Amendment of article 4 of the principal Order
3. In article 4 of the principal Order (medicinal products that are not prescription only) the following paragraphs are inserted after paragraph (1AA)—
“(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.”.