MHRA - Brief Summary Of Reclassifications That Have Been Approved In The Past 12 Months, UK

Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Pharmacy / Pharmacist
Article Date: 05 Jan 2009 - 1:00 PDT

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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 December 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

P to GSL (Pharmacy to general sale list)

-- Nicotine: nicotine patches releasing 25mg over 16hours of continuous application may now be supplied on general sale as an aid to smoking cessation.

-- Sodium cromoglicate: sodium cromoglicate 2% eyedrops may be supplied on general sale for the relief and treatment of the eye symptoms of hay fever, in adults and children aged 6 years and over.

-- Paracetamol: paracetamol 5% oral suspension, for use in children aged 6 to 12 years, may now be supplied GSL in multidose containers in a quantity not exceeding 80ml.

-- Paracetamol: The maximum strength of GSL liquid paracetamol preparations for 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 as an aid to smoking reduction prior to cessation.

Additional product information requirements

-- Azithromycin: the additional product information requirements for azithromycin have been updated.

-- 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 withdrawn

The P to GSL application which was the subject of ARM 27, has been withdrawn by the marketing authorisation holder, for commercial reasons.

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.

http://www.mhra.gov.uk

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