Consultation outcome

Proposal to make Colourstart Test 65mcg Cutaneous Patch available from general sales outlets without prescription

• From: Medicines and Healthcare products Regulatory Agency
• Published: 17 October 2018
• Last updated: 1 August 2019 — See all updates

This consultation has concluded

Read the full outcome

Colourstart public assessment report

PDF, 265 KB, 15 pages

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

Colourstart BAD response

PDF, 446 KB, 15 pages

Colourstart BSCA response

PDF, 445 KB, 15 pages

Colourstart NPA response

PDF, 143 KB, 2 pages

Colourstart RPS response

PDF, 112 KB, 2 pages

Colourstart CCA response

PDF, 79.9 KB, 1 page

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.

• British Association of Dermatologists (BAD)
• British Society of Cutaneous Allergy (BSCA)
• Royal Pharmaceutical Society (RPS)
• National Pharmacy Association (NPA)
• Company Chemists’ Association (CCA)

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Original consultation

Summary

We are considering making Colourstart Test 65mcg Cutaneous Patch available to buy without prescription from retail outlets. We always want to involve the public and healthcare professionals in decisions that affect them. We want to know what you think about this change.

This consultation ran from
9am on 17 October 2018 to 5pm on 7 November 2018

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

Colourstart consultation document

PDF, 5.2 MB, 28 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.

Colourstart consultation response form

MS Word Document, 213 KB

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 17 October 2018
Last updated 1 August 2019 + show all updates

1. 1 August 2019

   Added details of consultation feedback and outcome.

2. 17 October 2018

   First published.