MEP: Medicines, ethics and practice (May 2008)

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The Pharmaceutical Journal Vol 280 No 7501 p576 10 May 2008
Up-to-date guidance on the legal status of thousands of human medicines is available from a searchable live database on the Royal Pharmaceutical Society's website	List of inspectors (September 2007) Changes to the reclassification procedure

May 2008 cumulative list of amendments

In the first issue of each month The Journal updates the guidance on the legal status of medicines published in the 31st (July 2007) edition of ‘Medicines, ethics and practice: A guide for pharmacists’.

The amendments are given in bold type when added to the list and repeated each month in light type. A product’s legal status can be obtained by consulting first the amendment list and then the guide. The abbreviations used in the list are explained in the key to annotations in the body of the guide (p39).

Human medicines

Actonel Combi (risedronate, calcium, vitamin D3) film-coated tablets and effervescent granules sachets POM

Adcal D3 Dissolve effervescent tablets in packs of four 14-tablet tubes P

Altargo POM

Atriance POM

Bifonazole 1% cream for the treatment of athlete’s foot GSL

Binocrit prefilled syringes POM

Chloramphenicol eye drops entry: delete P from end of entry

Doxadura XL POM

Eucreas tablets POM

Feminax Ultra tablets P

Galvus tablets POM

Gygel GSL

Hydrocortisone 1% cream for the treatment of insect bites and stings only, in adults and children aged 10 years and over GSL

Increlex POM

Inovelon POM

Langdale’s Cinnamon Essence GSL: delete entry

Midazolam CD No Reg POM

Naproxen entry should read: Naproxen tablets POM; but if for the treatment of primary dysmenorrhoea in women aged between 15 and 50 years, maximum strength 250mg, 500mg (MD), 750mg (MDD), for a maximum of 3 days’ treatment, in a maximum pack size of 9 tablets: P

Natecal D3 tablets P

Nicotine inhalator as an aid to smoking cessation and also as an aid to smoking reduction prior to cessation GSL

Orencia injection POM

Pradaxa capsules POM

Rapydan medicated plasters POM

Rasilez POM

Rebetol (ribavarin) 40mg/ml oral solution POM

Vicks preparations GSL: delete entry

Yondelis POM

MEP guide: List of inspectors

There were some errors in the list of contact details for Royal Pharmaceutical Society inspectors which appeared on p113 of the 31st edition (July 2007) of ‘Medicines, ethics and practice: A guide for pharmacists and pharmacy technicians’.

For ease of reference, the correct list of names and telephone numbers is reproduced below

Northern region
David Slater (regional lead inspector)]	020 7572 2567
Stan Brandwood	020 7572 2550
Helen Dolan	020 7572 2577
Sheena Greig	020 7572 2555
Alison Hopkins	020 7572 2557
John Russ Liddell	020 7572 2561
William Rial	020 7572 2558
Stewart Waugh	020 7572 2570
David Young	020 7572 2573

Central region
Jill Williams (regional lead inspector)	020 7572 2572
Richard Chapman	020 7572 2522
Barry Cohen	020 7572 2551
Janet Edginton	020 7572 2553
Steven Gascoigne	020 7572 2554
Julie Hales	020 7572 2541
Akhtar Malik	020 7572 2574
Semina Nawaz	020 7572 2533

Southern region
Tim Snewin (regional lead inspector)	020 7572 2568
Simon Denton	020 7572 2565
Peter Gibbs	020 7572 2559
Richard Groombridge	020 7572 2516
Susan Melvin	020 7572 2562
Sharon Monks	020 7572 2515
Martin Packham	020 7572 2569
Jacqueline Riley	020 7572 2566
Eilean Robson	020 7572 2552

Changes to the reclassification procedure

Users of the guide should note that changes to the reclassification procedure for medicines mean that the legal status of a product now becomes part of its marketing authorisation rather than being determined by the active substance listed in secondary legislation. Because a change of legal status will be conferred only on products that are the subject of an application for reclassification, users of the guide should refer to the entry for the specific proprietary product and not rely only on the entry for the active substance. Since the POM Order remains in force, entries for active substances will remain in the guidance but will include cross references wherever proprietary products have been reclassified. Further guidance or clarification on the status of individual products can be obtained from manufacturers or from the Medicines and Healthcare products Regulatory Agency (tel 020 7273 0523; e-mail info@mhra.gsi.gov.uk).