1AB

Notwithstanding article 3(1)(a), a medicinal product shall not be a prescription only medicine by reason that it contains the substance azelastine hydrochloride where—

a

the medicinal product is indicated only for the treatment of seasonal allergic rhinitis in adults and in children aged not less than 12 years;

b

it is in non-aerosol, aqueous form for nasal administration;

c

it is sold or supplied in a container or package containing not more than 36 doses, each of which contains not more than 140 micrograms of azelastine hydrochloride; and

d

the container or package is labelled to show a maximum dose of 140 micrograms per nostril of azelastine hydrochloride and a maximum daily dose of 280 micrograms per nostril of azelastine hydrochloride.

1AC

Notwithstanding article 3(1)(a), a medicinal product shall not be a prescription only medicine by reason that it contains the substance nizatidine where—

a

the medicinal product is indicated only for the prevention of the symptoms of food-related heartburn in persons aged not less than 16 years; and

b

the container or package is labelled to show a maximum dose of 75 milligrams of nizatidine and a maximum of 4 such doses in any period of 14 days.