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Paragraph 15 Reclassification variation application

Original text. Later amendments are not shown.

A reclassification variation application is an application for variation of a marketing authorization which has the effect that a medicinal product to which that authorization relates—

(a)

is to be available only from a pharmacy or on general sale, where previously it was available only on prescription; or

(b)

is to be available on general sale, where previously it was available only from a pharmacy.