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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.”.
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