UK's MHRA approves GSL switch for allergy test

UK's MHRA approves GSL switch for allergy test

1 August 2019 - Deborah Wilkes

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has given the go-ahead for a skin patch that screens for allergies to paraphenylenediamine (PPD) – a common component of hair colourants – to be switched from a prescription-only medicine to general-sale list (GSL) status.

The Colourstart Test Patch will be available without a prescription for adults and adolescents aged 16 years and older.

The MHRA started consulting on the proposed switch in October 2018 (click here to read the News story).

Supermarkets and hair dressing salons

Consultation document ARM97 noted that the Colourstart Test Patch had been licensed as a prescription-only medicine in 2012 but was not currently marketed.

The product licence holder – Trichocare Diagnostics – said it wanted to make the skin patch available in general-sale outlets such as supermarkets and hair dressing salons.

Noting that PPD caused allergic reactions that could be severe in some cases, ARM97 said 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.

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