On the 01 August 2019, The Medicines and Healthcare products Regulatory Agency (MHRA) announced that the Colourstart Test 65 mcg Cutaneous Patch will be formally reclassified (switched) from a prescription only medicine (POM) to a general sale list (GSL) medicine.

Colourstart, owned by Trichocare Diagnostics Limited UK, is a self-adhesive plaster consisting of two patches, one containing 65 micrograms of paraphenylenediamine (PPD) [active patch] and the other patch with no PPD [control patch]. If there is a positive reaction to the test patch, which is applied to the upper arm, hair colourant should not be used.

This means that for the first time, people aged 16 years and older will be able to buy a medicinal screening test patch from general sale outlets to see if they are allergic to PPD, one of the most common ingredients present in hair dye, before colouring their hair.

Allergic reactions to this ingredient in hair dye can cause itchy rashes, redness and tiny blisters. At its most severe, some people have even been admitted in A&E hospital departments. Deaths whilst infrequent have been attributed to severe PPD reactions from either black henna tattoos or hair dye.

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This change means people will be able to purchase the Colourstart Test, without the need for a doctor’s prescription or a pharmacist’s advice.

To be reclassified from POM to GSL, a medicine must meet both the requirements of POM to Pharmacy (P) and P to GSL reclassification. Colourstart was assessed firstly against the criteria for a medicine to be reclassified as P and then against the criteria for a medicine to be classified as GSL. Colourstart met the conditions of both POM to P and P to GSL reclassification.

JensonR+ Limited were the team that enabled Trichocare to realise their ambitions to have this patch available as a general sales list medicine. Nick Plunkett owner of Trichocare, the innovators behind the Colourstart test, said “I want to thank the people at JensonR+ Limited for their perseverance and support to help us achieve this remarkable switch from POM to GSL in one procedure”.

JensonR+ Limited have supported and been successful in switching medicines with the aim of increasing access to improve self-care medications and giving consumers greater choice. The aim is simple, but the process can seem complex. We aim to help guide and assist you through the maze of activities to achieve your end goal.

Contact us at consultancy@jensongroup.com.

Janet Worrell