Citation, commencement and interpretation

1. —(1) This Order may be cited as the Prescription Only Medicines (Human Use) Amendment Order 2001 and shall come into force on 24th August 2001.

(2) In this Order, “the principal Order” means the Prescription Only Medicines (Human Use) Order 1997( 3 ).

Amendment of article 1(5) of the principal Order

2. In article 1(5) of the principal Order, for “Schedules 1 to 3” there is substituted “Schedules 1, 2 and 5”.

Amendment of Schedule 1 to the principal Order

3. In Schedule 1 to the principal Order (which specifies substances which, if included in medicinal products, make those products prescription only medicines, and exemptions from the restrictions on the sale and supply of prescription only medicines)—

(a) in relation to the substance Adrenaline, in column 3, after “External” there is inserted “(except ophthalmic)”;

(b) in relation to the substance Fluconazole, in column 3, after “vaginal candidiasis” there is inserted “or associated candidal balanitis”;

(c) in relation to the substance Hydrocortisone Acetate, in column 3, after “haemorrhoids” there is inserted “or in combination with Miconazole Nitrate, for athlete’s foot and candidal intertrigo”;

(d) in relation to the substance Stannous Fluoride, the entries in columns 2 and 3 are each numbered “(1)”, and, after those entries there are inserted the following entries—

in column 2—

• “ (2) 0.4 per ” ; and

in column 3—

“ (2) Dental gels for use in the prevention and treatment of dental caries and decalcification of the teeth ” ;

(e) in relation to the substance Terbinafine Hydrochloride( 4 ), in the entry in column 3, at the beginning there is inserted “Preparations, other than spray solutions, for”; the entries in columns 3 and 5 are each numbered “(1)” and after those entries there are inserted the following entries—

in column 3—

“ (2) Spray solutions for external use for the treatment of tinea corporis, tinea cruris and tinea pedis ” ; and

• in column 5—

  “ (2) Container containing not more than 30ml of medicinal product ” ;

  (f)

  there is inserted in column 1, at the appropriate place in the alphabetical order of the entries as they appear in that column, the entries set out in column 1 in the Table below, and, against those entries, there are inserted in columns 2, 3, 4 and 5 the corresponding entries in columns 2, 3, 4 and 5 in that Table—

  Column 1	Column 2	Column 3	Column 4	Column 5
  Substance	Maximum strength	Use, pharmaceutical form or route of administration	Treatment limitations	Maximum quantity
  Clobetasone Butyrate	0.05 per cent	Cream for use in adults and in children aged 12 years and over, for external use for the short term symptomatic treatment and control of patches of eczema and dermatitis (excluding seborrhoeic dermatitis)		Container or package containing not more than 15g of medicinal product
  Fenticonazole Nitrate		External use (but in the case of vaginal use, only for the treatment of vaginal candidiasis)
  Prochlorperazine Maleate	3mg	Buccal tablets for the treatment of nausea and vomiting in cases of previously diagnosed migraine only. For use in persons aged 18 years and over.	12mg (MDD)	Container or package containing not more than 8 tablets

• ; and

  (g)

  there is inserted in column 1, at the appropriate place in the alphabetical order of the entries in that column, each of the following substances—

• “Amisulpride”

• “Balsalazide Sodium”

• “Benserazide”

• “Brimonidine Tartrate”

• “Carbasalate Calcium”

• “Cefdinir”

• “Cerivastatin Sodium”

• “Donepezil Hydrochloride”

• “Fexofenadine Hydrochloride”

• “Flutrimazole”

• “Irbesartan”

• “Levofloxacin”

• “Mercaptamine Bitartrate”

• “Modafinil”

• “Naratriptan Hydrochloride”

• “Pramipexole Hydrochloride”

• “Reboxetine Mesilate”

• “Sertindole”

• “Temocapril Hydrochloride”

• “Testosterone”

• “Valsartan”.