Medicines Healthcare Products Regulatory Agency
The scope and purpose of the Consultation Response is to detail the outcome of the public consultation and subsequent decision of the procedure for reclassification of codeine linctus and codeine oral solutions (referred to as codeine linctus throughout).
The Public Assessment Report presents the MHRAs review of the benefits and risks of codeine linctus and expert advice on management of risks, as advised on by the Commission on Human Medicines.
Further information on the reclassification of codeine linctus can be found in our Drug Safety Update and press release (published February 2024).
Consultation documents for Application to Reclassify a Medicine (ARM) 103 which summarise the proposed reclassification from a pharmacy (P) medicine to a prescription only medicine (POM) of codeine linctus for treatment of dry unproductive cough in adults and children aged over 12 years of age without difficulties in breathing, were posted on the GOV.UK website on 18 July 2023.