Recent reclassifications

Please see the relevant entry in List C (consolidated list of substances present in authorised products which have been reclassified since 1 April 2002) for full details.

Recent reclassifications
Updated 21 August 2008

POM to P (Prescription only medicine to pharmacy)

• Azithromycin: azithromycin 500mg tablets may now be supplied for the treatment of confirmed asymptomatic Chlamydia trachomatis genital infection in individuals aged 16 years and over, and for the epidemiological treatment of their sexual partners
• Diclofenac potassium: tablets containing 12.5mg diclofenac potassium may be supplied without a prescription for the short term relief of headache, dental pain, period pain, rheumatic and muscular pain, backache and the symptoms of colds and flu, including fever, in adults and children aged 14 years and over
• Naproxen: naproxen 250mg tablets may now be supplied without a prescription for the treatment of primary dysmenorrhoea in women aged between 15 and 50 years
• Chloramphenicol: the conditions for P supply of chloramphenicol now include 1% eye ointment (in addition to the 0.5% eye drops). 

P to GSL (Pharmacy to general sale list)

• Paracetamol: The maximum strength of GSL liquid paracetamol preparations for use by adults and children aged 12 years and over, has been increased from 2.5% to 5%
• Loperamide hydrochloride: an additional indication for GSL medicines containing 2mg loperamide hydrochloride has been introduced. The products may now be supplied on general sale for the symptomatic treatment of acute episodes of diarrhoea associated with irritable bowel syndrome in adults aged 18 years and over following initial diagnosis by a doctor.
• Diclofenac diethylammonium: The maximum pack size of diclofenac diethylammonium 1.16% gel that may be supplied on general sale has been increased from 30g to 50g.
• Nicotine: nicotine inhalator may now be supplied on general sale as an aid to smoking cessation and also as an aid to smoking reduction prior to cessation.
• Hydrocortisone:  hydrocortisone 1% cream can now be supplied GSL for the treatment of insect bites and stings only, in adults and children aged 10 years and over.
• Bifonazole:  bifonazole 1% cream has been reclassified as a GSL medicine for the treatment of athlete’s foot.
• Cetirizine:  the maximum GSL pack size for cetirizine tablets has been increased from 7 to 14 tablets.
• Benzocaine:  benzocaine 10% mouth gel can be supplied GSL for the temporary relief from the pain and tenderness associated with mouth ulcers and from wearing dentures.
• Minoxidil:  the conditions for GSL supply of minoxidil 2% now include a gel presentation (in addition to the solution).
• Paracetamol:  the maximum pack size permitted for GSL supply of paracetamol 5% oral suspension in unit packaging, has been increased from 10 to 12 sachets.

Additional product information requirements

• Ibuprofen:  the additional product information requirements for P and GSL ibuprofen, and for P and GSL ibuprofen lysine, have been amended following an update of MHRA guidance on the minimum clinical particulars for P and GSL ibuprofen for systemic administration.
• Sumatriptan:  the additional product information requirements for P sumatriptan have been updated following successful validation of the common diagnostic protocol.
• Cetirizine: the additional product information requirement for GSL cetirizine, that tablet preparations should have a brand name rather than a generic name, has been removed.

Change to List B (Consolidated list of substances which are present in authorised medicines for general sale)
The entry for formaldehyde solution in List B has been amended; it now includes products for external use other than dentifrices. This amendment corrects an earlier administrative oversight and reflects products first authorised as GSL in 1990. This opportunity has been taken to amend the entry title from ‘formaldehyde solution’ to ‘formaldehyde’.

Applications turned down
Following concerns raised during the public consultation exercise, Commission on Human Medicines (CHM) have advised against the reclassification of fluconazole 150mg capsules from P to GSL.

Contact for further information
For further information, please contact our Reclassification Unit, 14-1, MHRA, Market Towers, 1 Nine Elms Lane, London SW8 5NQ, telephone 020 7084 2523 (advice on applications) or 020 7084 2389 (on process), fax 020 7084 2293 or e-mail reclassification@mhra.gsi.gov.uk.