Explanatory Note
(This note is not part of the Order)
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 the interpretation provisions of the principal Order to add a definition for maximum amount released in relation to products which release a substance over a period of time and to add an abbreviation for hours of continuous application.
Article 3 amends Schedule 1 to the principal Order so that Column 2 of Table A (internal and external use) may also contain entries for maximum amount released in relation to products which release a substance over a period of time.
Article 4 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) by inserting an entry for Gum Ammoniacum, and amending the entries in respect of Cetylpyridinium Chloride to increase the maximum dose for liquid preparations for oral administration from 3 mg to 5 mg, and in respect of Nicotine to increase the maximum strength for chewing gum from 2 mg to 4 mg and to add Nicotine lozenges with a maximum strength of 1 mg and transdermal patches which release a maximum of 15 or 21 mgs of Nicotine during periods of 16 and 24 hours continuous application respectively.
Article 5 amends Table B (external use only) of Schedule 1 to the principal Order by amending the entries in respect of Clotrimazole to add Clotrimazole powder for prevention of, and as an adjunct to the treatment of, tinea pedis (athlete’s foot).
Assessments of the cost to business of complying with this Order have 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.