Every day I pass this plaque as I enter the Innovation building (R3) to access my office in Biocity. By plaque I mean the ornamental tablet that is fixed to a wall or other surface in commemoration of a person or event… rather than a wall of dental detritus. I barely acknowledge it or reflect upon the impact such a simple statement has made to healthcare across the world. RIP Dr Stewart Adams, 30 Jan 2019. Its time to reflect.

Any regulatory affairs professional who has worked in the Nottingham environs, over the past 30 years will have at one time or another worked on an ibuprofen concept. Nurofen was the power brand in Boots Healthcare International armoury, supported by a team of professionals within D6 on the Boots Beeston site. Some amazing OTC products sprung up and remain on the market today from those days. The baton passed to Reckitt Benckiser in 2005/6 and the brand continues to grow. My personal involvement in OTC medicines continues, across a wider spectrum than just one molecule.

As a graduate pharmacist I remember the countless prescriptions dispensed for Brufen, the prescription parent of Nurofen. Its been an interesting journey for this molecule. Ibuprofen was reclassified from a Prescription only medicine (POM) to pharmacy medicine (P) and then to a General Sales List medicine (GSL), opening up access to pain relief for millions. Its a classic reclassification tale, as sales and pharmacovigilance data are gathered and analysed to support self treatment. In 2003 the World Health Organisation listed ibuprofen on its ‘selection and use of essential medicines’.

Prior to this, on 1 April 2002, the UK began a new reclassification system, where the legal status (prescription only, pharmacy or general sale list) became part of the marketing authorisation rather than determined by the active substance listed in secondary legislation.

This change enabled applications to be dealt with faster by removing the need to amend statutory orders. Observers to public consultations for reclassifications may wonder where the ‘ARM’ designation comes from. As each application has its own consultation, with a dedicated timetable, the MHRA now use  ‘ARM’ (application to reclassify a medicine) to identify this rather than the old MLX prefix used for Ibuprofen. ARM 1 was to reclassify from P to GSL – Regaine Regular Strength and Nizoral Dandruff Shampoo.

Now ARM 97 seeks consultation on Colourstart Test 65mcg Cutaneous Patch (paraphenylenediamine; PPD). Its been a diverse 17 years.

Within OTCexperts we have had the opportunity to be part of many of these ARMs and continue to play our part. So Dr Stewart Adams thank you for stretching my mind and giving me opportunities to develop a love of OTC remedies across the full spectrum of regulation. I shall bow my head in respect as I pass this plaque in future.

MHRA reclassify your product guidance

To read more about the reclassification of medicines, consult this MHRA guidance.
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