New black triangle scheme

The MHRA black triangle list, which identifies medicines subject to intense safety scrutiny, has been replaced by an EU-wide 'additional monitoring' list.

Adverse drug reactions can be reported using the Yellow Card at the back of MIMS in print or online on the MHRA website  | SCIENCE PHOTO LIBRARY
Adverse drug reactions can be reported using the Yellow Card at the back of MIMS in print or online on the MHRA website | SCIENCE PHOTO LIBRARY

Medicines included on the new list, maintained by the European Medicines Agency, will continue to be denoted by a black triangle (▼) and monitoring requirements remain the same, with prescribers still required to report any adverse events via the Yellow Card scheme

The list includes the following:

  • new active substances authorised in the EU after 1 January 2011;
  • biological medicines, such as vaccines or medicines derived from plasma, for which there is limited post-marketing experience;
  • medicines with conditional approval (where more data are required) or approved under exceptional circumstances (where there are specific reasons why the company cannot provide a comprehensive set of data);
  • medicines for which additional studies are required (for instance, to provide more data on long-term use of the medicine or on a rare side-effect seen during clinical trials).

The black triangle symbol and information about additional monitoring will be included on Summaries of Product Characteristics and Patient Information Leaflets from September 2013.

Follow MIMS on Twitter

Want news like this straight to your inbox?
Sign up for our bulletins

Have you registered with us yet?

Register now to enjoy more articles and free email bulletins

Register
Already registered?
Sign in

More from MIMS

Long-term antipsychotic use linked to breast cancer

Long-term antipsychotic use linked to breast cancer

Recent research indicates a significant increase in...

Drug shortages - live tracker

Drug shortages - live tracker

Use our constantly updated shortages tracker to check...

Products coming soon - live tracker

Products coming soon - live tracker

EXCLUSIVE TO SUBSCRIBERS Monitor forthcoming UK drug...

SGLT2 inhibitors backed for cardiovascular prevention in draft NICE guidance

SGLT2 inhibitors backed for cardiovascular prevention in draft NICE guidance

SGLT2 inhibitors should be considered as first-line...