Codeine Linctus reclassification from P to POM

This week the MHRA announced that codeine linctus would be reclassified to a prescription-only medicine because of the risk of abuse and addiction that comes with it being available over-the-counter. Please see more information here: Codeine linctus to be reclassified to a prescription-only medicine because of risk of abuse and addiction – GOV.UK (www.gov.uk)

We have been seeking clarity around this change and if it will be immediate or if there will be a date this comes into force. The MHRA has advised that whilst, legally, codeine linctus is still a P medicine all existing codeine linctus stock should be treated as POM from the time of MHRA’s announcement.

Market authorisation holders (MAH) are in the process of updating their product licences to reflect the change and within 3 months, MAHs will update their product information and labels. The MHRA is not seeking a recall of the existing stock of codeine linctus, as this would put patients who require this medicine to treat long-term coughs at risk.