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3.—(1) No person shall sell a medical food unless—
(a)its formulation and composition comply with Article 3 of the Directive as read with the Annex thereto and its instructions for use are such that its use in accordance with those instructions would so comply;
(b)the name under which it is sold complies with Article 4(1) of the Directive; and
(c)it is labelled in accordance with Article 4(2) to (5) of the Directive.
(2) No person who, in respect of medical food of a particular type—
(a)is a designated notifier, that is to say a manufacturer or an importer covered by Article 5 of the Directive, but
(b)has failed to comply with the requirement to notify the competent authority referred to in that Article,
shall sell a medical food of that type.
(3) For the purposes of paragraph (2) the competent authority is the Food Standards Agency.
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