The Medicines (Products Other Than Veterinary Drugs) (Prescription Only) Amendment (No. 2) Order 1992

Amendment of article 4 of the principal Order

2.  In article 4 of the principal Order (medicinal products that are not prescription only), the following paragraph is substituted for paragraph (1E):—

“(1E) Notwithstanding article 3(1)(a), a medicinal product shall not be a prescription only medicine by reason that it contains the substance carbenoxolone sodium where—

(a) the medicinal product is in the form of granules;

(b) the maximum strength of the carbenoxolone sodium in the medicinal product does not exceed one per cent calculated in terms of weight in weight;

(c) the medicinal product is sold or supplied in a container or package containing not more than 560 milligrams of carbenoxolone sodium;

(d) the container or package of the medicinal product is labelled to show a maximum daily dose of 80 milligrams of carbenoxolone sodium and a maximum dose of 20 milligrams of carbenoxolone sodium; and

(e) the medicinal product is indicated only for treatment by mouthwash, in adults and in children over the age of 12 years;

and for the purposes of this paragraph “maximum daily dose” means the maximum quantity of the substance carbenoxolone sodium which it is recommended should be used as a mouthwash in a period of 24 hours and “maximum dose” means the maximum quantity of the substance carbenoxolone sodium which it is recommended should be used at any one time.”.