Citation, commencement and interpretation

1. —(1) This Order may be cited as the Medicines (Products Other Than Veterinary Drugs) (General Sale List) Amendment Order 2001 and shall come into force on 31st May 2001.

(2) In this Order—

(a) “the principal Order” means the Medicines (Products Other Than Veterinary Drugs) (General Sale List) Order 1984( 3 );

(b) “Table A of Schedule 1” means Table A (internal or external use) of Schedule 1 to the principal Order (which specifies the class of medicinal products, other than products the subject of a product licence of right, on general sale by virtue of article 2(a) of the principal Order);

(c) “Table B of Schedule 1” means Table B (external use only) of Schedule 1 to the principal Order.

Amendment of Article 1 of the principal Order

2. In article 1 of the principal Order (interpretation)—

(a) there is inserted in article 1(2)(a) immediately after the definition of “irrigation” the definition—

“ “Maximum amount released” means the maximum amount of the substance by weight released by a product during the period for which the product is to be applied continuously to the skin; ” ; and

(b) there is inserted in article 1(3)(a) immediately after the abbreviation of “gram” the abbreviation—

• “ “hrca” for hours of continuous application ” .

Amendment of Schedule 1 to the principal Order

3. For article 1(1) of Schedule 1 to the principal Order there shall be substituted the following:—

“ (1) a substance listed in column 1 of Table A where—

(a) the maximum strength of the substance in the medicinal product does not exceed the maximum strength, if any, specified in column 2 of Table A; and

(b) the maximum amount released of the substance by the product does not exceed the maximum amount released, if any, specified in column 2 of Table A; ” .

Amendment of Table A of Schedule 1 to the principal Order

4. —(1) In the heading of column 2 of Table A of Schedule 1 to the principal Order for the words “Maximum strength” there are substituted the words “Maximum strength or maximum amount released”.

(2) In Table A of Schedule 1 to the principal Order—

(a) there is inserted in column 1, at the appropriate place in the alphabetical order of entries as they appear in that column, the entry “Gum Ammoniacum”;

(b) against the entry in column 1 for “Cetylpyridinium Chloride”—

(i) in column 3, there are inserted the entries—

“ (1) All preparations other than liquid preparations for oral administration

(2) Liquid preparations for oral administration ” ; and

(ii) in column 4, the entry “3 mg (MD)” is numbered “(1)” and, after that entry, there is inserted the entry “(2) 5 mg (MD)”; and

(c) against the entry in column 1 for “Nicotine”( 4 )—

(i) in column 2, for the entry “2 mg” there is substituted the entry “(1) 4 mg” and, after that entry, there are inserted the entries “(2) 1 mg”, “(3) 15 mg in 16 hrca”, and “(4) 21 mg in 24 hrca”;

(ii) in column 3, there are inserted the entries—

“ (1) Chewing gum

(2) Lozenges

(3) Transdermal patches for continuous application to the skin for a period of 16 hours

(4) Transdermal patches for continuous application to the skin for a period of 24 hours ” ; and

(iii) in column 3, for the entry “Chewing gum for the relief of nicotine withdrawal symptoms as an aid to smoking cessation only” there is substituted the entry “In relation to any of the preparations (1), (2), (3) and (4), for the relief of nicotine withdrawal symptoms as an aid to smoking cessation only”.

Amendment of Table B of Schedule 1 to the principal Order

5. In Table B of Schedule 1 to the principal Order against the entry in column 1 for “Clotrimazole”( 5 ), in column 3 there is subsituted for the entry “For treatment of tinea pedis (athlete’s foot) only”, the entry “Powders for the prevention of, or as an adjunct to the treatment of, tinea pedis (athlete’s foot), and all preparations other than powders, for the treatment of tinea pedis”.