Article 2 Amendment of article 4 of the principal Order

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.”;

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.”.