Legal status and reclassification

Legal status
The sale, supply and administration of all medicines available in the UK is regulated by the Medicines and Healthcare products Regulatory Agency (MHRA). 

Over-the-counter (OTC) medicines are classified into two legal categories which determine how they can be supplied to the public. These are:

Pharmacy (P) – P medicines can only be sold or supplied at registered pharmacy premises by or under the supervision of a pharmacist.

General sale list (GSL) - GSL medicines can be sold from a wider range of premises such as supermarkets, provided those premises can be closed to exclude the public (i.e. they are lockable) and the medicines are pre-packed. There are, however, a number of exemptions from these restrictions.

Reclassification from POM to P
The first ingredient to move from prescription only (POM) to pharmacy status (P) was ibuprofen in 1983.  Since then a steady stream of ingredients have continued to switch from POM to pharmacy status P, allowing a significant proportion of the population to self-treat successfully and take responsibility for their own healthcare. 

PAGB believes that with mounting pressure on the already over-burdened NHS, wider access to appropriate medicines and support for self care becomes increasingly important.

Before a medicine can be reclassified from POM to P, MHRA considers if it is possible for the medicine to be safely used without the supervision of a doctor.  Safety is paramount when a switch is considered. 

The process to reclassify a medicine is generally initiated by the manufacturing company making an application to MHRA. 

Further information on the criteria and procedure for reclassification can be found on the MHRA website

PAGB keeps an updated list of the ingredients which have been switched from POM to P.  To download it click here


PAGB / MHRA Conference Celebrating 25 years of POM to P switching - Video podcasts

 

 

 

 

PAGB and the Medicines and Healthcare products Regulatory Agency MHRA held a joint reception to celebrate 25 years of switching medicines (on 4 December 2008).

As well as looking back over the successes of the past 25 years, discussion focussed on the future for switching in the UK, including the contribution reclassification can play in public health, how the regulatroy framework can be improved and questioning whether all the medicines suitable for switching have already been switched.

Watch key films of the event in several ways:
  1. On computer using the Quicktime player
  2. Watch them in iTunes
  3. Subscribe and download them to your iPod (with the right lead you can plug your iPod into a TV)

To access the video podcasts from the event click here