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.