Last week the European Medicines Agency updated the QRD templates for Summary of Product Characteristics (SmPC) and Package Leaflets (PL), to implement the new EU pharmacovigilance legislation.

A black upside-down triangle is the new symbol to show that a medicine is subject to additional monitoring. From September 2013 onwards, it must be included in the SmPC before section 1 and accompanied by the following standard statements:

[English]

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

[Spanish]

Este medicamento está sujeto a seguimiento adicional, lo que agilizará la detección de nueva información sobre su seguridad. Se invita a los profesionales sanitarios a notificar las sospechas de reacciones adversas. Ver  la sección 4.8, en la que se incluye información  sobre cómo notificarlas.

In the Package Leaflet, the standard statements are:

[English]

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

[Spanish]

Este medicamento está sujeto a seguimiento adicional, lo que agilizará la detección de nueva información sobre su seguridad. Puede contribuir comunicando los efectos adversos que pudiera usted tener. La parte final de la sección 4 incluye  información sobre cómo comunicar estos efectos adversos.

The symbol will apply to:

• all medicines that contain a new active substance and all biological medicines authorised after 1 January 2011;
• medicines for which certain additional information is required after authorisation;
• medicines subject to conditions or restrictions on their safe and effective use.

In the UK, the MHRA has had a Black Triangle Scheme for many years that lists new marketed drugs under intensive surveillance. This list will now be replaced by the EMA Additional Monitoring scheme, to avoid overlapping.

More details are available in the EMA Implementation Plan for the new pharmacovigilance requirements. The updated templates can be downloaded in all official EU languages, as well as Icelandic, Norwegian and Croatian, from the EMA product information page. (See screenshot below.)

If you’re a medical translator and you’d like to learn more about using these templates, why not check out my blog post on “A Translator’s Guide to the EMA templates”.