have systems in place to collect information about suspected adverse reactions to medicinal products.
You can report adverse reactions to your doctor, pharmacist, nurse or other healthcare professional. The package leaflet will include the details of how to report adverse events through the national reporting system.