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The Medicines (Products Other Than Veterinary Drugs) (General Sale List) Amendment (No. 2) Order 2001

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Explanatory Note

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This Order further amends the Medicines (Products Other Than Veterinary Drugs) (General Sale List) Order 1984 (“the principal Order”) which specifies classes of medicinal products which can with reasonable safety be sold or supplied otherwise than by or under the supervision of a pharmacist (the general sale list).

Article 2 amends Table A (internal and external use) of Schedule 1 to the principal Order (medicinal products, other than products the subject of a product licence of right, on general sale)—

(a)in respect of the entry of Ibuprofen, by inserting a reference to liquid preparations of maximum strength 2.0 per cent, for internal use, for the treatment of rheumatic or muscular pain, headache, dental pain, feverishness, or symptoms of colds and influenza, for use in children aged under 12 years, with a maximum dose of 200 mg and a maximum daily dose of 800 mg;

(b)in respect of the entry for Potassium Chloride, by inserting a reference to external use;

(c)in respect of Cetirizine Hydrochloride, to insert an entry for tablets of maximum strength 10 mg, for the symptomatic relief of perennial rhinitis (persistent sneezing), seasonal allergic rhinitis (hayfever) and idiopathic chronic urticaria (itchy rashes), for use in adults and children aged 12 years and over with a maximum daily dose of 10 mg;

(d)in respect of Ibuprofen Lysine, to insert an entry for tablets of maximum strength equivalent to 200 mg ibuprofen, for the treatment of rheumatic or muscular pain, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness or symptoms of colds and influenza, for use in adults and in children aged 12 years and over, with a maximum dose equivalent to 400 mg ibuprofen and a maximum daily dose equivalent to 1200 mg ibuprofen;

(e)in respect of Loratadine, to insert an entry for tablets of maximum strength 10 mg, for the symptomatic relief of perennial rhinitis, seasonal allergic rhinitis and idiopathic chronic urticaria, for use in adults and children aged 12 years and over with a maximum daily dose of 10 mg.

Article 3 amends Table B (external use only) of Schedule 1 to the principal Order by deleting the entry in respect of Potassium Chloride and by amending the entries in respect of Sodium Fluoride to add Sodium Fluoride in the form of mouth rinses.

An assessment of the cost to business of complying with this Order has been made, copies of which have been placed in the libraries of both Houses of Parliament. Further copies may be obtained from the Department of Health, Medicines Control Agency, Information Centre, Room 10-202, Market Towers, 1 Nine Elms Lane, London SW8 5NQ.

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