Amendment of article 4 of the principal Order

3.  In article 4 of the principal Order (medicinal products that are not prescription only), the following paragraph is inserted after paragraph (1D):—

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

(a) it is in the form of granules;

(b) its maximum strength does not exceed one per cent calculated in terms of weight in weight;

(c) it is sold or supplied in a container or package containing not more than 560mg;

(d) its container or package is labelled to show a maximum daily dose of 80mg and a maximum dose of 20mg; and

(e) it is indicated only for treatment, by mouthwash, in adults and in children over the age of 12 years.”.