Proposal to make Colourstart Test 65mcg Cutaneous Patch available from general sales outlets without prescription
Download the full outcome
Detail of outcome
The Medicines and Healthcare products Regulatory Agency (MHRA) has agreed to reclassify Colourstart Test Patch from a prescription only medicine (POM) to a general sale list (GSL) medicine as a screening test for potential allergic contact dermatitis to paraphenylenediamine (PPD) for use by adults and adolescents aged 16 years and over. See the public assessment report above for more information.
Feedback received
Detail of feedback received
Consultation document ARM 97 which summarises the proposal for prescription only to general sale list (POM to GSL) reclassification of Colourstart Test Patch was posted on the GOV.UK website on 17 October 2018. The deadline for comments was given as 7 November 2018.
Five responses were received. Two responses supported the proposal and three did not support the proposal. The five responses received were from professional bodies/associations and a trade body. The issues raised during consultation were further considered by the CHM before issuing final advice on the proposed reclassification application to the Licensing Authority.
Original consultation
Consultation description
We want to know what you think
Colourstart Test 65mcg Cutaneous Patch is a ready-to-use patch test used to screen for allergy to an ingredient paraphenylenediamine (also known as PPD or `para’) which is the commonest and most well-known component of hair colourants.
PPD is known to cause allergic reactions which may be severe, in some individuals.
Colourstart Test 65mcg Cutaneous Patch is used prior to applying hair colourant. If reaction to the patch test is positive, hair colourant should not be used.
Colourstart Test 65mcg Cutaneous Patch is currently licensed as a prescription only medicine.
We propose to make it available in general sales outlets, such as supermarkets and hair dressing salons, without prescription.
The Commission on Human Medicines has advised that this product can be available as a General Sale List (GSL) medicine. We want to know what you think about this change.
Please tell us your views using the form at the end of the consultation document.
The deadline for comments is 7 November 2018.
Documents
Last updated 1 August 2019 + show all updates
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Added details of consultation feedback and outcome.
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First published.