EMA publishes initial list of medicines requiring black triangle in packaging leaflet

The European Medicines Agency has published the initial list of medicines that are subject to additional monitoring. They will have to display an inverted black triangle in their package leaflet and in the summary of product characteristics (SmPC), together with a short sentence explaining what the triangle means.

The triangle will start appearing in packaging leaflets from autumn this year.

The aim is to encourage healthcare professionals and patients to report any suspected adverse reactions observed with the medicine

The aim is to encourage healthcare professionals and patients to report any suspected adverse reactions observed with the medicine, either because it is new to the market or because there is a limitation to the data available on its safety. If a medicine is labelled with the inverted black triangle, it does not mean that it is unsafe, the Agency said.

Medicines that are subject to additional monitoring are:

• Medicines authorised after 1 January 2011 that contain a new active substance;
• Biological medicines for which there is limited post-marketing experience;
• Medicines with a conditional approval or approved under exceptional circumstances;
• Medicines for which the marketing-authorisation holder is required to carry out a post-authorisation safety study (PASS).

Other medicines can also be placed under additional monitoring, based on a recommendation from the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC).

A medicine can be included on this list when it is approved for the first time or at any time during its lifecycle. It remains under additional monitoring for five years or until the PRAC decides to remove it from the list – usually because studies have further established the safety profile of the product concerned. The complete additional-monitoring list will be reviewed every month by the PRAC and published on the Agency’s website, where additional information on additional monitoring can also be found in all EU languages.

Marketing-authorisation holders of medicines on the list are required to update the product information to include the new black symbol and explanatory text using the latest version of the product-information templates. They should start to include new information in the product information during the course of 2013.

For new medicines, the Agency encourages marketing-authorisation applicants to start using the new product-information template if an opinion from the Committee for Medicinal Products for Human Use (CHMP) is expected this month or in May.

Any new medicine on the list authorised after 1 September 2013 will include the black symbol and the summary of product characteristics when it is placed on the EU market.

For medicines that are already authorised, marketing-authorisation holders are encouraged to use the new template at the next regulatory procedure affecting the product information. If there are no such procedures, companies should submit a type-IAIN variation no later than 31 December.