Regulatory Focus™ > News Articles > New EU Labeling Requirement Adopted, Some Novel Medicines to See 'Black Triangle' Symbol

New EU Labeling Requirement Adopted, Some Novel Medicines to See 'Black Triangle' Symbol

Posted 07 March 2013 | By Alexander Gaffney, RAC 

The European Commission (EC) today announced its adoption of a regulation that will see an inverted triangle adorn the leaflets of medical products undergoing additional safety monitoring despite having received approval.

The symbol, adopted as part of a regulation stemming from the 2011 EU pharmacovigilance legislation, is supposed to be proportional to the text it accompanies, with each side of the triangle no smaller than 5 mm in length.

The regulation notes that the triangle is intended to allow patients and healthcare professionals to easily and quickly identify which products are subject to additional monitoring to allow them to report suspected adverse events.

The rule comes into effect on 1 September 2013, and will apply to all non-generic medicinal products authorized after 1 January 2013, including biological medicinal products. Also included: all products approved before 1 January 2013 that are subject to additional monitoring, which must have the symbols on their packaging by 31 December 2013. Extensions may be granted on a case-by-case basis as requested if the sponsor can show that the change would "unduly affect the appropriate and continued supply of the medicinal product."

Existing stock "produced, packaged and labeled" before 1 January 2014 can be marketed even without the black symbol "until stocks are exhausted," the regulation states.

The regulation is binding in all Member States of the EU.


Tags: regulation

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe