Legal status and reclassification                                                                                                                Home

UK legislation recognises three legal categories of medicines:
POM (Prescription Only Medicines): may only be prescribed by a doctor
P : available in a pharmacy without prescription, under the supervision of a pharmacist
GSL (General Sales List Medicines): on general sale.

The legal status of medicine can be switched, commonly from either a POM to P medicine or a P to GSL medicine. This is known as reclassification.

If there is sufficient evidence of safety, a POM medicine may be reclassified for sale or supply under the supervision of a pharmacist (P). Pharmacy medicines which have been safely used for several years may be suitable for general sale and may be reclassified as GSL.

POM, P, and GSL versions of the same product require different brand names. The exception where the same brand name can be used is if the change in legal supply status is due only to a difference in pack size.

Amended Article 74a of Directive 2001/83/EC, allows for one year of data protection following the authorisation of the initial change of classification of a medicinal product, provided the change is authorised on the basis of significant pre-clinical tests or clinical trials.

The first switch POM to P switch in the UK was made to oral ibuprofen in 1983, with other notable products including the emergency contraceptive pill, simvastatin for lowering cholesterol, zolmitriptan for migraine relief and naproxen for period pain.

There are clear guidelines issued by MHRA as the conditions a product must meet in order to be suitable for reclassification and the data required if such an application is to be made.

EU
Reclassification of prescription only medicines (POM) to pharmacy status (P) in the EU for Alli
March 2009

The POM-P reclassification of Alli (Orlistat) 60mg has been approved by the European Commission.This is a newer lower strnght of the POM medicine Xenical 120mg. The indication is 'alli is indicated for weght loss in adults who are overweight (body mass index, BMI =28 kg/m2) and should be taken in conjunction with a mildy hypocalorific, lower- fat diet.'
http://www.emea.europa.eu/humandocs/Humans/EPAR/alli/alliM2.htm

UK
Reclassification of prescription only medicines (POM) to pharmacy status (P) in the UK - 25 years
December 2008

POM to P switches date back 25 years to the first switch in 1983 for oral ibuprofen. Since this first switch other substances followed in the 1980's and 1990's which have now have established household use such as Loratidine, Cetirizine, Acrivastine (hay fever treatments), Nicotine replacement transdermal patches (smoking cessation), Aciclovir (viral infections of the lips/face), Cimetidine and Ranitidine hydrochloride (heartburn, dyspepsia), Minoxidil (alopecia androgenetica), and Fluconazole (vaginal candidiasis). In 2001 the emergency contraceptive Levonorgestrel switched, followed by significant switches for topical Diclofenac (pain), and then in 2003 Omeprazole (heartburn) and in 2006 Sumatriptan (migraine). In 2008 switches for Naproxen (primary dysmenorrhoea), Azithromycin (chlamydia infections) and Diclofenac potassium (pain).