Consultation outcome

MHRA Public consultation on the proposal to make Codeine Linctus available as a prescription-only medicine (POM)

• From: Medicines and Healthcare products Regulatory Agency
• Published: 18 July 2023
• Last updated: 20 February 2024 — See all updates

This consultation has concluded

Read the full outcome

Consultation response on proposal to make codeine linctus and codeine oral solutions available by prescription only

HTML

Codeine linctus (codeine oral solutions): Proposal to reclassify to prescription only Public Assessment Report (PAR)

PDF, 476 KB, 31 pages

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Detail of outcome

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 MHRA’s 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.

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Original consultation

Summary

The Medicines and Healthcare Products Regulatory Agency (MHRA) have launched a public consultation to propose reclassification of Codeine Linctus to prescription-only medicine.

This consultation ran from
12:01am on 18 July 2023 to 11:59pm on 15 August 2023

Consultation description

The MHRA are consulting on the availability of Codeine Linctus as a pharmacy medicine or whether to reclassify as a prescription-only medicine where access will only be given on presentation of a doctor’s prescription.

Codeine Linctus is an oral solution or syrup with the active ingredient codeine phosphate and is used to stop an unproductive or dry cough.

The consultation is launched in response to multiple reports that Codeine Linctus is being used recreationally for its opioid effects, rather than for its intended use as a cough suppressant.

All members of the public are asked their views on whether cough medicines containing the opioid codeine, should be restricted to prescription-only. Your views will help to gather important information on your experiences and make an informed decision on the best way to minimise risks associated with misuse and for the benefit of patients, carers and healthcare professionals – see further information about the consultation.

Ways to respond

You will be able to respond on online directly from the consultation .

Documents

Proposal to make Codeine Linctus and Codeine Oral Solutions available as a prescription only medicine (POM)

PDF, 315 KB, 15 pages

This file may not be suitable for users of assistive technology.

Request an accessible format.

If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email webupdates@mhra.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

Published 18 July 2023
Last updated 20 February 2024 + show all updates

1. 20 February 2024

   Consultation response published.

2. 18 July 2023

   First published.