Jim Shannon – 2016 Parliamentary Question to the Department of Health

The below Parliamentary question was asked by Jim Shannon on 2016-07-19.

To ask the Secretary of State for Health, what assessment his Department has made of the level of compliance with Medicines and Healthcare products Regulatory Agency regulations which state that biosimilars should be subject to additional monitoring until the safety of such drugs is well established.

Nicola Blackwood

In accordance with European Union pharmacovigilance legislation, biosimilar products authorised in the EU since 1 January 2011 must undergo additional monitoring. The European Medicines Agency maintains and publishes a list of medicines subject to additional monitoring. These medicines are readily identifiable by an inverted black triangle which appears on the product information which is available to health professionals and patients.