List of medicines under additional monitoring published

26 April 2013

The Pharmacovigilance Risk Assessment Committee (PRAC) has published the European so-called ‘mandatory’ list of medicines under additional monitoring.

Additional monitoring status is always applied to a medicine in the following cases:

• it contains a new active substance authorised in the EU after 1 January 2011
• it is a biological medicine, such as a vaccine or a medicine derived from plasma (blood), for which there is limited post-marketing experience
• it has been given a conditional approval (where the company that markets the medicine must provide more data about it) or approved under exceptional circumstances (where there are specific reasons why the company cannot provide a comprehensive set of data)
• the company that markets the medicine is required to carry out additional studies, for instance, to provide more data on long-term use of the medicine or on a rare side effect seen during clinical trials

The additional monitoring list will replace the black triangle list previously published each month by the Medicines and Healthcare Products Regulatory Agency (MHRA and will be published monthly on the MHRA website at www.mhra.gov.uk/blacktriangle. It will also be available on the European Medicines Agency website.

There are some differences between the Black Triangle list last published by the MHRA and that of the EU additional monitoring list published on 25 April 2013, which only includes products meeting the ‘mandatory’ reasons for inclusion. An ‘optional’ scope list of further medicines that Competent Authorities have concluded to require additional monitoring is expected to be published later in 2013 once agreed by the PRAC. Marketing authorisation holders should be aware that products which are not currently included in the initial EU additional monitoring list may be added (eg. reinstated from the UK black triangle list) later in 2013 once the final list is agreed by the PRAC.

For medicines previously listed as UK black triangle (according to the latest list published 19 March 2013) but not be present on the published ‘mandatory’ EU additional monitoring list, MAHs can remove black triangle status without contacting the MHRA.