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4. In article 4 of the principal Order (medicinal products that are not prescription only)—
(a)in sub-paragraph (a) of paragraph (1K) before “treatment” there is inserted “prevention or”;
(b)the following paragraph is inserted after paragraph (1Z)—
“(1AA) Notwithstanding article 3(1)(a), a medicinal product shall not be a prescription only medicine by reason that it contains the substance budesonide where—
(a)the medicinal product is indicated only for the prevention or 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 10 milligrams of the medicinal product; and
(d)the container or package is labelled to show a maximum dose, and a maximum daily dose, of 200 micrograms per nostril of budesonide.”.
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