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2. In article 4 of the principal Order (medicinal products that are not prescription only) —
(a)the following paragraph is inserted after paragraph (1A) —
“(1B) 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 astemizole where—
(a)it is for oral use;
(b)it is not a sustained release preparation;
(c)it is sold or supplied in a container or package containing not more than 100mg;
(d)it is indicated only for the treatment of hay fever in adults or in children over the age of 12 years; and
(e)its container or package is labelled to show a maximum daily dose of 10mg.”;
(b)the following paragraph is substituted for paragraph (3) —
“(3) Notwithstanding Article 3(1)(d), any preparation of insulin for parenteral administration to human beings shall not be a prescription only medicine.”.
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