UK consults on OTC switch for allergy test

23 October 2018 - Deborah Wilkes

A skin patch that screens for allergies to paraphenylenediamine – a common component of hair colourants that is also known as PPD or para – could soon be available without a prescription in the UK.

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) is consulting on a proposal to reclassify the Colourstart Test Patch from a prescription-only medicine to general-sale list (GSL) status.

Supermarkets and hair dressing salons

Consultation document ARM97 notes the Colourstart Test Patch was licensed as a prescription-only medicine in 2012 but is not currently marketed. The product licence holder – Trichocare Diagnostics – wants to make the skin patch available in general-sales outlets such as supermarkets and hair dressing salons.

ARM97 points out that the UK's Commission on Human Medicines has advised that the patch could be made available as a GSL medicine.

Noting that PPD causes allergic reactions that may be severe in some cases, ARM97 says the Colourstart Test Patch would be the first medicine containing PPD to be available without a prescription in the UK.

The Colourstart Test Patch is a self-adhesive plaster for use on the skin that consists of two patches, an active patch containing 65 micrograms of PPD and a control patch containing no PPD. It should be used prior to applying hair colourant, and is suitable for people aged 16 years and over.

The deadline for comments to reach the MHRA is 7 November 2018.

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