Amendment of article 4 of the principal Order2
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.